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Last Updated: March 1, 2021

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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 are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ibuprofen lysine has twelve patent family members in six countries.

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

Summary for ibuprofen lysine
International Patents:12
US Patents:3
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 64
Suppliers / Packagers: 3
Bulk Api Vendors: 68
Clinical Trials: 3
Patent Applications: 303
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in ibuprofen lysine?ibuprofen lysine excipients list
DailyMed Link:ibuprofen lysine at DailyMed
Recent Clinical Trials for ibuprofen lysine

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

SponsorPhase
Simbec ResearchPhase 1
Reckitt Benckiser Healthcare (UK) LimitedPhase 1
FarmaconPhase 3

See all ibuprofen lysine clinical trials

Pharmacology for ibuprofen lysine
Paragraph IV (Patent) Challenges for IBUPROFEN LYSINE
Tradename Dosage Ingredient NDA Submissiondate
NEOPROFEN INJECTABLE;INTRAVENOUS ibuprofen lysine 021903 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
Recordati Rare NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903-001 Apr 13, 2006 AP RX Yes Yes   Start Trial   Start Trial Y Y Y   Start Trial
Recordati Rare NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903-001 Apr 13, 2006 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Recordati Rare NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903-001 Apr 13, 2006 AP RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Xgen Pharms IBUPROFEN LYSINE ibuprofen lysine INJECTABLE;INTRAVENOUS 202402-001 Mar 30, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Colorcon

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