LOMUSTINE - Generic Drug Details
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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: | 107 |
| Patent Applications: | 7,373 |
| 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 |
|---|---|
| Istari Oncology, Inc. | Phase 2 |
| Darell Bigner | Phase 2 |
| CarThera | Phase 3 |
Pharmacology for LOMUSTINE
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for LOMUSTINE
Anatomical Therapeutic Chemical (ATC) Classes for LOMUSTINE
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 | 017588-003 | Approved Prior to Jan 1, 1982 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Latina Pharma | GLEOSTINE | lomustine | CAPSULE;ORAL | 017588-001 | Approved Prior to Jan 1, 1982 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Latina Pharma | GLEOSTINE | lomustine | CAPSULE;ORAL | 017588-002 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Latina Pharma | GLEOSTINE | lomustine | CAPSULE;ORAL | 017588-004 | Dec 19, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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