AZILECT Drug Patent Profile
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When do Azilect patents expire, and what generic alternatives are available?
Azilect is a drug marketed by Teva and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-six patent family members in eighteen countries.
The generic ingredient in AZILECT is rasagiline mesylate. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Azilect
A generic version of AZILECT was approved as rasagiline mesylate by ORBION PHARMS on March 15th, 2016.
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Summary for AZILECT
| International Patents: | 26 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 212 |
| Clinical Trials: | 27 |
| Patent Applications: | 4,839 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AZILECT |
| What excipients (inactive ingredients) are in AZILECT? | AZILECT excipients list |
| DailyMed Link: | AZILECT at DailyMed |
Recent Clinical Trials for AZILECT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | Phase 2 |
| University of Florida | Phase 2 |
| Thomas Guttuso |
Pharmacology for AZILECT
| Drug Class | Monoamine Oxidase Inhibitor |
| Mechanism of Action | Monoamine Oxidase Inhibitors |
Paragraph IV (Patent) Challenges for AZILECT
| 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 AZILECT
AZILECT is protected by two US patents.
Patents protecting AZILECT
Rasagiline formulations and processes for their preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Rasagiline formulations of improved content uniformity
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PARKINSON'S DISEASE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-001 | May 16, 2006 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-002 | May 16, 2006 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-001 | May 16, 2006 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 AZILECT
| 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 AZILECT
See the table below for patents covering AZILECT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Ireland | 904376 | ⤷ Sign Up | |
| Austria | 284208 | ⤷ Sign Up | |
| Canada | 2232310 | COMPOSITIONS STABLES CONTENANT DU N-PROPARGYL-1-AMINOINDANE (STABLE COMPOSITIONS CONTAINING N-PROPARGYL-1-AMINOINDAN) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AZILECT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0436492 | CA 2005 00040 | Denmark | ⤷ Sign Up | |
| 0812190 | 31/2005 | Austria | ⤷ Sign Up | PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 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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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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