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Last Updated: July 28, 2021

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GANIRELIX ACETATE Drug Patent Profile


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Which patents cover Ganirelix Acetate, and what generic alternatives are available?

Ganirelix Acetate is a drug marketed by Organon Usa Inc and Sun Pharm and is included in two NDAs.

The generic ingredient in GANIRELIX ACETATE is ganirelix acetate. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ganirelix acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ganirelix Acetate

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

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Summary for GANIRELIX ACETATE
US Patents:0
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 26
Clinical Trials: 17
Patent Applications: 2,933
What excipients (inactive ingredients) are in GANIRELIX ACETATE?GANIRELIX ACETATE excipients list
DailyMed Link:GANIRELIX ACETATE at DailyMed
Drug patent expirations by year for GANIRELIX ACETATE
Recent Clinical Trials for GANIRELIX ACETATE

Identify potential brand extensions & 505(b)(2) entrants

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

See all GANIRELIX ACETATE clinical trials

Paragraph IV (Patent) Challenges for GANIRELIX ACETATE
Tradename Dosage Ingredient NDA Submissiondate
GANIRELIX ACETATE INJECTABLE;INJECTION ganirelix acetate 021057 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
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 AP RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sun Pharm GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 204246-001 Nov 30, 2018 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ⤷  Free Forever Trial ⤷  Free Forever Trial
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ⤷  Free Forever Trial ⤷  Free Forever Trial
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for GANIRELIX ACETATE

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

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Serving leading biopharmaceutical companies globally:

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Colorcon
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.