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Last Updated: March 19, 2024

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 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
Formulation / Manufacturing:see details
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*:
Constraining patent/regulatory exclusivity:
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

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
Endo Pharm VANTAS histrelin acetate IMPLANT;SUBCUTANEOUS 021732-001 Oct 12, 2004 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Endo Pharm SUPPRELIN LA histrelin acetate IMPLANT;SUBCUTANEOUS 022058-001 May 3, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-003 Dec 24, 1991 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-002 Dec 24, 1991 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-001 Dec 24, 1991 DISCN 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

Expired US Patents for HISTRELIN ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharm SUPPRELIN LA histrelin acetate IMPLANT;SUBCUTANEOUS 022058-001 May 3, 2007 ⤷  Try a Trial ⤷  Try a Trial
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-001 Dec 24, 1991 ⤷  Try a Trial ⤷  Try a Trial
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-002 Dec 24, 1991 ⤷  Try a Trial ⤷  Try a Trial
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-003 Dec 24, 1991 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharm VANTAS histrelin acetate IMPLANT;SUBCUTANEOUS 021732-001 Oct 12, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for HISTRELIN ACETATE

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.