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Generated: September 26, 2018

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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 is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for ganirelix acetate. One supplier is 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 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for ganirelix acetate

Country Document Number Estimated Expiration
European Patent Office 0994718 ➤ Try a Free Trial
Denmark 0994718 ➤ Try a Free Trial
Austria 302018 ➤ Try a Free Trial
World Intellectual Property Organization (WIPO) 9858657 ➤ Try a Free Trial
Germany 69831241 ➤ Try a Free Trial
Spain 2247710 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for ganirelix acetate

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

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Cerilliant
US Army
Moodys
Baxter
Covington
Johnson and Johnson
Medtronic
Accenture

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