Synopsis
Synopsis
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CEP/COS
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EU WC
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KDMF
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NDC API
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VMF
DRUG PRODUCT COMPOSITIONS
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1. 28(b)-lys-29(b)-pro-insulin
2. 28(b)-lysine-29(b)-prolineinsulin
3. Humalog
4. Humalog Kwikpen
5. Insulin, Lys(28b)-pro(29b)-
6. Insulin, Lysyl(28b)-prolyl(28b)-
7. Kwikpen, Humalog
8. Lispro
9. Lispro, Insulin
10. Lyspro
1. 133107-64-9
2. Insulin Lispro (5.97 Mg)
3. Insulin-lispro
4. Dtxsid90157956
Molecular Weight | 5814 g/mol |
---|---|
Molecular Formula | C257H389N65O77S6 |
Hydrogen Bond Donor Count | 84 |
Hydrogen Bond Acceptor Count | 89 |
Rotatable Bond Count | 185 |
Exact Mass | 5811.6913101 g/mol |
Monoisotopic Mass | 5809.6846004 g/mol |
Topological Polar Surface Area | 2310 Ų |
Heavy Atom Count | 405 |
Formal Charge | 0 |
Complexity | 13000 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 52 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Humalog |
PubMed Health | Insulin Lispro |
Drug Classes | Antidiabetic |
Drug Label | Humalog Mix50/50 [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)] is a mixture of insulin lispro solution, a rapid-acting blood glucose-lowering agent and insulin lispro protamine suspension, an intermedi... |
Active Ingredient | Insulin lispro recombinant |
Dosage Form | Injectable |
Route | Injection |
Strength | 100 units/ml |
Market Status | Prescription |
Company | Lilly |
2 of 2 | |
---|---|
Drug Name | Humalog |
PubMed Health | Insulin Lispro |
Drug Classes | Antidiabetic |
Drug Label | Humalog Mix50/50 [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)] is a mixture of insulin lispro solution, a rapid-acting blood glucose-lowering agent and insulin lispro protamine suspension, an intermedi... |
Active Ingredient | Insulin lispro recombinant |
Dosage Form | Injectable |
Route | Injection |
Strength | 100 units/ml |
Market Status | Prescription |
Company | Lilly |
Insulin lispro is indicated to improve glycemic control in adults and children with diabetes mellitus.
FDA Label
Treatment of diabetes mellitus in adults.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilisation of diabetes mellitus.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilization of diabetes mellitus. Liprolog is a short acting insulin and may be used in conjunction with a longer acting human insulin. Liprolog is indicated for preprandial administration.
Insulin is a natural hormone produced by beta cells of the pancreas. In non-diabetic individuals, a basal level of insulin is supplemented with insulin spikes following meals. Increased insulin secretion following meals is responsible for the metabolic changes that occur as the body transitions from a postabsorptive to absorptive state. Insulin promotes cellular uptake of glucose, particularly in muscle and adipose tissues, promotes energy storage via glycogenesis, opposes catabolism of energy stores, increases DNA replication and protein synthesis by stimulating amino acid uptake by liver, muscle and adipose tissue, and modifies the activity of numerous enzymes involved in glycogen synthesis and glycolysis. Insulin also promotes growth and is required for the actions of growth hormone (e.g. protein synthesis, cell division, DNA synthesis). Insulin lispro is a rapid-acting insulin analogue used to mimic postprandial insulin spikes in diabetic individuals. The onset of action of insulin lispro is 10-15 minutes. Its activity peaks 60 minutes following subcutaneous injection and its duration of action is 4-5 hours. Compared to regular human insulin, insulin lispro has a more rapid onset of action and a shorter duration of action. Insulin lispro is also shown to be equipotent to human insulin on a molar basis.
