FDA Orange Book

Generic for Neoprofen

Neoprofen contains ibuprofen. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Neoprofen is ibuprofen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Neoprofen products in the Orange Book

Neoprofen products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, intravenous	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	Marketed (Rx)	AP	1	AP

NDA 021903, held by RECORDATI RARE DISEASES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic ibuprofen

Approved generic versions of Neoprofen
Company	ANDA	TE code	Approved	Strengths
XGEN PHARMACEUTICALS DJB INC	202402	AP (A-rated, therapeutically equivalent)	March 30, 2016	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

Neoprofen patents

Patents listed for Neoprofen
Patent	Expires	Covers	Use code	NDA
8415337	March 2, 2032	Drug substance, Drug product	None	021903

Neoprofen NDC codes

Questions

Is there a generic for Neoprofen?

Yes. The generic name for Neoprofen is ibuprofen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for Neoprofen?

The active ingredient in Neoprofen is ibuprofen, per the FDA Orange Book.

When does the Neoprofen patent expire?

The last patent listed for Neoprofen in the Orange Book expires March 2, 2032. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.