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Weekly News Recap #Phispers
1. Kisqali
2. Lee011
3. Ribociclib
1. Lee011 Succinate
2. 1374639-75-4
3. Lee-011 Succinate
4. Lee011-bba
5. Ribociclib Succinate [usan]
6. Kisqali
7. Lee-011-bba
8. Bg7hlx2919
9. 7-cyclopentyl-n,n-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide Succinate
10. Butanedioic Acid;7-cyclopentyl-n,n-dimethyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino]pyrrolo[2,3-d]pyrimidine-6-carboxamide
11. Ribociclib Succinate (usan)
12. Butanedioic Acid, Compd. With 7-cyclopentyl-n,n-dimethyl-2-((5-(1-piperazinyl)-2-pyridinyl)amino)-7h-pyrrolo(2,3-d)pyrimidine-6-carboxamide (1:1)
13. Butanedioic Acid, Compd. With 7-cyclopentyl-n,n-dimethyl-2-[[5-(1-piperazinyl)-2-pyridinyl]amino]-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1:1)
14. Unii-bg7hlx2919
15. Kisqali (tn)
16. Lee011 (succinate)
17. Birociclib [who-dd]
18. Schembl2684999
19. Chembl3707266
20. Ribociclib Succinate [mi]
21. Dtxsid301027923
22. Amy25508
23. Bcp12715
24. Ex-a1586
25. Zec63975
26. Lee011 Succinatelee011 Succinate
27. Hy-15777b
28. S5188
29. Ribociclib Succinate [who-dd]
30. Sb18482
31. Ac-30654
32. As-75241
33. Ribociclib Succinate [orange Book]
34. D10979
35. Lee-011 Succinate Salt, Ribociclib Succinate Salt
36. J-007026
37. Q27274660
38. Kisqali Femara Co-pack Component Ribociclib Succinate
39. Ribociclib Succinate Component Of Kisqali Femara Co-pack
40. 7-cyclopentyl-n,n-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide; Butanedioic Acid
Molecular Weight | 552.6 g/mol |
---|---|
Molecular Formula | C27H36N8O5 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 8 |
Exact Mass | 552.28086628 g/mol |
Monoisotopic Mass | 552.28086628 g/mol |
Topological Polar Surface Area | 166 Ų |
Heavy Atom Count | 40 |
Formal Charge | 0 |
Complexity | 728 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
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 | KISQALI |
Active Ingredient | RIBOCICLIB SUCCINATE |
Company | NOVARTIS PHARMS CORP (Application Number: N209092. Patents: 8324225, 8415355, 8685980, 8962630, 9193732, 9416136, 9868739) |
2 of 2 | |
---|---|
Drug Name | KISQALI FEMARA CO-PACK (COPACKAGED) |
Active Ingredient | LETROZOLE; RIBOCICLIB SUCCINATE |
Company | NOVARTIS PHARMS CORP (Application Number: N209935. Patents: 8324225, 8415355, 8685980, 8962630, 9193732, 9416136, 9868739) |
Kisqali is indicated for the treatment of women with hormone receptor (HR)positive, human epidermal growth factor receptor 2 (HER2)negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
In pre or perimenopausal women, the endocrine therapy should be combined with a luteinising hormonereleasing hormone (LHRH) agonist.
L01XE
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36174
Submission : 2021-11-30
Status : Active
Type : II
NDC Package Code : 52076-6203
Start Marketing Date : 2017-09-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-22
Pay. Date : 2020-10-09
DMF Number : 35288
Submission : 2020-11-26
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-18
Pay. Date : 2021-09-24
DMF Number : 36335
Submission : 2021-09-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-03
Pay. Date : 2020-09-25
DMF Number : 35098
Submission : 2020-09-01
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0101
Start Marketing Date : 2020-08-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35027
Submission : 2020-09-10
Status : Inactive
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36174
Submission : 2021-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35027
Submission : 2020-09-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-18
Pay. Date : 2021-09-24
DMF Number : 36335
Submission : 2021-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-03
Pay. Date : 2020-09-25
DMF Number : 35098
Submission : 2020-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-22
Pay. Date : 2020-10-09
DMF Number : 35288
Submission : 2020-11-26
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm : API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, G...
Date of Issue : 2021-10-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0082A11
Address of the Firm : API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, G...
