SELEGILINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for selegiline hydrochloride and what is the scope of freedom to operate?
Selegiline hydrochloride
is the generic ingredient in three branded drugs marketed by Somerset, Apotex, Lannett Co Inc, Novitium Pharma, Rising, Bausch, Apotex Inc, Bayshore Pharms Llc, Chartwell Molecules, Cosette, Dash Pharms Natco, G And W Labs Inc, and I3 Pharms, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.There are twelve drug master file entries for selegiline hydrochloride. Eleven suppliers are listed for this compound.
Summary for SELEGILINE HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 13 |
| NDAs: | 16 |
| Drug Master File Entries: | 12 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 38 |
| Patent Applications: | 969 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in SELEGILINE HYDROCHLORIDE? | SELEGILINE HYDROCHLORIDE excipients list |
| DailyMed Link: | SELEGILINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for SELEGILINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Ibadan | Phase 1/Phase 2 |
| László Mangel | Phase 2 |
| E-Group ICT Software Informatikai Zrt. | Phase 2 |
Pharmacology for SELEGILINE HYDROCHLORIDE
| Drug Class | Monoamine Oxidase Inhibitor Monoamine Oxidase Type B Inhibitor |
| Mechanism of Action | Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for SELEGILINE HYDROCHLORIDE
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | TABLET;ORAL | 074744-001 | Jan 27, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex Inc | SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | TABLET;ORAL | 074871-001 | Jun 6, 1997 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | CAPSULE;ORAL | 206803-001 | Apr 2, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bausch | ZELAPAR | selegiline hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021479-001 | Jun 14, 2006 | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for SELEGILINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | ZELAPAR | selegiline hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021479-001 | Jun 14, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | ZELAPAR | selegiline hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021479-001 | Jun 14, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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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