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Serving 500+ biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Chubb
US Department of Justice
Harvard Business School
Dow
Covington
Accenture
Johnson and Johnson
Express Scripts

Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for Patent: ► Subscribe

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Which drugs does patent 8,895,058 protect, and when does it expire?


Patent ► Subscribe protects QSYMIA and is included in one NDA. There has been one Paragraph IV challenge on Qsymia.

This patent has thirty-three patent family members in fifteen countries.

Summary for Patent: ► Subscribe

Title:Low dose topiramate/phentermine composition and methods of use thereof
Abstract: A method for effecting weight loss by administering a combination of topiramate and phentermine is provided. The phentermine is generally administered in immediate release form, in a daily dose in the range of 2 mg to 8 mg, in combination with a daily dose of topiramate selected to prevent the loss of effectiveness of phentermine alone. Methods for treating obesity, conditions associated with obesity, and other indications are also provided, as are compositions and dosage forms containing low doses of phentermine and topiramate, e.g., 3.75 mg phentermine and 23 mg topiramate.
Inventor(s): Najarian; Thomas (Los Osos, CA), Tam; Peter Y. (Redwood City, CA), Wilson; Leland F. (Menlo Park, CA)
Assignee: Vivus, Inc. (Mountain View, CA)
Application Number:14/048,576
Patent Claim Types:
see list of patent claims
Formulation; Dosage form; Composition;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-001Jul 17, 2012RXYesNo► Subscribe► SubscribeY
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-002Jul 17, 2012RXYesNo► Subscribe► SubscribeY
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-003Jul 17, 2012RXYesNo► Subscribe► SubscribeY
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-004Jul 17, 2012RXYesYes► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: ► Subscribe

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
8,580,298Low dose topiramate/phentermine composition and methods of use thereof► Subscribe
9,011,905Low dose topiramate/phentermine composition and methods of use thereof► Subscribe
8,895,057Escalating dosing regimen for effecting weight loss and treating obesity► Subscribe
9,011,906Escalating dosing regimen for effecting weight loss and treating obesity► Subscribe
8,580,299Escalating dosing regimen for effecting weight loss and treating obesity► 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: ► Subscribe

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2009257573► Subscribe
Canada2727313► Subscribe
Canada2727319► Subscribe
European Patent Office2317997► Subscribe
China102112126► Subscribe
China102112127► Subscribe
Spain2606041► Subscribe
Hong Kong1213489► Subscribe
Israel209874► Subscribe
Israel209875► 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:

Cerilliant
Express Scripts
Merck
Daiichi Sankyo
Federal Trade Commission
Johnson and Johnson
US Department of Justice
UBS
QuintilesIMS
Mallinckrodt

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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