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Last Updated: June 14, 2021

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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 freedom to operate?

Ganirelix acetate is the generic ingredient in one branded drug marketed by Organon Usa Inc and Sun Pharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for ganirelix acetate
US Patents:0
Tradenames:1
Applicants:2
NDAs:2
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 26
Clinical Trials: 17
Patent Applications: 5,779
What excipients (inactive ingredients) are in ganirelix acetate?ganirelix acetate excipients list
DailyMed Link:ganirelix acetate at DailyMed
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

Pharmacology for ganirelix acetate
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   Get Started Free   Get Started Free   Get Started Free
Sun Pharm GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 204246-001 Nov 30, 2018 AP RX No No   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free   Get Started Free
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999   Get Started Free   Get Started Free
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
McKesson
Merck
AstraZeneca
Dow

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