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Generated: June 28, 2017
What are the generic drug sources for methotrexate sodium and what is the scope of methotrexate sodium freedom to operate?
Methotrexate sodium is the generic ingredient in twelve branded drugs marketed by Silvergate Pharms, Zydus Pharms Usa Inc, Accord Hlthcare, Hospira, Abraxis Pharm, Mylan Labs Ltd, Sandoz Inc, West-ward Pharms Int, Duramed Pharms Barr, Mylan, Pharmacia And Upjohn, Pharmachemie Bv, Norbrook, Hq Spclt Pharma, Abic, Pharmachemie Usa, Bristol, Bristol Myers, Fresenius Kabi Usa, Dava Pharms Inc, Barr, and Bristol Myers Squibb, and is included in forty-five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 12 |
| Patents: | 2 |
| Applicants: | 22 |
| NDAs: | 45 |
| Drug Master File Entries: see list | 20 |
| Suppliers / Packagers: see list | 26 |
| Bulk Api Vendors: see list | 105 |
| Clinical Trials: see list | 3,843 |
| Patent Applications: see list | 9,855 |
| Therapeutic Class: | Immunological Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | methotrexate sodium at DailyMed |
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
West-ward Pharms Int | METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 089342-001 | Sep 16, 1986 | RX | No | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Mylan Labs Ltd | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 201530-001 | Mar 29, 2012 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Pharmacia And Upjohn | FOLEX | methotrexate sodium | INJECTABLE;INJECTION | 088954-001 | Oct 24, 1985 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Duramed Pharms Barr | METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 040233-001 | Jun 17, 1999 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Pharmachemie Bv | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040843-004 | Jan 11, 2010 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United Kingdom | 201200192 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2614814 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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