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Last Updated: June 28, 2022

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 Amphastar Pharms Inc, Organon Usa Inc, and Sun Pharm, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for ganirelix acetate
US Patents:0
Tradenames:1
Applicants:3
NDAs:3
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 42
Clinical Trials: 20
Patent Applications: 6,516
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
Yale UniversityN/A
University of Wisconsin, MadisonEarly Phase 1
Casa di Cura Privata Villa MafaldaPhase 4

See all ganirelix acetate clinical trials

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
Sun Pharm GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 204246-001 Nov 30, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amphastar Pharms Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 212613-001 Apr 7, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 See Plans and Pricing See Plans and Pricing
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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