Is there a generic for Betaine?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Betaine, referencing the brand CYSTADANE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Betaine?

CYSTADANE (NDA 020576, RECORDATI RARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Betaine are approved?

Betaine is approved in the following dosage form: for solution.

FDA Orange Book · active-ingredient family

Betaine

Betaine is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CYSTADANE · NDA 020576

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for solution

Product	Applicant	Application	TE	Approved
CYSTADANERLD	RECORDATI RARE	NDA 020576	AB	Oct 25, 1996

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
BETAINE	ETON	ANDA 210508	AB	Jan 28, 2022
BETAINE	NOVITIUM PHARMA	ANDA 214864	AB	Nov 23, 2021

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.

Betaine — frequently asked questions

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

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