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 two branded drugs marketed by Sun Pharm, Amphastar Pharms Inc, Gland Pharma Ltd, Lupin Ltd, Meitheal, and Organon Usa Organon, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for ganirelix acetate

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	22
Patent Applications:	295
Drug Prices:	Drug price trends for ganirelix acetate
What excipients (inactive ingredients) are in ganirelix acetate?	ganirelix acetate excipients list
DailyMed Link:	ganirelix acetate at DailyMed

See drug prices for ganirelix acetate

Recent Clinical Trials for ganirelix acetate

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

Sponsor	Phase
Instituto Bernabeu	Phase 4
Jiangsu HengRui Medicine Co., Ltd.	Phase 3
Yale University	N/A

See all ganirelix acetate clinical trials

Pharmacology for ganirelix acetate

Drug Class	Gonadotropin Releasing Hormone Receptor Antagonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Antagonists
Physiological Effect	Decreased GnRH Secretion

Anatomical Therapeutic Chemical (ATC) Classes for ganirelix acetate

H01CC	Anti-gonadotropin-releasing hormones
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organon Usa Organon	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	021057-001	Jul 29, 1999	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	215658-001	Feb 28, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	FYREMADEL	ganirelix acetate	INJECTABLE;INJECTION	204246-001	Nov 30, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

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