Hypoglycemic Agents
Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)
A10AB04
A10AB04
A10AB04, A10AD04
A10AB04, A10AD04
A10AB04
A - Alimentary tract and metabolism
A10 - Drugs used in diabetes
A10A - Insulins and analogues
A10AB - Insulins and analogues for injection, fast-acting
A10AB04 - Insulin lispro
A - Alimentary tract and metabolism
A10 - Drugs used in diabetes
A10A - Insulins and analogues
A10AC - Insulins and analogues for injection, intermediate-acting
A10AC04 - Insulin lispro
A - Alimentary tract and metabolism
A10 - Drugs used in diabetes
A10A - Insulins and analogues
A10AD - Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting
A10AD04 - Insulin lispro
Absorption
Insulin lispro is rapidly absorbed following subcutaneous administration. It is also absorbed more quickly than regular human insulin. Peak serum levels occur 30-90 minutes after injection in healthy subjects. Absorption also differs depending on the site of injection. After insulin lispro was administered in the abdomen, serum drug levels were higher and the duration of action was slightly shorter than after deltoid or thigh administration. The absolute bioavailability after subcutaneous injection ranges from 55% to 77% with doses between 0.1 to 0.2 unit/kg, inclusive. The mean observed area under the serum insulin concentration-time curve from time zero to infinity was 2360 pmol hr/L and 2390 pmol hr/L for HUMALOG U-200 and HUMALOG U-100, respectively. The corresponding mean peak serum insulin concentration was 795 pmol/L and 909 pmol/L for HUMALOG U-200 and HUMALOG U-100, respectively. The median time to maximum concentration was 1.0 hour for both formulations.
Volume of Distribution
When administered intravenously as bolus injections of 0.1 and 0.2 U/kg dose in two separate groups of healthy subjects, the mean volume of distribution of insulin lispro appeared to decrease with increase in dose (1.55 and 0.72 L/kg, respectively).
Clearance
Clearance is dose dependent. When a dose of 0.1 unit/kg and 0.2 unit/kg were administered intravenously, the mean clearance was 21.0 mL/min/kg and 9.6 mL/min/kg respectively.
Insulin is predominantly cleared by metabolic degradation via a receptor-mediated process.
After subcutaneous administration of insulin lispro, the t1/2 is shorter than that of regular human insulin (1 versus 1.5 hours, respectively).
Insulin lispro binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor autophosphorylates and phosphorylates numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. Activation of these proteins leads to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC), both of which play critical roles in metabolism and catabolism. In humans, insulin is stored in the form of hexamers; however, only insulin monomers are able to interact with IR. Reversal of the proline and lysine residues at positions B28 and B29 of native insulin eliminates hydrophobic interactions and weakens some of the hydrogen bonds that contribute to the stability of the insulin dimers that comprise insulin hexamers. Hexamers of insulin lispro are produced in the presence of zinc and m-cresol. These weakly associated hexamers quickly dissociate upon subcutaneous injection and are absorbed as monomers through vascular endothelial cells. These properties give insulin lispro its fast-acting properties.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4846
Submission : 1983-03-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23892
Submission : 2010-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17123
Submission : 2004-01-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27702
Submission : 2013-11-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32125
Submission : 2017-12-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5527
Submission : 1984-09-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5533
Submission : 1984-09-14
Status : Inactive
Type : II
Registration Number : 217MF10534
Registrant's Address : Lilly Corporate Center, Indianapolis, Indiana 46285, USA
Initial Date of Registration : 2005-09-09
Latest Date of Registration : --
Registration Number : 219MF10053
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2007-03-05
Latest Date of Registration : --
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4846
Submission : 1983-03-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27702
Submission : 2013-11-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23892
Submission : 2010-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17123
Submission : 2004-01-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32125
Submission : 2017-12-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5527
Submission : 1984-09-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5533
Submission : 1984-09-14
Status : Inactive
Type : II
Insulin Lispro (genetical recombination)
Registration Number : 229MF10064
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2017-03-13
Latest Date of Registration : 2017-12-25
Insulin Lispro (genetical recombination)
Registration Number : 219MF10053
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2007-03-05
Latest Date of Registration : 2017-12-25
Insulin Lispro (genetical recombination)
Registration Number : 303MF10175
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2021-12-09
Latest Date of Registration : 2021-12-09
Insulin Lispro (genetical recombination)
Registration Number : 226MF10225
Registrant's Address : Lilly Corporate Center, Indianapolis, Indiana 46285, USA
Initial Date of Registration : 2014-12-08
Latest Date of Registration : 2017-12-25
Insulin Lispro (genetical recombination)
Registration Number : 217MF10534
Registrant's Address : Lilly Corporate Center, Indianapolis, Indiana 46285, USA
Initial Date of Registration : 2005-09-09
Latest Date of Registration : 2017-12-25
About the Company : Wanbang Biopharmaceuticals is a leading anti-diabetic pharmaceutical company in China and a core member of Fosun Group (SH600196; HK02196). Wanbang Biopharma has been focusing at t...
