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ARESTIN Drug Profile
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Which patents cover Arestin, and what generic alternatives are available?
Arestin is a drug marketed by Orapharma and is included in one NDA. There are two patents protecting this drug.
This drug has sixteen patent family members in thirteen countries.
The generic ingredient in ARESTIN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Arestin
A generic version of ARESTIN was approved as minocycline hydrochloride by WATSON LABS on December 30th, 1991.
Summary for ARESTIN
| International Patents: | 16 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 77 |
| Clinical Trials: | 6 |
| Patent Applications: | 1,916 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ARESTIN |
| DailyMed Link: | ARESTIN at DailyMed |
Recent Clinical Trials for ARESTIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bausch Health Companies, INC. | Phase 4 |
| University of Minnesota - Clinical and Translational Science Institute | Phase 4 |
| University of California, San Francisco | N/A |
Pharmacology for ARESTIN
| Drug Class | Tetracycline-class Drug |
US Patents and Regulatory Information for ARESTIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Orapharma | ARESTIN | minocycline hydrochloride | POWDER, EXTENDED RELEASE;DENTAL | 050781-001 | Feb 16, 2001 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Orapharma | ARESTIN | minocycline hydrochloride | POWDER, EXTENDED RELEASE;DENTAL | 050781-001 | Feb 16, 2001 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ARESTIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4749672 | Start Trial |
| Canada | 2479995 | Start Trial |
| Argentina | 039205 | Start Trial |
| Denmark | 2263596 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
