GLEOSTINE Drug Patent Profile
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Which patents cover Gleostine, and what generic alternatives are available?
Gleostine is a drug marketed by Latina Pharma and is included in one NDA.
The generic ingredient in GLEOSTINE is lomustine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lomustine profile page.
Summary for GLEOSTINE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 116 |
| Clinical Trials: | 13 |
| Patent Applications: | 5,190 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GLEOSTINE |
| What excipients (inactive ingredients) are in GLEOSTINE? | GLEOSTINE excipients list |
| DailyMed Link: | GLEOSTINE at DailyMed |
Recent Clinical Trials for GLEOSTINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NRG Oncology | Phase 3 |
| National Cancer Institute (NCI) | Phase 3 |
| Emory University | Early Phase 1 |
Pharmacology for GLEOSTINE
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for GLEOSTINE
US Patents and Regulatory Information for GLEOSTINE
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Latina Pharma | GLEOSTINE | lomustine | CAPSULE;ORAL | 017588-003 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Latina Pharma | GLEOSTINE | lomustine | CAPSULE;ORAL | 017588-001 | Approved Prior to Jan 1, 1982 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
