Is there a generic for Miglustat?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Miglustat, referencing the brand OPFOLDA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Miglustat?

OPFOLDA (NDA 215211, AMICUS THERAP US) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Miglustat?

The Orange Book lists 10 patents against Miglustat products, with the earliest listed expiry in 2033. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Miglustat have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Miglustat. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Miglustat are approved?

Miglustat is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Miglustat

Miglustat: 2 brands, 4 generics; first approved Jul 31, 2003; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available: 4 ANDA applications approved.

Earliest patent expiry Mar 07, 2033Latest exclusivity ends Sep 28, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 07, 2033

in 6 yr 6 mo

Brand (NDA) products

Originator applications

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OPFOLDARLDRS
AMICUS THERAP USNDA 2152112023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
65MG CAPSULE ORAL Rx -
ZAVESCARLDRS
ACTELIONNDA 0213482003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
65MG	CAPSULE	ORAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	AB

Generic (ANDA) products (4)

Abbreviated applications

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MIGLUSTAT
NAVINTA LLCANDA 2191112025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB
MIGLUSTAT
CHARTWELL RXANDA 2093252022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Discontinued -
YARGESA
EDENBRIDGE PHARMSANDA 2098212020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB
MIGLUSTAT
ANI PHARMSANDA 2083422018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

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NPNew product exclusivity (3 years)
Sep 28, 2026
25 d ago

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12419937	Mar 07, 2033	in 6 yr 6 mo	U-3726
11278599	Mar 07, 2033	in 6 yr 6 mo	U-3726
10512677	Mar 07, 2033	in 6 yr 6 mo	U-3726
11753632	Sep 30, 2035	in 9 yr 1 mo	U-3726
10961522	Sep 30, 2035	in 9 yr 1 mo	U-3726
10208299	Sep 30, 2035	in 9 yr 1 mo	SubstanceProductU-3726
12414985	Dec 29, 2036	in 10 yr 4 mo	U-3726
11278601	Dec 29, 2036	in 10 yr 4 mo	ProductU-3726
10857212	Aug 12, 2037	in 11 yr	U-3726
12246062	Sep 16, 2038	in 12 yr 1 mo	U-3726

Approval history

FDA approval span

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First approval

Jul 31, 2003

23 yr 7 mo ago

Most recent approval

Mar 14, 2025

1 yr 8 mo ago

Approvals span 2003–2025 across 6 FDA applications.

Brand (NDA) 233%

Generic (ANDA) 467%

Miglustat: 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.

Related FDA reference tools

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