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Last Updated: March 29, 2024

GANIRELIX ACETATE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Ganirelix Acetate

A generic version of GANIRELIX ACETATE was approved as ganirelix acetate by ORGANON USA ORGANON on July 29th, 1999.

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Summary for GANIRELIX ACETATE
Drug patent expirations by year for GANIRELIX ACETATE
Drug Prices for GANIRELIX ACETATE

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Recent Clinical Trials for GANIRELIX ACETATE

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SponsorPhase
Yale UniversityN/A
University of Wisconsin, MadisonEarly Phase 1
Casa di Cura Privata Villa MafaldaPhase 4

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Pharmacology for GANIRELIX ACETATE
Paragraph IV (Patent) Challenges for GANIRELIX ACETATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GANIRELIX ACETATE Injection ganirelix acetate 250 mcg/0.5 mL, 1 mL PFS 021057 1 2012-03-30

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
Amphastar Pharms Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 212613-001 Apr 7, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 214996-001 Jun 6, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 215658-001 Feb 28, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 216075-001 Nov 16, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon Usa Organon GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for GANIRELIX ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Organon GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ⤷  Try a Trial ⤷  Try a Trial
Organon Usa Organon GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ⤷  Try a Trial ⤷  Try a Trial
Organon Usa Organon GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for GANIRELIX ACETATE

See the table below for patents covering GANIRELIX ACETATE around the world.

Country Patent Number Title Estimated Expiration
Japan S63201199 NONAPEPTIDE OF LHRH USEFUL AS LHRH ANTAGONIST AND DECAPEPTIDE ANALOGUE ⤷  Try a Trial
Spain 2247710 ⤷  Try a Trial
Hungary T63855 ⤷  Try a Trial
Denmark 57288 ⤷  Try a Trial
South Africa 8800795 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GANIRELIX ACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0277829 SPC/GB00/024 United Kingdom ⤷  Try a Trial PRODUCT NAME: GANIRELIX OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/130/001 20000517; UK EU/1/00/130/002 20000517
0277829 27/2000 Austria ⤷  Try a Trial PRODUCT NAME: GANIRELIX ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517
0277829 2000C/030 Belgium ⤷  Try a Trial PRODUCT NAME: GANIRELIX; REGISTRATION NO/DATE: EU/1/00/130/001 20000518
0277829 C300016 Netherlands ⤷  Try a Trial PRODUCT NAME: GANIRELIX, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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