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Methotrexate sodium - Generic Drug Details
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What are the generic sources for methotrexate sodium and what is the scope of freedom to operate?
Methotrexate sodium
is the generic ingredient in twelve branded drugs marketed by Abic, Pharmacia And Upjohn, Hospira, Fresenius Kabi Usa, Abraxis Pharm, Norbrook, Pharmachemie Usa, West-ward Pharms Int, Accord Hlthcare, Mylan Labs Ltd, Pharmachemie Bv, Sagent Pharms Inc, Sandoz Inc, Bristol, Bristol Myers, Bristol Myers Squibb, Azurity, Amneal Pharms, Barr, Dava Pharms Inc, Duramed Pharms Barr, Eugia Pharma, Hikma, Mylan, Sun Pharm, and Zydus Pharms, and is included in forty-nine NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Methotrexate sodium has three patent family members in three countries.
There are twenty drug master file entries for methotrexate sodium.
Summary for methotrexate sodium
| International Patents: | 3 |
| US Patents: | 4 |
| Tradenames: | 12 |
| Applicants: | 26 |
| NDAs: | 49 |
| Drug Master File Entries: | 20 |
| Bulk Api Vendors: | 33 |
| Clinical Trials: | 23 |
| Patent Applications: | 7,227 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | methotrexate sodium at DailyMed |
Recent Clinical Trials for methotrexate sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Zhongda Hospital | Phase 4 |
| National Institute for Health Research, United Kingdom | Phase 4 |
| University of Oxford | Phase 4 |
Pharmacology for methotrexate sodium
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
US Patents and Regulatory Information for methotrexate sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 201749-001 | May 21, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Pharmachemie Bv | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040843-004 | Jan 11, 2010 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sandoz Inc | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 090029-001 | Mar 31, 2009 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Zydus Pharms | METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 207812-001 | Jan 13, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hospira | METHOTREXATE PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 011719-014 | Apr 13, 2005 | 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 |
International Patents for methotrexate sodium
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2614814 | Start Trial |
| United Kingdom | 201200192 | Start Trial |
| Spain | 2726524 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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 verification 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.
ISSN: 2162-2639
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