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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Express Scripts
Deloitte
Chinese Patent Office
UBS
US Army
Citi
QuintilesIMS
Teva
Queensland Health

Generated: October 21, 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, 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-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.

Summary for Generic Name: methotrexate

US Patents:15
Tradenames:15
Applicants:24
NDAs:47
Drug Master File Entries: see list20
Suppliers / Packagers: see list2
Bulk Api Vendors: see list74
Clinical Trials: see list1,633
Patent Applications: see list9,864
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:methotrexate at DailyMed

Pharmacology for Ingredient: methotrexate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd
METHOTREXATE SODIUM PRESERVATIVE FREE
methotrexate sodium
INJECTABLE;INJECTION201530-001Mar 29, 2012APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
METHOTREXATE SODIUM PRESERVATIVE FREE
methotrexate sodium
INJECTABLE;INJECTION011719-012Apr 13, 2005APRXYesYes► Subscribe► Subscribe► Subscribe
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-008Mar 24, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-004Oct 11, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Hospira
METHOTREXATE SODIUM
methotrexate sodium
INJECTABLE;INJECTION011719-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-004Oct 11, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-004Oct 11, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-005Nov 7, 2014DISCNNoNo► Subscribe► SubscribeY ► Subscribe
West-ward Pharms Int
METHOTREXATE SODIUM
methotrexate sodium
INJECTABLE;INJECTION089341-001Sep 16, 1986APRXNoYes► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
METHOTREXATE SODIUM PRESERVATIVE FREE
methotrexate sodium
INJECTABLE;INJECTION201529-003Mar 29, 2012APRXNoNo► Subscribe► 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
6,428,528 Needle assisted jet injector► Subscribe
9,750,881Hazardous agent injection system► Subscribe
9,180,259Prefilled syringe jet injector► Subscribe
6,565,553 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
World Intellectual Property Organization (WIPO)2008009476► Subscribe
South Korea20090079876► Subscribe
CroatiaP20110148► Subscribe
Australia5470499► Subscribe
Russian Federation2403044► Subscribe
Japan2009544636► Subscribe
BrazilPI0715433► Subscribe
Austria281195► Subscribe
Japan2015042270► Subscribe
Japan2008528126► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chubb
QuintilesIMS
Teva
Daiichi Sankyo
Queensland Health
Novartis
Fish and Richardson
Dow
AstraZeneca
Cantor Fitzgerald

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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