GANIRELIX ACETATE Drug Patent Profile

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Ganirelix Acetate is a drug marketed by Amphastar Pharms Inc, Gland Pharma Ltd, Lupin Ltd, Meitheal, and Organon Usa Organon. and is included in five NDAs.

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

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

US Patents:	0
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	20
Patent Applications:	2,590
Drug Prices:	Drug price information for GANIRELIX ACETATE
What excipients (inactive ingredients) are in GANIRELIX ACETATE?	GANIRELIX ACETATE excipients list
DailyMed Link:	GANIRELIX ACETATE at DailyMed

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

Sponsor	Phase
Yale University	N/A
University of Wisconsin, Madison	Early Phase 1
Casa di Cura Privata Villa Mafalda	Phase 4

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

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

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

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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	⤷ 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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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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	⤷ 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

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

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Country	Patent Number	Title	Estimated Expiration
Denmark	57288		⤷ Try a Trial
Israel	85316	NONA-AND DECAPEPTIDE ANALOGS OF LHRH,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM	⤷ Try a Trial
Hong Kong	35997	Nonapeptide and decapeptide analogs of LHRH as LHRH antagonists	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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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	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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description