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 6 mo

Brand (NDA) products

Originator applications

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

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

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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 6 mo	SubstanceProduct

Approval history

FDA approval span

First approval

Apr 13, 2006

20 yr 10 mo ago

Most recent approval

Mar 30, 2016

10 yr 8 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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