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Last Updated: April 6, 2020

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NEOPROFEN Drug Profile


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When do Neoprofen patents expire, and when can generic versions of Neoprofen launch?

Neoprofen is a drug marketed by Recordati Rare and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twelve patent family members in six countries.

The generic ingredient in NEOPROFEN is ibuprofen lysine. There are sixty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibuprofen lysine profile page.

US ANDA Litigation and Generic Entry Outlook for Neoprofen

A generic version of NEOPROFEN was approved as ibuprofen lysine by X-GEN PHARMS INC on March 30th, 2016.

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Drug patent expirations by year for NEOPROFEN
Drug Prices for NEOPROFEN

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Recent Clinical Trials for NEOPROFEN

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SponsorPhase
OSF Healthcare SystemPhase 4

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Pharmacology for NEOPROFEN
Synonyms for NEOPROFEN
(2S)-2,6-bis(azanyl)hexanoic acid; 2-[4-(2-methylpropyl)phenyl]propanoic acid
(2S)-2,6-diaminohexanoic acid,2-[4-(2-methylpropyl)phenyl]propanoic acid
(2S)-2,6-diaminohexanoic acid; 2-[4-(2-methylpropyl)phenyl]propanoic acid
(S)-2,6-Diaminohexanoic acid compound with 2-(4-isobutylphenyl)propanoic acid (1:1)
2,6-diaminohexanoic acid,2-[4-(2-methylpropyl)phenyl]propanoic acid
469I779
57469-76-8
57469-77-9
A831448
AB01274868_02
AB01274868-01
AB2000139
ABP000512
AKOS015994629
Arflamin
BCP9000769
CHEMBL1201141
D06606
HS-0089
Ibuprofen L-lysine (JAN)
Ibuprofen lysinate
IBUPROFEN LYSINE
Ibuprofen Lysine (NeoProfen)
Ibuprofen lysine (USAN)
Ibuprofen lysine [USAN]
Ibuprofen lysine/
Ibuprofen-Lysine(Motrin)
KS-00002WUK
L-lysine compound with 2-(4-isobutylphenyl)propanoic acid (1:1)
Neoprofen (TN)
Q27284326
s1518
SC-16390
SCHEMBL44617
Solufenum
Paragraph IV (Patent) Challenges for NEOPROFEN
Tradename Dosage Ingredient NDA Submissiondate
NEOPROFEN INJECTABLE;INTRAVENOUS ibuprofen lysine 021903 2010-10-01

US Patents and Regulatory Information for NEOPROFEN

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   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
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
>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:

Medtronic
Express Scripts
Colorcon
Mallinckrodt
Merck
McKesson

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