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SELEGILINE HYDROCHLORIDE Drug Profile
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» See Plans and PricingWhen do Selegiline Hydrochloride patents expire, and what generic alternatives are available?
Selegiline Hydrochloride is a drug marketed by Apotex, Dava Pharms Inc, Lannett Co Inc, Rising, Apotex Inc, Boscogen, Chartwell Molecules, Cosette, G And W Labs Inc, MLV, Mylan, and Somerset. and is included in fourteen NDAs.
The generic ingredient in SELEGILINE HYDROCHLORIDE is selegiline hydrochloride. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the selegiline hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Selegiline Hydrochloride
A generic version of SELEGILINE HYDROCHLORIDE was approved as selegiline hydrochloride by APOTEX INC on June 6th, 1997.
Summary for SELEGILINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 14 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 51 |
| Clinical Trials: | 34 |
| Patent Applications: | 586 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | SELEGILINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for SELEGILINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Oxford | N/A |
| University of South Florida | Phase 4 |
| Mood and Anxiety Research, Inc | Phase 3 |
Pharmacology for SELEGILINE HYDROCHLORIDE
| Drug Class | Monoamine Oxidase Inhibitor Monoamine Oxidase Type B Inhibitor |
| Mechanism of Action | Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors |
US Patents and Regulatory Information for SELEGILINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | CAPSULE;ORAL | 075321-001 | Dec 4, 1998 | AB | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Chartwell Molecules | SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | TABLET;ORAL | 074565-001 | Aug 2, 1996 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Rising | SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | CAPSULE;ORAL | 206803-001 | Apr 2, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mlv | SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | TABLET;ORAL | 074672-001 | Apr 1, 1997 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Chartwell Molecules | SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | TABLET;ORAL | 074641-001 | Aug 2, 1996 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
