METHOTREXATE PRESERVATIVE FREE Drug Patent Profile
When do Methotrexate Preservative Free patents expire, and when can generic versions of Methotrexate Preservative Free launch?
Methotrexate Preservative Free is a drug marketed by Fresenius Kabi Usa and Hospira and is included in three NDAs.
The generic ingredient in METHOTREXATE PRESERVATIVE FREE is methotrexate sodium. There is one drug master file entry for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Methotrexate Preservative Free
A generic version of METHOTREXATE PRESERVATIVE FREE was approved as methotrexate sodium by HIKMA on September 16th, 1986.
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Summary for METHOTREXATE PRESERVATIVE FREE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 2 |
| DailyMed Link: | METHOTREXATE PRESERVATIVE FREE at DailyMed |
Recent Clinical Trials for METHOTREXATE PRESERVATIVE FREE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aaron Boster | Early Phase 1 |
| Pfizer | Early Phase 1 |
| EMD Serono | Early Phase 1 |
Pharmacology for METHOTREXATE PRESERVATIVE FREE
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
US Patents and Regulatory Information for METHOTREXATE PRESERVATIVE FREE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | METHOTREXATE PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040266-001 | Feb 26, 1999 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hospira | METHOTREXATE PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 011719-014 | Apr 13, 2005 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Fresenius Kabi Usa | METHOTREXATE PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040265-001 | Feb 26, 1999 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
