Rasagiline mesylate - Generic Drug Details
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What are the generic 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, Micro Labs, Orbion Pharms, and Watson Labs Inc, and is included in ten 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. Eight 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: | 10 |
NDAs: | 10 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 14 |
Patent Applications: | 327 |
Formulation / Manufacturing: | see details |
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 Pharmaceutical Industries | Phase 1 |
Teva Branded Pharmaceutical Products R&D, Inc. | Phase 1 |
Teva Branded Pharmaceutical Products R&D, Inc. | Phase 4 |
Generic filers with tentative approvals for RASAGILINE MESYLATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | EQ 1MG BASE | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 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 |
US Patents and Regulatory Information for rasagiline mesylate
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-002 | May 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-001 | May 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-001 | May 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-001 | May 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-001 | May 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for rasagiline mesylate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2404746 | КОМПОЗИЦИИ РАЗАГИЛИНА С УЛУЧШЕННОЙ ОДНОРОДНОСТЬЮ СОДЕРЖИМОГО (COMPOSITIONS OF RASAGILINE WITH IMPROVED HOMOGENEITY OF CONTENT) | ⤷ Try a Trial |
Japan | 5738509 | ⤷ Try a Trial | |
South Africa | 200707469 | Rasagiline formulations of improved content uniformity | ⤷ Try a Trial |
Spain | 2586412 | ⤷ Try a Trial | |
Norway | 20074823 | ⤷ Try a Trial | |
European Patent Office | 1848402 | PREPARATIONS DE RASAGILINE PRESENTANT UNE UNIFORMITE DE TENEUR AMELIOREE (RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for rasagiline mesylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0812190 | 05C0033 | France | ⤷ Try a Trial | PRODUCT NAME: RASAGILINE; NAT. REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221; FIRST REGISTRATION: EU/1/4/304/001-007 20050221 |
0812190 | C300205 | Netherlands | ⤷ Try a Trial | 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 | 31/2005 | Austria | ⤷ Try a Trial | PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221 |
0812190 | SPC/GB05/042 | United Kingdom | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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