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Last Updated: July 27, 2021

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HISTRELIN ACETATE - Generic Drug Details

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What are the generic drug 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 Pharm 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 are two drug master file entries 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: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 28
Clinical Trials: 5
Patent Applications: 6,716
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in HISTRELIN ACETATE?HISTRELIN ACETATE excipients list
DailyMed Link:HISTRELIN ACETATE at DailyMed
Recent Clinical Trials for HISTRELIN ACETATE

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

SponsorPhase
NRG OncologyPhase 3
National Cancer Institute (NCI)Phase 3
Southwest Oncology GroupPhase 3

See all HISTRELIN ACETATE clinical trials

Pharmacology for HISTRELIN ACETATE

US Patents and Regulatory Information for HISTRELIN ACETATE

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-003 Dec 24, 1991 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Endo Pharm VANTAS histrelin acetate IMPLANT;SUBCUTANEOUS 021732-001 Oct 12, 2004 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-001 Dec 24, 1991 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it 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 HISTRELIN ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-002 Dec 24, 1991 ⤷  Try it Free ⤷  Try it Free
Endo Pharm SUPPRELIN LA histrelin acetate IMPLANT;SUBCUTANEOUS 022058-001 May 3, 2007 ⤷  Try it Free ⤷  Try it Free
Endo Pharm VANTAS histrelin acetate IMPLANT;SUBCUTANEOUS 021732-001 Oct 12, 2004 ⤷  Try it Free ⤷  Try it Free
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-001 Dec 24, 1991 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Dow
AstraZeneca
Johnson and Johnson
Medtronic
Express Scripts

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