DIFLUNISAL Drug Patent Profile
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When do Diflunisal patents expire, and what generic alternatives are available?
Diflunisal is a drug marketed by Ani Pharms, Dastech Intl, Heritage Pharma, Purepac Pharm, Teva, Watson Labs, and Zydus Pharms. and is included in nine NDAs.
The generic ingredient in DIFLUNISAL is diflunisal. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the diflunisal profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Diflunisal
A generic version of DIFLUNISAL was approved as diflunisal by TEVA on July 31st, 1992.
Summary for DIFLUNISAL
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 120 |
| Clinical Trials: | 6 |
| Patent Applications: | 3,272 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DIFLUNISAL |
| DailyMed Link: | DIFLUNISAL at DailyMed |
See drug prices for DIFLUNISAL
Recent Clinical Trials for DIFLUNISAL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bristol-Myers Squibb | Phase 1 |
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Pharmacology for DIFLUNISAL
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for DIFLUNISAL
Anatomical Therapeutic Chemical (ATC) Classes for DIFLUNISAL
US Patents and Regulatory Information for DIFLUNISAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | DIFLUNISAL | diflunisal | TABLET;ORAL | 074604-001 | Jun 10, 1996 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Teva | DIFLUNISAL | diflunisal | TABLET;ORAL | 073679-001 | Jul 31, 1992 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Heritage Pharma | DIFLUNISAL | diflunisal | TABLET;ORAL | 202845-001 | Mar 8, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva | DIFLUNISAL | diflunisal | TABLET;ORAL | 073673-001 | Jul 31, 1992 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dastech Intl | DIFLUNISAL | diflunisal | TABLET;ORAL | 073562-001 | Nov 27, 1992 | 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 |
