Is there a generic for Lomustine?

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

What is the reference-listed drug for Lomustine?

GLEOSTINE (NDA 017588, AZURITY) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

Does Lomustine have FDA marketing exclusivity?

Yes. The Orange Book records 3 marketing-exclusivity periods for Lomustine. 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 Lomustine are approved?

Lomustine is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Lomustine

Lomustine: 1 brand, 1 generic; first approved Dec 19, 2014; generic available.

Generic available3 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 1 ANDA application approved.

Latest exclusivity ends May 19, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

GLEOSTINERLD
AZURITYNDA 01758820144 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG CAPSULE ORAL Rx AB
40MG CAPSULE ORAL Rx AB
100MG CAPSULE ORAL Rx AB
5MG CAPSULE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE	ORAL	Rx	AB
40MG	CAPSULE	ORAL	Rx	AB
100MG	CAPSULE	ORAL	Rx	AB
5MG	CAPSULE	ORAL	Discontinued	—

Generic (ANDA) products (1)

Abbreviated applications

LOMUSTINE
CARNEGIEANDA 21926520253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG CAPSULE ORAL Rx AB
40MG CAPSULE ORAL Rx AB
100MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE	ORAL	Rx	AB
40MG	CAPSULE	ORAL	Rx	AB
100MG	CAPSULE	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

CGTFDA marketing exclusivity
May 19, 2026
5 mo ago
CGTFDA marketing exclusivity
May 19, 2026
5 mo ago
CGTFDA marketing exclusivity
May 19, 2026
5 mo ago

Listed patents

Orange Book patent file

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.

Approval history

FDA approval span

First approval

Dec 19, 2014

12 yr ago

Most recent approval

Oct 27, 2025

1 yr ago

Approvals span 2014–2025 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Lomustine: 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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