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AZILECT Drug Profile

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Azilect is a drug marketed by Teva and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eleven patent family members in thirty-four countries.

The generic ingredient in AZILECT is rasagiline mesylate. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the rasagiline mesylate profile page.

Summary for Tradename: AZILECT

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Drug Prices: :see details

Pharmacology for Tradename: AZILECT

Clinical Trials for: AZILECT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006RXNo5,453,446Feb 7, 2017
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006RXYes7,815,942Aug 27, 2027YY
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006RXNo7,572,834Dec 5, 2026Y
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Expired Patents for Tradename: AZILECT

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 20066,126,968<disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 20065,387,612<disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 20065,457,133<disabled>
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Paragraph IV activity for: AZILECT

Drugname Dosage Strength RLD Submissiondate
rasagiline mesylateTablets0.5 mg and 1 mgAzilect5/17/2010

Non-Orange Book Patents for Tradename: AZILECT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,598,420Rasagiline formulations and processes for their preparation<disabled in preview>
5,387,612 Use of the R-enantiomers of N-propargyl-1-aminoindan compounds for treating Parkinson's disease<disabled in preview>
5,744,500 Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: AZILECT

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9637199<disabled in preview>
Japan2013139452<disabled in preview>
Denmark0812190<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AZILECT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0033France<disabled>PRODUCT NAME: RASAGILINE; NAT. REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221; FIRST REGISTRATION: EU/1/4/304/001-007 20050221
00205Netherlands<disabled>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
2005 00040Denmark<disabled>
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