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Last Updated: December 3, 2022

Ibuprofen lysine - Generic Drug Details


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What are the generic drug sources for ibuprofen lysine and what is the scope of freedom to operate?

Ibuprofen lysine is the generic ingredient in two branded drugs marketed by Xgen Pharms and Recordati Rare, and is included in two 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 is one drug master file entry for ibuprofen lysine. Three suppliers are listed for this compound.

Recent Clinical Trials for ibuprofen lysine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Oxford Pharmascience LtdPhase 1
Simbec ResearchPhase 1
Reckitt Benckiser Healthcare (UK) LimitedPhase 1

See all ibuprofen lysine clinical trials

Pharmacology for ibuprofen lysine
Paragraph IV (Patent) Challenges for IBUPROFEN LYSINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NEOPROFEN Injection ibuprofen lysine 10 mg/mL, 2 mL vials 021903 1 2010-10-01

US Patents and Regulatory Information for ibuprofen lysine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Xgen Pharms IBUPROFEN LYSINE ibuprofen lysine INJECTABLE;INTRAVENOUS 202402-001 Mar 30, 2016 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Recordati Rare NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903-001 Apr 13, 2006 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ibuprofen lysine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Recordati Rare NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
Recordati Rare NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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