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Ibuprofen lysine - Generic Drug Details

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Ibuprofen lysine is the generic ingredient in two branded drugs marketed by Exela Pharma Science and Recordati Rare, and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has twelve patent family members in six countries.

There are sixty-three drug master file entries for ibuprofen lysine. Three suppliers are listed for this compound.

Summary for Generic Name: ibuprofen lysine

Drug Master File Entries: see list63
Suppliers / Packagers: see list3
Clinical Trials: see list223
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ibuprofen lysine at DailyMed

Pharmacology for Ingredient: ibuprofen lysine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Recordati Rare
ibuprofen lysine
INJECTABLE;INTRAVENOUS021903-001Apr 13, 2006RXYesYes8,415,337► subscribeYY ► subscribe
Exela Pharma Science
ibuprofen lysine
INJECTABLE;INTRAVENOUS202402-001Mar 30, 2016RXNoNo► subscribe► subscribe
Recordati Rare
ibuprofen lysine
INJECTABLE;INTRAVENOUS021903-001Apr 13, 2006RXYesYes6,344,479► subscribeYYY ► subscribe
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International Patent Family for Ingredient: ibuprofen lysine

Country Document Number Estimated Expiration
Germany60209269► subscribe
Austria318136► subscribe
European Patent Office1249234► 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.