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : USA
Brand Name : ADMELOG
Dosage Form : SOLUTION;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 1000 UNITS/10ML (100 UNITS/ML)
Packaging :
Approval Date :
Application Number : 209196
Regulatory Info :
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : USA
Brand Name : ADMELOG
Dosage Form : SOLUTION;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 300 UNITS/3ML (100 UNITS/ML)
Packaging :
Approval Date :
Application Number : 209196
Regulatory Info :
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Basal
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Basal
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Finish filled pen, solo star
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Comb 25
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Comb 25 OptiSet
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Rapid
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 IE/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Rapid OptiSet
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 IE/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insulin lispro Sanofi
Dosage Form : Solution for injection in a pre-filled pen
Dosage Strength : 100E/ml
Packaging : Pre-filled pen 5 3ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : ADMELOG
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 3ML CARTRIDGE
Approval Date :
Application Number : 2469898
Regulatory Info : Schedule D
Registration Country : Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD :
TE Code :
Brand Name : ADMELOG
Dosage Form : SOLUTION;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 1000 UNITS/10ML (100 UNITS/ML)
Approval Date :
Application Number : 209196
RX/OTC/DISCN :
RLD :
TE Code :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD :
TE Code :
Brand Name : ADMELOG SOLOSTAR
Dosage Form : SOLUTION;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 300 UNITS/3ML (100 UNITS/ML)
Approval Date :
Application Number : 209196
RX/OTC/DISCN :
RLD :
TE Code :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD :
TE Code :
Brand Name : ADMELOG
Dosage Form : SOLUTION;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 300 UNITS/3ML (100 UNITS/ML)
Approval Date :
Application Number : 209196
RX/OTC/DISCN :
RLD :
TE Code :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Basal
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Basal
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Basal
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Finish filled pen, solo star
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Basal OptiSet
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Comb 25
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Comb 25 OptiSet
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Infusat
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 IE/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Rapid
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 IE/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Rapid
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 IE/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Rapid OptiSet
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 IE/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Originator
Registration Country : South Africa
75% Insulin Lispro Protamine Suspension (Npl)
Brand Name : Humalog Mix25
Dosage Form : PED
Dosage Strength : 100iu/ml
Packaging : 3X5iu/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : HUMALOG 200 units/ml KWIKPEN
Dosage Form : INJ
Dosage Strength : 200u/ml
Packaging : 5X3u/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Humalog
Dosage Form : PED
Dosage Strength : 100iu/ml
Packaging : 3X5iu/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
75% Insulin Lispro Protamine Suspension (Npl)
Brand Name : Humalog Mix 25
Dosage Form : PED
Dosage Strength : 100iu/ml
Packaging : 3X5iu/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : HUMALOG 100 units/ml CARTRIDGE
Dosage Form : CAT
Dosage Strength : 100IU/ml
Packaging : 3X5IU/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Humalog
Dosage Form : SUS
Dosage Strength : 100iu/ml
Packaging : 10X1iu/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
