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Serving leading biopharmaceutical companies globally:

Moodys
US Department of Justice
Fuji
Baxter
McKinsey
Citi
Fish and Richardson
Argus Health
Colorcon
Accenture

Generated: October 22, 2017

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Methotrexate sodium - Generic Drug Details

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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, Orion Corp Orion, 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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Methotrexate sodium has two patent family members in two countries.

There are twenty drug master file entries for methotrexate sodium. Twenty-six suppliers are listed for this compound.

Summary for Generic Name: methotrexate sodium

US Patents:1
Tradenames:12
Applicants:22
NDAs:45
Drug Master File Entries: see list20
Suppliers / Packagers: see list26
Bulk Api Vendors: see list105
Clinical Trials: see list3,924
Patent Applications: see list9,701
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:methotrexate sodium at DailyMed

Pharmacology for Ingredient: methotrexate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc
METHOTREXATE SODIUM PRESERVATIVE FREE
methotrexate sodium
INJECTABLE;INJECTION090039-001Mar 31, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
METHOTREXATE SODIUM
methotrexate sodium
TABLET;ORAL081235-001May 15, 1992ABRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
METHOTREXATE SODIUM
methotrexate sodium
INJECTABLE;INJECTION011719-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Abic
ABITREXATE
methotrexate sodium
INJECTABLE;INJECTION089356-001Jul 17, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Pharmacia And Upjohn
FOLEX
methotrexate sodium
INJECTABLE;INJECTION087695-002Apr 8, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe
Barr
TREXALL
methotrexate sodium
TABLET;ORAL040385-002Mar 21, 2001RXNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms Int
METHOTREXATE SODIUM
methotrexate sodium
INJECTABLE;INJECTION089342-001Sep 16, 1986RXNoYes► Subscribe► Subscribe► Subscribe
Norbrook
METHOTREXATE SODIUM
methotrexate sodium
INJECTABLE;INJECTION088648-001May 9, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Accord Hlthcare
METHOTREXATE SODIUM PRESERVATIVE FREE
methotrexate sodium
INJECTABLE;INJECTION040716-001Apr 30, 2007APRXNoYes► Subscribe► Subscribe► Subscribe
Abic
ABITREXATE
methotrexate sodium
INJECTABLE;INJECTION089355-001Jul 17, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
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International Patent Family for Ingredient: methotrexate sodium

Country Document Number Estimated Expiration
United Kingdom201200192► Subscribe
European Patent Office2614814► 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 leading biopharmaceutical companies globally:

Fish and Richardson
Novartis
Chubb
Colorcon
Julphar
Fuji
US Army
QuintilesIMS
Merck
Citi

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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