SUBUTEX Drug Patent Profile
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Which patents cover Subutex, and what generic alternatives are available?
Subutex is a drug marketed by Indivior and is included in one NDA.
The generic ingredient in SUBUTEX is buprenorphine hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Subutex
A generic version of SUBUTEX was approved as buprenorphine hydrochloride by HOSPIRA on June 3rd, 1996.
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Questions you can ask:
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Summary for SUBUTEX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 30 |
| Clinical Trials: | 39 |
| Patent Applications: | 2 |
| DailyMed Link: | SUBUTEX at DailyMed |
Recent Clinical Trials for SUBUTEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The Emmes Company, LLC | Phase 3 |
| T. John Winhusen, PhD | Phase 3 |
| The EMMES Corporation | Phase 3 |
US Patents and Regulatory Information for SUBUTEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indivior | SUBUTEX | buprenorphine hydrochloride | TABLET;SUBLINGUAL | 020732-002 | Oct 8, 2002 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Indivior | SUBUTEX | buprenorphine hydrochloride | TABLET;SUBLINGUAL | 020732-003 | Oct 8, 2002 | DISCN | Yes | No | ⤷ 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 |