75% Insulin Lispro Protamine Suspension (Npl)
Brand Name : Humalog Mix25
Dosage Form : SUS
Dosage Strength : 100iu/ml
Packaging : 10X1iu/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
75% Insulin Lispro Protamine Suspension (Npl)
Brand Name : Humalog Mix25
Dosage Form : CAT
Dosage Strength : 100iu/ml
Packaging : 3X5iu/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Biosulin R
Dosage Form : INJ
Dosage Strength : 100iu/1ml
Packaging : 5X1iu/1ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Biosulin N
Dosage Form : INJ
Dosage Strength : 100iu/1ml
Packaging : 5X1iu/1ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 300IU/3ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 300IU/3ML
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Related Excipient Companies
Excipients by Applications
Global Sales Information
Main Therapeutic Indication : Diabetes
Currency : USD
2019 Revenue in Millions : 273
2018 Revenue in Millions : 101
Growth (%) : 169
Main Therapeutic Indication : Diabetes
Currency : USD
2018 Revenue in Millions : 105
2017 Revenue in Millions : 0
Growth (%) : NA
Main Therapeutic Indication : Diabetes
Currency : USD
2020 Revenue in Millions : 2,626
2019 Revenue in Millions : 2,821
Growth (%) : -7
Main Therapeutic Indication : Diabetes
Currency : USD
2021 Revenue in Millions : 2,453
2020 Revenue in Millions : 2,626
Growth (%) : -7
Main Therapeutic Indication : Diabetes
Currency : USD
2022 Revenue in Millions : 2,061
2021 Revenue in Millions : 2,453
Growth (%) : -16
Main Therapeutic Indication : Diabetes
Currency : USD
2023 Revenue in Millions : 1,663
2022 Revenue in Millions : 2,061
Growth (%) : -19
Main Therapeutic Indication : Diabetes
Currency : USD
2015 Revenue in Millions : 2,785
2014 Revenue in Millions : 2,842
Growth (%) : 2%
Main Therapeutic Indication : Diabetes
Currency : USD
2014 Revenue in Millions : 6.70%
2013 Revenue in Millions :
Growth (%) :
Main Therapeutic Indication : Diabetes
Currency : USD
2016 Revenue in Millions : 2,769
2015 Revenue in Millions : 2,842
Growth (%) : -3
Main Therapeutic Indication : Diabetes
Currency : USD
2017 Revenue in Millions : 2,865
2016 Revenue in Millions : 2,769
Growth (%) : 3
Market Place
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2015-06-12
Date Granted : 2000-05-09
Brand Name : HUMALOG
Patent Number : 2151560
Filing Date : 1995-06-12
Strength per Unit : 100 U / ml
Dosage Form : Solution for Injection
Human Or VET : Human
Route of Administration : Subcutaneous Injection
Patent Expiration Date : 2015-06-12
Date Granted : 2000-05-09
Patent Expiration Date : 2015-06-12
Date Granted : 2003-02-11
Brand Name : HUMALOG
Patent Number : 2151564
Filing Date : 1995-06-12
Strength per Unit : 100 U / ml
Dosage Form : Solution for Injection
Human Or VET : Human
Route of Administration : Subcutaneous Injection
Patent Expiration Date : 2015-06-12
Date Granted : 2003-02-11
Patent Expiration Date : 2015-06-12
Date Granted : 2000-05-09
Brand Name : HUMALOG
Patent Number : 2151560
Filing Date : 1995-06-12
Strength per Unit : 100 U / ml
Dosage Form : Solution for Injection
Human Or VET : Human
Route of Administration : Subcutaneous Injection
Patent Expiration Date : 2015-06-12
Date Granted : 2000-05-09
Patent Expiration Date : 2015-06-12
Date Granted : 2003-02-11
Brand Name : HUMALOG
Patent Number : 2151564
Filing Date : 1995-06-12
Strength per Unit : 100 U / ml
Dosage Form : Solution for Injection
Human Or VET : Human
Route of Administration : Subcutaneous Injection
Patent Expiration Date : 2015-06-12
Date Granted : 2003-02-11
Patent Expiration Date : 2015-06-12
Date Granted : 2000-05-09
Brand Name : HUMALOG KWIKPEN?
Patent Number : 2151560
Filing Date : 1995-06-12
Strength per Unit : 200 units / mL
Dosage Form : SOLUTION
Human Or VET : Human
Route of Administration : SUBCUTANEOUS
Patent Expiration Date : 2015-06-12
Date Granted : 2000-05-09
Patent Expiration Date : 2018-06-11
Date Granted : 2010-09-14
Brand Name : HUMALOG KWIKPEN?
Patent Number : 2295140
Filing Date : 1998-06-11
Strength per Unit : 200 units / mL
Dosage Form : SOLUTION
Human Or VET : Human
Route of Administration : SUBCUTANEOUS
Patent Expiration Date : 2018-06-11
Date Granted : 2010-09-14
REF. STANDARDS & IMPURITIES
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