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Methotrexate - Generic Drug Details

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Methotrexate is the generic ingredient in thirteen branded drugs marketed by Antares Pharma Inc, Medac Pharma 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, Roxane, Pharmachemie Usa, Bristol, Bristol Myers, Fresenius Kabi Usa, Dava Pharms Inc, Barr, and Bristol Myers Squibb, and is included in forty-eight NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-seven patent family members in twenty-one countries.

There are twenty drug master file entries for methotrexate. Two suppliers are listed for this compound.

Summary for Generic Name: methotrexate

Tradenames:13
Patents:12
Applicants:23
NDAs:48
Drug Master File Entries: see list20
Suppliers / Packaging: see list2
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: methotrexate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-001Oct 11, 2013RXNo7,776,015► subscribeY ► subscribe
Mylan Labs Ltd
METHOTREXATE SODIUM PRESERVATIVE FREE
methotrexate sodium
INJECTABLE;INJECTION201529-004Mar 29, 2012RXNo► subscribe► subscribe
Bristol
MEXATE
methotrexate sodium
INJECTABLE;INJECTION086358-004Approved Prior to Jan 1, 1982DISCNNo► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: methotrexate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,565,553 Needle assisted jet injector► subscribe
9,180,259Prefilled syringe jet injector► subscribe
6,428,528 Needle assisted jet injector► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: methotrexate

Country Document Number Estimated Expiration
Canada2659662► subscribe
Spain2355399► subscribe
Cyprus1111159► 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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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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