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Generated: October 23, 2018

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Ibuprofen; pseudoephedrine hydrochloride - Generic Drug Details

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What are the generic drug sources for ibuprofen; pseudoephedrine hydrochloride and what is the scope of ibuprofen; pseudoephedrine hydrochloride patent protection?

Ibuprofen; pseudoephedrine hydrochloride is the generic ingredient in six branded drugs marketed by Pfizer, Aurobindo Pharma Ltd, J And J Consumer Inc, Perrigo, Contract Pharmacal, Dr Reddys Labs Ltd, and Ohm Labs, and is included in ten NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are sixty-four drug master file entries for ibuprofen; pseudoephedrine hydrochloride. Twenty-two suppliers are listed for this compound.

Pharmacology for ibuprofen; pseudoephedrine hydrochloride

US Patents and Regulatory Information for ibuprofen; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Contract Pharmacal IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 075588-001 Apr 8, 2002 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer CHILDREN'S ADVIL COLD ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021373-001 Apr 18, 2002 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 077628-001 Aug 14, 2006 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Perrigo IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 076478-001 Nov 5, 2003 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
J And J Consumer Inc CHILDREN'S MOTRIN COLD ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021128-001 Aug 1, 2000 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 209235-001 Dec 1, 2017 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 019771-001 Sep 19, 1989 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ibuprofen; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 021374-001 May 30, 2002 ➤ Sign Up ➤ Sign Up
Pfizer ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 019771-001 Sep 19, 1989 ➤ Sign Up ➤ Sign Up
Pfizer ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 021374-001 May 30, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
McKinsey
Fuji
Julphar
UBS
Johnson and Johnson
Harvard Business School
AstraZeneca
Cipla

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