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Julphar
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McKinsey
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Federal Trade Commission
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Boehringer Ingelheim
Medtronic
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Generated: January 18, 2019

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Ganirelix acetate - Generic Drug Details

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What are the generic drug sources for ganirelix acetate and what is the scope of ganirelix acetate patent protection?

Ganirelix acetate is the generic ingredient in one branded drug marketed by Organon Usa Inc and Sun Pharm Inds Ltd, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ganirelix acetate has seven patent family members in seven countries.

There are four drug master file entries for ganirelix acetate. Two suppliers are listed for this compound.

Pharmacology for ganirelix acetate
Synonyms for ganirelix acetate
123246-29-7
124904-93-4
129311-55-3
311G553
56U7906FQW
Ac-D-Nal-[D-(pCl)Phe]-D-Pal-Ser-Tyr-D-Har(Et2)-Leu-Har(Et2)-Pro-DAla-NH2
AKOS025394292
AM013800
Antagon
BC252406
BDBM50102454
CHEBI:135910
CHEMBL1251
CTK8E7074
D-Alaninamide, N-acetyl-3-(1-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-L-tyrosyl-N6-(bis(ethylamino)methylene)-D-lysyl-L-leucyl-N6-(bis(ethylamino)methylene)-L-lysyl-L-prolyl-
D-Alaninamide, N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-L-tyrosyl-N(sup 6)-((ethylamino)(ethylimino)methyl)-D-lysyl-L-leucyl-N(sup 6)-((ethylamino)(ethylimino)methyl)-L-lys
D04302
D08010
DB06785
Ganirelix
Ganirelix (INN)
Ganirelix acetate (JAN/USAN)
Ganirelix acetate [USAN]
Ganirelix Acetate Injection
Ganirelix acetate injection (TN)
Ganirelixum
Ganirest (TN)
GJNXBNATEDXMAK-PFLSVRRQSA-N
IX503L9WN0
J-005666
LS-187280
N-Acetyl-3-(2-naphthyl)-D-alanyl-p-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N(sup 6)-(N,N'-diethylamidino)-D-lysyl-L-leucyl-N(sup 6)-(N,N'-diethylamidino)-L-lysyl-L-prolyl-D-alaninamide diacetate (salt)
Org-37462
Orgalutran
Orgalutran (TN)
RS-26306
RT-013079
SCHEMBL19712192
UNII-56U7906FQW
UNII-IX503L9WN0
Y-100038

US Patents and Regulatory Information for ganirelix acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Ltd GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 204246-001 Nov 30, 2018 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ganirelix acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ➤ Sign Up ➤ Sign Up
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ➤ Sign Up ➤ Sign Up
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ganirelix acetate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00016 Netherlands ➤ Sign Up PRODUCT NAME: GANIRELIX, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517
/2000 Austria ➤ Sign Up PRODUCT NAME: GANIRELIX ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517
C/GB00/024 United Kingdom ➤ Sign Up PRODUCT NAME: GANIRELIX OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/130/001 20000517; UK EU/1/00/130/002 20000517
00C/030 Belgium ➤ Sign Up PRODUCT NAME: GANIRELIX; REGISTRATION NO/DATE: EU/1/00/130/001 20000518
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Argus Health
Moodys
US Department of Justice
Daiichi Sankyo
Mallinckrodt
Deloitte
Fuji
Healthtrust

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