PEMOLINE - Generic Drug Details
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What are the generic sources for pemoline and what is the scope of patent protection?
Pemoline
is the generic ingredient in two branded drugs marketed by Abbott, Actavis Elizabeth, Teva Pharms, Fosun Pharma, Mallinckrodt, Vintage Pharms, and Watson Labs, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for pemoline.
Summary for PEMOLINE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 10 |
| Drug Master File Entries: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 45 |
| Clinical Trials: | 5 |
| Patent Applications: | 5,270 |
| DailyMed Link: | PEMOLINE at DailyMed |
Recent Clinical Trials for PEMOLINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical University of Vienna | Phase 2 |
| California Pacific Medical Center Research Institute | Phase 2 |
| Sheba Medical Center | N/A |
Medical Subject Heading (MeSH) Categories for PEMOLINE
Anatomical Therapeutic Chemical (ATC) Classes for PEMOLINE
US Patents and Regulatory Information for PEMOLINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fosun Pharma | PEMOLINE | pemoline | TABLET;ORAL | 075286-002 | Jun 30, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms | PEMOLINE | pemoline | TABLET;ORAL | 075030-001 | Jan 29, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms | PEMOLINE | pemoline | TABLET;ORAL | 075030-002 | Jan 29, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbott | CYLERT | pemoline | TABLET;ORAL | 016832-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms | PEMOLINE | pemoline | TABLET;ORAL | 075030-003 | Feb 22, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mallinckrodt | PEMOLINE | pemoline | TABLET;ORAL | 075726-003 | Mar 30, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Actavis Elizabeth | PEMOLINE | pemoline | TABLET;ORAL | 075595-003 | Feb 28, 2000 | DISCN | No | 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 |
