AZULFIDINE Drug Patent Profile
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When do Azulfidine patents expire, and when can generic versions of Azulfidine launch?
Azulfidine is a drug marketed by Pharmacia And Upjohn and Pfizer and is included in two NDAs.
The generic ingredient in AZULFIDINE is sulfasalazine. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Azulfidine
A generic version of AZULFIDINE was approved as sulfasalazine by WATSON LABS on December 31st, 1969.
Summary for AZULFIDINE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 142 |
| Clinical Trials: | 4 |
| Patent Applications: | 4,233 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AZULFIDINE |
| What excipients (inactive ingredients) are in AZULFIDINE? | AZULFIDINE excipients list |
| DailyMed Link: | AZULFIDINE at DailyMed |
Recent Clinical Trials for AZULFIDINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Erlangen-Nürnberg Medical School | Phase 3 |
| Columbia University | Phase 4 |
| Brigham and Women's Hospital | Phase 4 |
Pharmacology for AZULFIDINE
| Drug Class | Aminosalicylate |
Anatomical Therapeutic Chemical (ATC) Classes for AZULFIDINE
US Patents and Regulatory Information for AZULFIDINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmacia And Upjohn | AZULFIDINE | sulfasalazine | SUSPENSION;ORAL | 018605-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer | AZULFIDINE | sulfasalazine | TABLET;ORAL | 007073-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Pfizer | AZULFIDINE EN-TABS | sulfasalazine | TABLET, DELAYED RELEASE;ORAL | 007073-002 | Apr 6, 1983 | AB | RX | Yes | Yes | ⤷ 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 |
