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Details for Patent: RE41065

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Patent RE41065 protects TARCEVA and is included in one NDA. There has been one Paragraph IV challenge on Tarceva.

Protection for TARCEVA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty-seven patent family members in forty-one countries.

Summary for Patent: RE41065

Title:Alkynl and azido-substituted 4-anilinoquinazolines
Abstract:The invention relates to compounds of the formula ##STR00001## and to pharmaceutically acceptable salts thereof, wherein R.sup.1, R.sup.2, R.sup.3, R.sup.4, n and m are as defined herein. The compounds of formula I are useful in the treatment of hyperproliferative diseases, such as cancer. The invention further relates to processes of making the compounds of formula I and to methods of using such compounds in the treatment of hyperproliferative diseases.
Inventor(s): Schnur; Rodney Caughren (Noank, CT), Arnold; Lee Daniel (Mt. Sinai, NY)
Assignee: Pfizer, Inc. (New York, NY) OSI Pharmaceuticals, Inc. (Melville, NY)
Application Number:12/038,530
Patent Claim Types:
see list of patent claims
Compound; Use; Composition; Process;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-001Nov 18, 2004RXNoRE41065*PED► subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-002Nov 18, 2004RXNoRE41065*PED► subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-003Nov 18, 2004RXYesRE41065*PED► subscribe
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Non-Orange Book Patents for Patent: RE41065

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
5,747,498 Alkynyl and azido-substituted 4-anilinoquinazolines► subscribe
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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 Patent: RE41065

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO)735► subscribe
African Regional IP Organization (ARIPO)9600788► subscribe
Argentina002723► subscribe
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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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