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Serving leading biopharmaceutical companies globally:

Teva
Federal Trade Commission
US Army
Moodys
Deloitte
Baxter
Fuji
Julphar
Farmers Insurance
Accenture

Generated: January 23, 2018

DrugPatentWatch Database Preview

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 thirteen 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.

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 No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Antares Pharma Inc OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824-013 May 31, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-007 Mar 24, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-003 Oct 11, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Antares Pharma Inc OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824-014 May 31, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-007 Mar 24, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
9,180,259 Prefilled syringe jet injector ➤ Subscribe
6,565,553 Needle assisted jet injector ➤ Subscribe
9,750,881 Hazardous agent injection system ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for OTREXUP

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Dow
Covington
Novartis
Merck
Teva
Healthtrust
Colorcon

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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