Is there a generic for Ibuprofen lysine?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Ibuprofen lysine, referencing the brand NEOPROFEN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ibuprofen lysine?

NEOPROFEN (NDA 021903, RECORDATI RARE) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Ibuprofen lysine?

The Orange Book lists 1 patent against Ibuprofen lysine products, with the earliest listed expiry in 2032. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Ibuprofen lysine are approved?

Ibuprofen lysine is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Ibuprofen lysine

Ibuprofen lysine: 1 brand, 1 generic; first approved Apr 13, 2006; generic available.

Generic available

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Mar 02, 2032

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 02, 2032

in 5 yr 5 mo

Brand (NDA) products

Originator applications

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NEOPROFENRLDRS
RECORDATI RARENDA 0219032006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE INTRAVENOUS Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Generic (ANDA) products (1)

Abbreviated applications

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IBUPROFEN LYSINE
XGEN PHARMSANDA 2024022016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE INTRAVENOUS Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8415337	Mar 02, 2032	in 5 yr 5 mo	SubstanceProduct

Approval history

FDA approval span

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First approval

Apr 13, 2006

20 yr 10 mo ago

Most recent approval

Mar 30, 2016

10 yr 9 mo ago

Approvals span 2006–2016 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Ibuprofen lysine: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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