Lomustine - Generic Drug Details

What are the generic sources for lomustine and what is the scope of patent protection?

Lomustine is the generic ingredient in one branded drug marketed by Latina Pharma and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for lomustine. One supplier is listed for this compound.

Summary for lomustine

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	106
Patent Applications:	7,373
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in lomustine?	lomustine excipients list
DailyMed Link:	lomustine at DailyMed

Recent Clinical Trials for lomustine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
CarThera	Phase 3
University of Iowa	N/A
Varun Monga, MD	N/A

See all lomustine clinical trials

Pharmacology for lomustine

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for lomustine

Antineoplastic Agents, Alkylating

US Patents and Regulatory Information for lomustine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Latina Pharma	GLEOSTINE	lomustine	CAPSULE;ORAL	017588-004	Dec 19, 2014		DISCN	Yes	No
Latina Pharma	GLEOSTINE	lomustine	CAPSULE;ORAL	017588-002	Approved Prior to Jan 1, 1982		RX	Yes	No
Latina Pharma	GLEOSTINE	lomustine	CAPSULE;ORAL	017588-003	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Latina Pharma	GLEOSTINE	lomustine	CAPSULE;ORAL	017588-001	Approved Prior to Jan 1, 1982		RX	Yes	No