Histrelin acetate - Generic Drug Details

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What are the generic sources for histrelin acetate and what is the scope of freedom to operate?

Histrelin acetate is the generic ingredient in three branded drugs marketed by Endo Operations and Shire, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Histrelin acetate has three patent family members in three countries.

There is one drug master file entry for histrelin acetate. One supplier is listed for this compound.

Summary for histrelin acetate

International Patents:	3
US Patents:	1
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	5
Patent Applications:	6,655
What excipients (inactive ingredients) are in histrelin acetate?	histrelin acetate excipients list
DailyMed Link:	histrelin acetate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for histrelin acetate

Generic Entry Date for histrelin acetate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: IMPLANT;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for histrelin acetate

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

Sponsor	Phase
NRG Oncology	Phase 3
National Cancer Institute (NCI)	Phase 3
Southwest Oncology Group	Phase 3

See all histrelin acetate clinical trials

Pharmacology for histrelin acetate

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for histrelin acetate

L02AE	Gonadotropin releasing hormone analogues
L02A	HORMONES AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for histrelin 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
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-002	Dec 24, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	VANTAS	histrelin acetate	IMPLANT;SUBCUTANEOUS	021732-001	Oct 12, 2004		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-001	Dec 24, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007		RX	Yes	Yes	⤷ 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 histrelin acetate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007	⤷ Sign Up	⤷ Sign Up
Endo Operations	VANTAS	histrelin acetate	IMPLANT;SUBCUTANEOUS	021732-001	Oct 12, 2004	⤷ Sign Up	⤷ Sign Up
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-001	Dec 24, 1991	⤷ Sign Up	⤷ Sign Up
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-003	Dec 24, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for histrelin acetate

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1773293	COMPOSITIONS ET METHODES DE TRAITEMENT DE LA PUBERTE CENTRALE PRECOCE (COMPOSITIONS AND METHODS FOR TREATING CENTRAL PRECOCIOUS PUBERTY)	⤷ Sign Up
Canada	2570960	COMPOSITIONS ET METHODES DE TRAITEMENT DE LA PUBERTE CENTRALE PRECOCE (COMPOSITIONS AND METHODS FOR TREATING CENTRAL PRECOCIOUS PUBERTY)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006009801		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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