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Last Updated: January 21, 2021

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OTREXUP Drug Profile

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Which patents cover Otrexup, and when can generic versions of Otrexup launch?

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 forty-eight patent family members in fifteen countries.

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

US ANDA Litigation and Generic Entry Outlook for Otrexup

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for OTREXUP
Drug Prices for OTREXUP

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Drug Sales Revenue Trends for OTREXUP

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Recent Clinical Trials for OTREXUP

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SponsorPhase
University of Wisconsin, MadisonPhase 1
University of VirginiaPhase 1
Vanderbilt UniversityPhase 1

See all OTREXUP clinical trials

US Patents and Regulatory Information for OTREXUP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-003 Oct 11, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Antares Pharma Inc OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824-013 May 31, 2017 DISCN Yes No   Start Trial   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for OTREXUP

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
AstraZeneca
Merck
Boehringer Ingelheim
McKinsey

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 verification 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.