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Serving 500+ biopharmaceutical companies globally:

Accenture
Harvard Business School
McKesson
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Moodys
Johnson and Johnson
Boehringer Ingelheim
Cantor Fitzgerald
Julphar
Deloitte

Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,318,802

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Which drugs does patent 8,318,802 protect, and when does it expire?


Patent 8,318,802 protects VELETRI and is included in one NDA.

This patent has fourteen patent family members in thirteen countries.

Summary for Patent: 8,318,802

Title:Epoprostenol formulation and method of making thereof
Abstract: This invention relates to a stable epoprostenol composition that can be combined with commercially available IV fluids and can be administered in its reconstituted and/or diluted form under ambient conditions of about 15-30.degree. C. for greater than 24 hours. The composition preferably contains (a) epoprostenol or a salt thereof; (b) a alkalinization agent; and (c) a base, such that when reconstituted or in solution, the solution has a pH>11. Methods for making the lyophilized composition are also disclosed.
Inventor(s): Palepu; Naglesh R. (Southampton, PA)
Assignee: Actelion Pharmaceuticals Ltd. (Altschwil, CH)
Application Number:12/278,061
Patent Claim Types:
see list of patent claims
Composition; Formulation;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Actelion Pharms Ltd
VELETRI
epoprostenol sodium
INJECTABLE;INJECTION022260-002Jun 28, 2012RXYesNo8,318,802► SubscribeY
Actelion Pharms Ltd
VELETRI
epoprostenol sodium
INJECTABLE;INJECTION022260-001Jun 27, 2008RXYesYes8,318,802► SubscribeY
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Foreign Priority and PCT Information for Patent: 8,318,802

PCT Information
PCT FiledFebruary 02, 2007PCT Application Number:PCT/US2007/002948
PCT Publication Date:August 16, 2007PCT Publication Number: WO2007/092343

Non-Orange Book Patents for Patent: 8,318,802

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
8,598,227Epoprostenol formulation and method of making thereof► 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: 8,318,802

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada2868998► Subscribe
China101410119► Subscribe
Cyprus1117128► Subscribe
Denmark1993557► Subscribe
European Patent Office1993557► 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 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Novartis
McKesson
Chubb
Daiichi Sankyo
Citi
Johnson and Johnson
Federal Trade Commission
Dow
Harvard Business School

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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