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OTREXUP Drug Profile

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Which patents cover Otrexup, and what substitute generic drugs are available?

Otrexup is a drug marketed by Antares Pharma Inc and is included in one NDA. There are twelve patents protecting this drug.

This drug has thirty-four patent family members in twelve countries.

The generic ingredient in OTREXUP is methotrexate. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methotrexate profile page.

Summary for Tradename: OTREXUP

Patents:12
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list73
Clinical Trials: see list1
Patent Applications: see list9,556
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:OTREXUP at DailyMed

Pharmacology for Tradename: OTREXUP

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-008Mar 24, 2016RXYesNo8,562,564► SubscribeY ► Subscribe
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-002Oct 11, 2013RXYesNo7,776,015► SubscribeY ► Subscribe
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-006Mar 24, 2016RXYesNo9,533,102► SubscribeY ► Subscribe
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-004Oct 11, 2013RXYesYes7,776,015► SubscribeY ► Subscribe
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-007Mar 24, 2016RXYesNoRE44847► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: OTREXUP

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
6,565,553 Needle assisted jet injector► Subscribe
9,180,259Prefilled syringe 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 Tradename: OTREXUP

Country Document Number Estimated Expiration
Spain2229183► Subscribe
Canada2755779► Subscribe
European Patent Office1104317► Subscribe
South Korea101597672► 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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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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