TREXALL Drug Patent Profile
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Which patents cover Trexall, and what generic alternatives are available?
Trexall is a drug marketed by Barr and is included in one NDA.
The generic ingredient in TREXALL is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Trexall
A generic version of TREXALL was approved as methotrexate sodium by HIKMA on September 16th, 1986.
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Questions you can ask:
- What is the 5 year forecast for TREXALL?
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- What is Average Wholesale Price for TREXALL?
Summary for TREXALL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 137 |
| Clinical Trials: | 44 |
| Patent Applications: | 4,326 |
| DailyMed Link: | TREXALL at DailyMed |
Recent Clinical Trials for TREXALL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| OncoImmune, Inc. | Phase 3 |
| Indiana University School of Medicine | Phase 3 |
| University of Michigan Rogel Cancer Center | Phase 3 |
Pharmacology for TREXALL
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
US Patents and Regulatory Information for TREXALL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Barr | TREXALL | methotrexate sodium | TABLET;ORAL | 040385-001 | Mar 21, 2001 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Barr | TREXALL | methotrexate sodium | TABLET;ORAL | 040385-004 | Mar 21, 2001 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Barr | TREXALL | methotrexate sodium | TABLET;ORAL | 040385-002 | Mar 21, 2001 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Barr | TREXALL | methotrexate sodium | TABLET;ORAL | 040385-003 | Mar 21, 2001 | RX | No | 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 |