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm : MIs. MSN Laboratories Private Limited, Unit-II, sv. No, 50, Kardanur (Village), ...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC Package Code : 52076-6261
Start Marketing Date : 2018-10-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC Package Code : 52076-6203
Start Marketing Date : 2017-09-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 54893-0101
Start Marketing Date : 2020-08-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 63592-1600
Start Marketing Date : 2020-09-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65344-0036
Start Marketing Date : 2021-09-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 81955-0003
Start Marketing Date : 2017-03-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
About the Company : Arevipharma GmbH is a modern manufacturer of active pharmaceutical ingredients and intermediates with more than 140 years of expertise. Our customers are generic and research-based...
About the Company : Cdymax (India) Pharma Private Limited was founded in 1994. The company's line of business includes the manufacturing, fabricating, or processing of drugs in pharmaceutical preparat...
About the Company : Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was fou...
About the Company : Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission i...
About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...
About the Company : NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 e...
About the Company : Teva API is a standalone business unit within Teva Pharmaceutical Industries, the world’s largest generic drug manufacturer. Employing over 4,000 professionals at 15 internationa...
RLD :
TE Code :
Brand Name : RIBOCICLIB
Dosage Form : TABLET; ORAL
Dosage Strength : 200MG
Approval Date :
Application Number : 215677
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : KISQALI
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 200MG BASE
Approval Date : 2017-03-13
Application Number : 209092
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
LETROZOLE; RIBOCICLIB SUCCINATE
Brand Name : KISQALI FEMARA CO-PACK (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 2.5MG;EQ 200MG BASE
Approval Date : 2017-05-04
Application Number : 209935
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Switzerland
Brand Name : Kisqali
Dosage Form : Tabl
Dosage Strength : 200mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Kisqali
Dosage Form : Tabl
Dosage Strength : 200mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Kisqali
Dosage Form : Tabl
Dosage Strength : 200mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Kisqali
Dosage Form :
Dosage Strength :
Packaging : 21
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Kisqali
Dosage Form :
Dosage Strength :
Packaging : 63
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Kisqali
Dosage Form :
Dosage Strength :
Packaging : 42
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : KRYXANA 200MG
Dosage Form : FCT
Dosage Strength : 200mg
Packaging : 21X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 200MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Hungary
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2030-05-25
LETROZOLE; RIBOCICLIB SUCCINATE
US Patent Number : 8685980
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 209935
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-05-25
Patent Expiration Date : 2029-12-09
LETROZOLE; RIBOCICLIB SUCCINATE
US Patent Number : 8962630
Drug Substance Claim :
Drug Product Claim :
Application Number : 209935
Patent Use Code : U-2505
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-09
Patent Expiration Date : 2031-03-13
LETROZOLE; RIBOCICLIB SUCCINATE
US Patent Number : 8415355
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 209935
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-03-13
Patent Expiration Date : 2029-12-09
LETROZOLE; RIBOCICLIB SUCCINATE
US Patent Number : 8962630
Drug Substance Claim :
Drug Product Claim :
Application Number : 209935
Patent Use Code : U-3264
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-09
Patent Expiration Date : 2036-04-14
LETROZOLE; RIBOCICLIB SUCCINATE
US Patent Number : 12064434
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 209935
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2036-04-14
Patent Expiration Date : 2029-08-20
LETROZOLE; RIBOCICLIB SUCCINATE
US Patent Number : 9416136
Drug Substance Claim :
Drug Product Claim :
Application Number : 209935
Patent Use Code : U-2505
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-08-20
Exclusivity Code : NPP
Exclusivity Expiration Date : 2024-12-10
Application Number : 209092
Product Number : 1
Exclusivity Details :
Exclusivity Code : I-950
Exclusivity Expiration Date : 2027-09-17
Application Number : 209092
Product Number : 1
Exclusivity Details :
LETROZOLE; RIBOCICLIB SUCCINATE
Exclusivity Code : NPP
Exclusivity Expiration Date : 2024-12-10
Application Number : 209935
Product Number : 1
Exclusivity Details :
LETROZOLE; RIBOCICLIB SUCCINATE
Exclusivity Code : I-951
Exclusivity Expiration Date : 2027-09-17
Application Number : 209935
Product Number : 1
Exclusivity Details :
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