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: 1 brand, 1 generic; first approved Dec 18, 1996; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 1 ANDA application approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

GLYSETRLD

PFIZERNDA 02068219963 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (1)

MIGLITOLRS

ORIENT PHARMAANDA 20396520153 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	—
50MG	TABLET	ORAL	Rx	—
100MG	TABLET	ORAL	Rx	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Dec 18, 1996

30 yr ago

Most recent approval

Feb 24, 2015

11 yr 7 mo ago

Approvals span 1996–2015 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Miglitol — 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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