Is there a generic for Miglitol?

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

What is the reference-listed drug for Miglitol?

GLYSET (NDA 020682, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Miglitol are approved?

Miglitol is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Miglitol

Miglitol 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:GLYSET · NDA 020682

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
GLYSETRLD×3	PFIZER	NDA 020682	—	Dec 18, 1996

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
MIGLITOL×3	ORIENT PHARMA	ANDA 203965	—	Feb 24, 2015

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.

Miglitol — frequently asked questions

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

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