Is there a generic for Thalidomide?

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

What is the reference-listed drug for Thalidomide?

THALOMID (NDA 020785, BRISTOL-MYERS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Thalidomide are approved?

Thalidomide is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Thalidomide

Thalidomide is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:THALOMID · NDA 020785

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
THALOMIDRLD×4	BRISTOL-MYERS	NDA 020785	AB	Jul 16, 1998

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
THALIDOMIDE×4	NATCO	ANDA 213267	AB	Apr 24, 2026

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Thalidomide — frequently asked questions

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

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