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Last Updated: April 12, 2024

IBUPROFEN Drug Patent Profile

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Drug patent expirations by year for IBUPROFEN
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Drug Sales Revenue Trends for IBUPROFEN

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Paragraph IV (Patent) Challenges for IBUPROFEN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PEDIATRIC ADVIL Oral Suspension ibuprofen 50 mg/1.25 mL 020812 1 2007-06-29

US Patents and Regulatory Information for IBUPROFEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Granules IBUPROFEN ibuprofen TABLET;ORAL 202312-001 Oct 7, 2016 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Marksans Pharma IBUPROFEN ibuprofen TABLET;ORAL 090796-003 Dec 21, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Ny IBUPROFEN ibuprofen TABLET;ORAL 071334-001 Nov 25, 1986 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo IBUPROFEN ibuprofen TABLET, CHEWABLE;ORAL 076359-002 Jan 16, 2004 OTC No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for IBUPROFEN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Recordati Rare Diseases Pedea ibuprofen EMEA/H/C/000549
Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Authorised no no no 2004-07-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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