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Serving leading biopharmaceutical companies globally:

Baxter
UBS
Covington
Cipla
Accenture
Healthtrust
Fish and Richardson
Johnson and Johnson
Moodys
US Army

Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,480,631

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Which drugs does patent 8,480,631 protect, and when does it expire?


Patent 8,480,631 protects OTREXUP and is included in one NDA.

This patent has twelve patent family members in seven countries.

Summary for Patent: 8,480,631

Title:Hazardous agent injection system
Abstract: A hazardous agent injection system including from about 0.02 ml to about 4.0 ml of methotrexate at a concentration of from about 7.5 mg/ml to about 150 mg/ml; a needle-assisted jet injector including a container configured to contain the methotrexate; a injection outlet member associated with the container; an injection-assisting needle coupled to the injection outlet member; a firing mechanism associated with the container; an energy source associated with the firing mechanism; and a trigger mechanism associated with the firing mechanism, wherein the needle-assisted jet injector is configured to eject the methotrexate from the injection outlet member such that the C.sub.max, T.sub.max and bioavailability of the needle-assisted jet injected methotrexate falls between about 80% and about 125% of the C.sub.max, T.sub.max and bioavailability of methotrexate delivered by a hand-powered syringe.
Inventor(s): Wotton; Paul (Stamford, CT), Sadowsky; Peter L. (Woodbury, MN), Hayes; John William (Chaska, MN)
Assignee: Antares Pharma, Inc. (Ewing, NJ)
Application Number:13/607,659
Patent Claim Types:
see list of patent claims
Dosage form; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-005Nov 7, 2014DISCNNoNo► Subscribe► SubscribeY SUBCUTANEOUS INJECTION OF METHOTREXATE
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-001Oct 11, 2013RXYesNo► Subscribe► SubscribeY SUBCUTANEOUS INJECTION OF METHOTREXATE
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-006Mar 24, 2016RXYesNo► Subscribe► SubscribeY SUBCUTANEOUS INJECTION OF METHOTREXATE
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-002Oct 11, 2013RXYesNo► Subscribe► SubscribeY SUBCUTANEOUS INJECTION OF METHOTREXATE
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-007Mar 24, 2016RXYesNo► Subscribe► SubscribeY SUBCUTANEOUS INJECTION OF METHOTREXATE
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-003Oct 11, 2013RXYesNo► Subscribe► SubscribeY SUBCUTANEOUS INJECTION OF METHOTREXATE
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-008Mar 24, 2016RXYesNo► Subscribe► SubscribeY SUBCUTANEOUS INJECTION OF METHOTREXATE
Antares Pharma Inc
OTREXUP
methotrexate
SOLUTION;SUBCUTANEOUS204824-004Oct 11, 2013RXYesYes► Subscribe► SubscribeY SUBCUTANEOUS INJECTION OF METHOTREXATE
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Non-Orange Book Patents for Patent: 8,480,631

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
8,579,865Hazardous agent injection system► Subscribe
9,750,881Hazardous agent injection system► Subscribe
9,421,333Hazardous agent injection system► Subscribe
8,945,063Hazardous agent injection system► 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 Patent: 8,480,631

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada2755779► Subscribe
Japan5968976► Subscribe
European Patent Office2408493► Subscribe
Japan2012521224► Subscribe
Japan5732039► Subscribe
Japan2015042270► Subscribe
Japan2016104214► Subscribe
South Korea20120028294► Subscribe
South Korea101597672► Subscribe
China102612381► 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:

Accenture
Harvard Business School
Baxter
US Army
Cipla
Boehringer Ingelheim
McKesson
Julphar
Queensland Health
QuintilesIMS

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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