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Serving leading biopharmaceutical companies globally:

Healthtrust
Novartis
Farmers Insurance
Julphar
Cerilliant
Chinese Patent Office
Argus Health
Cipla
Teva
Colorcon

Generated: December 16, 2017

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Methotrexate - Generic Drug Details

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What are the generic drug sources for methotrexate and what is the scope of methotrexate freedom to operate?

Methotrexate
is the generic ingredient in fifteen branded drugs marketed by Antares Pharma Inc, Medac Pharma Inc, Abic, Pharmacia And Upjohn, Hospira, Fresenius Kabi Usa, Abraxis Pharm, Norbrook, Pharmachemie Usa, West-ward Pharms Int, Accord Hlthcare, Mylan Labs Ltd, Pharmachemie Bv, Sandoz Inc, Bristol, Bristol Myers, Bristol Myers Squibb, Silvergate Pharms, Barr, Dava Pharms Inc, Duramed Pharms Barr, Mylan, Sun Pharma Global, and Zydus Pharms Usa Inc, and is included in forty-seven NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Methotrexate has sixty-one patent family members in twenty-one countries.

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

Pharmacology for methotrexate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abraxis PharmMETHOTREXATE SODIUMmethotrexate sodiumINJECTABLE;INJECTION089323-001Jun 13, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz IncMETHOTREXATE SODIUM PRESERVATIVE FREEmethotrexate sodiumINJECTABLE;INJECTION090039-002Mar 31, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Antares Pharma IncOTREXUPmethotrexateSOLUTION;SUBCUTANEOUS204824-005Nov 7, 2014DISCNNoNo► Subscribe► SubscribeY► Subscribe
Antares Pharma IncOTREXUP PFSmethotrexateSOLUTION;SUBCUTANEOUS204824-014May 31, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Antares Pharma IncOTREXUPmethotrexateSOLUTION;SUBCUTANEOUS204824-005Nov 7, 2014DISCNNoNo► Subscribe► SubscribeY► Subscribe
Antares Pharma IncOTREXUPmethotrexateSOLUTION;SUBCUTANEOUS204824-005Nov 7, 2014DISCNNoNo► Subscribe► SubscribeY► Subscribe
Antares Pharma IncOTREXUPmethotrexateSOLUTION;SUBCUTANEOUS204824-007Mar 24, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
Antares Pharma IncOTREXUPmethotrexateSOLUTION;SUBCUTANEOUS204824-005Nov 7, 2014DISCNNoNo► Subscribe► SubscribeY► Subscribe
Antares Pharma IncOTREXUPmethotrexateSOLUTION;SUBCUTANEOUS204824-002Oct 11, 2013RXYesNo► Subscribe► SubscribeY► Subscribe
Antares Pharma IncOTREXUPmethotrexateSOLUTION;SUBCUTANEOUS204824-005Nov 7, 2014DISCNNoNo► Subscribe► SubscribeY► 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
9,180,259Prefilled syringe jet injector► Subscribe
9,750,881Hazardous agent injection system► Subscribe
6,565,553 Needle assisted 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
South Korea20090079876► Subscribe
European Patent Office1104317► Subscribe
Germany69921704► Subscribe
Canada2595730► Subscribe
Germany69908140► Subscribe
China1323230► Subscribe
Australia2010226442► Subscribe
Israel184765► Subscribe
Germany202007019703► Subscribe
Japan2009544636► 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:

Julphar
Harvard Business School
UBS
Daiichi Sankyo
Mallinckrodt
AstraZeneca
Merck
Chubb
Baxter
US Department of Justice

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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