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Cefixime - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for cefixime?

Cefixime is the generic ingredient in two branded drugs marketed by Lederle, Lupin Pharms, Aurobindo Pharma Ltd, Belcher Pharms Llc, and Lupin Ltd, and is included in eleven NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cefixime has two patent family members in two countries.

There are fourteen drug master file entries for cefixime. Eight suppliers are listed for this compound.

Summary for Generic Name: cefixime

Tradenames:2
Patents:2
Applicants:5
NDAs:11
Drug Master File Entries: see list14
Suppliers / Packagers: see list8
Bulk Api Vendors: see list43
Clinical Trials: see list5
Patent Applications: see list6,887
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:cefixime at DailyMed

Pharmacology for Ingredient: cefixime

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd
CEFIXIME
cefixime
FOR SUSPENSION;ORAL204835-001Apr 14, 2015RXNoNo► Subscribe► Subscribe
Lederle
SUPRAX
cefixime
FOR SUSPENSION;ORAL050622-001Apr 28, 1989DISCNYesNo► Subscribe► Subscribe
Lederle
SUPRAX
cefixime
TABLET;ORAL050621-002Apr 28, 1989DISCNYesNo► Subscribe► Subscribe
Lupin Pharms
SUPRAX
cefixime
TABLET;ORAL065130-001Feb 12, 2004RXNoYes► Subscribe► Subscribe
Belcher Pharms Llc
CEFIXIME
cefixime
FOR SUSPENSION;ORAL206938-001Feb 6, 2017RXNoNo► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: cefixime

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 Ingredient: cefixime

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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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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