Aminosalicylic acid - Generic Drug Details
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What are the generic drug sources for aminosalicylic acid and what is the scope of freedom to operate?
Aminosalicylic acid
is the generic ingredient in three branded drugs marketed by Eurocept Pharms, Panray, and Bristol Myers Squibb, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for aminosalicylic acid.
Summary for aminosalicylic acid
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 151 |
| Clinical Trials: | 28 |
| Patent Applications: | 6,610 |
| What excipients (inactive ingredients) are in aminosalicylic acid? | aminosalicylic acid excipients list |
| DailyMed Link: | aminosalicylic acid at DailyMed |
Recent Clinical Trials for aminosalicylic acid
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tanta University | Early Phase 1 |
| Assistance Publique - Hôpitaux de Paris | Phase 1/Phase 2 |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences | Phase 2 |
Medical Subject Heading (MeSH) Categories for aminosalicylic acid
US Patents and Regulatory Information for aminosalicylic acid
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | REZIPAS | aminosalicylic acid resin complex | POWDER;ORAL | 009052-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Panray | PARASAL | aminosalicylic acid | TABLET;ORAL | 006811-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Panray | PARASAL | aminosalicylic acid | TABLET;ORAL | 006811-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eurocept Pharms | PASER | aminosalicylic acid | GRANULE, DELAYED RELEASE;ORAL | 074346-001 | Jun 30, 1994 | RX | No | Yes | ⤷ 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 |
