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 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
Sponsor | Phase |
---|---|
NRG Oncology | Phase 3 |
Southwest Oncology Group | Phase 3 |
National Cancer Institute (NCI) | Phase 3 |
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
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 | 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 | 019836-002 | Dec 24, 1991 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Endo Pharm | VANTAS | histrelin acetate | IMPLANT;SUBCUTANEOUS | 021732-001 | Oct 12, 2004 | DISCN | Yes | 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 | 019836-002 | Dec 24, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
Endo Pharm | SUPPRELIN LA | histrelin acetate | IMPLANT;SUBCUTANEOUS | 022058-001 | May 3, 2007 | ⤷ 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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