Synopsis
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1. 74381-53-6
2. Leuprorelin Acetate;h-pyr-his-trp-ser-tyr-d-leu-leu-arg-pro-nhet.ch3co2h
3. Lupron (tn)
4. Mfcd00072080
5. Fensolvi (tn)
6. Eligard (tn)
7. Lutrate (tn)
8. Leuprolide Acetate (usp)
9. Leuprorelin Acetate (jp17)
10. Schembl1651429
11. 5-oxopro-his-trp-ser-tyr-d-leu-leu-arg-pronhc2h5 Dihydrate
12. Amy12301
13. Nsc746847
14. Nsc-746847
15. Sy225936
16. Ft-0627807
17. D00989
18. Leuprorelin Acetate; Lupron; Leuprolide Acetate
Molecular Weight | 1269.4 g/mol |
---|---|
Molecular Formula | C61H88N16O14 |
Hydrogen Bond Donor Count | 16 |
Hydrogen Bond Acceptor Count | 16 |
Rotatable Bond Count | 32 |
Exact Mass | 1268.66659154 g/mol |
Monoisotopic Mass | 1268.66659154 g/mol |
Topological Polar Surface Area | 469 Ų |
Heavy Atom Count | 91 |
Formal Charge | 0 |
Complexity | 2420 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 9 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Leuprolide acetate |
Drug Label | Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-s... |
Active Ingredient | Leuprolide acetate |
Dosage Form | Injectable |
Route | Injection |
Strength | 1mg/0.2ml |
Market Status | Prescription |
Company | Teva Pharms Usa; Sandoz; Sun Pharma Global |
2 of 2 | |
---|---|
Drug Name | Leuprolide acetate |
Drug Label | Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-s... |
Active Ingredient | Leuprolide acetate |
Dosage Form | Injectable |
Route | Injection |
Strength | 1mg/0.2ml |
Market Status | Prescription |
Company | Teva Pharms Usa; Sandoz; Sun Pharma Global |
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-02
Pay. Date : 2016-04-29
DMF Number : 13822
Submission : 1998-11-06
Status : Active
Type : II
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 : 14440
Submission : 1999-10-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-29
Pay. Date : 2020-11-09
DMF Number : 28808
Submission : 2014-11-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15189
Submission : 2000-12-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6142
Submission : 1985-12-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10416
Submission : 1993-08-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4476
Submission : 1982-01-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9365
Submission : 1991-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7021
Submission : 1987-06-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11395
Submission : 1995-03-24
Status : Active
Type : II
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Global Sales Information
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 7.5MG
Price Per Pack :
Published in :
Country : USA
RX/OTC/DISCN : RX
Dosage Form : Powder and liquid to the injecti...
Dosage Strength : 11.25 mg
Price Per Pack (Euro) : 320.20
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Dry Sub
Dosage Strength : 3.75mg
Price Per Pack (Euro) : 123.67
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Dry Sub
Dosage Strength : 11.25mg
Price Per Pack (Euro) : 360.01
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Dry Sub
Dosage Strength : 30mg
Price Per Pack (Euro) : 930.57
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 11.25MG
Price Per Pack :
Published in :
Country : USA
RX/OTC/DISCN : RX
Dosage Form : Powder and liquid to the injecti...
Dosage Strength : 11.25 mg
Price Per Pack (Euro) : 320.20
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Powder and liquid to the injecti...
Dosage Strength : 3.75 mg
Price Per Pack (Euro) : 148.01
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Powder and liquid to the injecti...
Dosage Strength : 3.75 mg
Price Per Pack (Euro) : 434.53
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Powder and liquid to the injecti...
Dosage Strength : 30 mg
Price Per Pack (Euro) : 635.66
Published in :
Country : Norway
RX/OTC/DISCN :
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2031-02-05
US Patent Number : 8921326
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 20263
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-02-05
Patent Expiration Date : 2028-03-22
US Patent Number : 9617303
Drug Substance Claim :
Drug Product Claim :
Application Number : 20517
Patent Use Code : U-4001
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-03-22
Patent Expiration Date : 2028-03-22
US Patent Number : 9617303
Drug Substance Claim :
Drug Product Claim :
Application Number : 20263
Patent Use Code : U-3611
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-03-22
Patent Expiration Date : 2031-02-05
US Patent Number : 8921326
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 20517
Patent Use Code : U-1666
Delist Requested :
Patent Use Description : PALLIATIVE TREATMENT O...
Patent Expiration Date : 2031-02-05
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