RASAGILINE MESYLATE - Generic Drug Details
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What are the generic drug sources for rasagiline mesylate and what is the scope of freedom to operate?
Rasagiline mesylate
is the generic ingredient in two branded drugs marketed by Teva, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Usa, Carnegie, Chartwell Rx, Indoco, Macleods Pharms Ltd, Micro Labs, Orbion Pharms, Skg Pharma, and Watson Labs Inc, and is included in twelve NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Rasagiline mesylate has twenty-six patent family members in eighteen countries.
There are eighteen drug master file entries for rasagiline mesylate. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for RASAGILINE MESYLATE
International Patents: | 26 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 12 |
NDAs: | 12 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 14 |
Patent Applications: | 327 |
Drug Prices: | Drug price trends for RASAGILINE MESYLATE |
What excipients (inactive ingredients) are in RASAGILINE MESYLATE? | RASAGILINE MESYLATE excipients list |
DailyMed Link: | RASAGILINE MESYLATE at DailyMed |
Recent Clinical Trials for RASAGILINE MESYLATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Teva Branded Pharmaceutical Products R&D, Inc. | Phase 1 |
Teva Pharmaceutical Industries | Phase 1 |
Teva Pharmaceutical Industries | Phase 4 |
Generic filers with tentative approvals for RASAGILINE MESYLATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 1MG BASE | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 0.5MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for RASAGILINE MESYLATE
Drug Class | Monoamine Oxidase Inhibitor |
Mechanism of Action | Monoamine Oxidase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for RASAGILINE MESYLATE
Paragraph IV (Patent) Challenges for RASAGILINE MESYLATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AZILECT | Tablets | rasagiline mesylate | 0.5 mg and 1 mg | 021641 | 5 | 2010-05-17 |
US Patents and Regulatory Information for RASAGILINE MESYLATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chartwell Rx | RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 201892-002 | Jul 27, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Indoco | RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 206153-002 | Oct 4, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Skg Pharma | RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 218163-001 | Apr 9, 2024 | AB | RX | 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 |
Expired US Patents for RASAGILINE MESYLATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-001 | May 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-001 | May 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-002 | May 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RASAGILINE MESYLATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 244802 | פורמולציות של רסאג'ילין בעלות אחידות תוכן משופרת (Rasagiline formulations of improved content uniformity) | ⤷ Sign Up |
South Africa | 200707469 | Rasagiline formulations of improved content uniformity | ⤷ Sign Up |
South Korea | 20140103356 | RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RASAGILINE MESYLATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0812190 | SPC/GB05/042 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MESYLATE, ESYLATE OR SULFATE SALTS OF N-PROPARGYL-1(R)-AMINOINDAN (RASAGILINE); REGISTERED: UK EU/1/04/304/001 20050221; UK EU/1/04/304/002 20050221; UK EU/1/04/304/003 20050221; UK EU/1/04/304/004 20050221; UK EU/1/04/304/005 20050221; UK EU/1/04/304/006 20050221; UK EU/1/04/304/007 20050221 |
0812190 | C300205 | Netherlands | ⤷ Sign Up | PRODUCT NAME: RASAGILINE, DESGEWENST IN DE VORM VAN EENFARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/04/304/001 T/M 007 20050221 |
0812190 | 05C0033 | France | ⤷ Sign Up | PRODUCT NAME: RASAGILINE; NAT. REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221; FIRST REGISTRATION: EU/1/4/304/001-007 20050221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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