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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Citi
McKinsey
QuintilesIMS
Accenture
Mallinckrodt
Dow
Daiichi Sankyo
Healthtrust
Argus Health

Generated: August 19, 2017

DrugPatentWatch Database Preview

SUPRAX Drug Profile

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What is the patent landscape for Suprax, and when can generic versions of Suprax launch?

Suprax is a drug marketed by Lederle, Lupin Pharms, and Lupin Ltd. and is included in eight NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in SUPRAX is cefixime. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cefixime profile page.

Summary for Tradename: SUPRAX

Patents:1
Applicants:3
NDAs:8
Suppliers / Packagers: see list5
Bulk Api Vendors: see list57
Clinical Trials: see list2
Patent Applications: see list4,376
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SUPRAX at DailyMed

Pharmacology for Tradename: SUPRAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lederle
SUPRAX
cefixime
TABLET;ORAL050621-001Apr 28, 1989DISCNYesNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
SUPRAX
cefixime
TABLET, CHEWABLE;ORAL065380-001Oct 25, 2010RXNoNo► Subscribe► Subscribe► Subscribe
Lupin Pharms
SUPRAX
cefixime
FOR SUSPENSION;ORAL065129-001Feb 23, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
SUPRAX
cefixime
TABLET, CHEWABLE;ORAL065380-002Oct 25, 2010RXNoNo► Subscribe► Subscribe► Subscribe
Lederle
SUPRAX
cefixime
TABLET;ORAL050621-002Apr 28, 1989DISCNYesNo► Subscribe► Subscribe► Subscribe
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Paragraph IV activity for: SUPRAX

Drugname Dosage Strength RLD Submissiondate
cefiximefor Oral Suspension500 mg/5 mLSuprax7/22/2014

Non-Orange Book Patents for Tradename: SUPRAX

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
9,241,905Pharmaceutical compositions of Cefixime► 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 Tradename: SUPRAX

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2007119249► Subscribe
Germany112007000920► 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:

Federal Trade Commission
Fish and Richardson
Colorcon
McKesson
Citi
US Army
Farmers Insurance
Deloitte
Harvard Business School
Fuji

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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