.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

TEMODAR Drug Profile

« Back to Dashboard
Temodar is a drug marketed by Merck Sharp Dohme and is included in two NDAs. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-three countries.

The generic ingredient in TEMODAR is temozolomide. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the temozolomide profile page.

Summary for Tradename: TEMODAR

Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list2

Pharmacology for Tradename: TEMODAR

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

Clinical Trials for: TEMODAR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-001Aug 11, 1999RXNo<disabled><disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
POWDER;INTRAVENOUS022277-001Feb 27, 2009RXYes6,987,108<disabled>Y <disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-005Oct 19, 2006RXNo<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: TEMODAR

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-001Aug 11, 19995,260,291*PED<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-005Oct 19, 20065,260,291*PED<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-003Aug 11, 19995,260,291*PED<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV activity for: TEMODAR

Drugname Dosage Strength RLD Submissiondate
temozolomideCapsules140 mg and 180 mgTemodar3/24/2008

Non-Orange Book Patents for Tradename: TEMODAR

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
7,674,790Processes of making and using pharmaceutical formulations of antineoplastic agents<disabled in preview>
8,076,335Processes of making pharmaceutical formulations of antineoplastic agents<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: TEMODAR

Country Document Number Estimated Expiration
Argentina064722<disabled in preview>
China1635871<disabled in preview>
World Intellectual Property Organization (WIPO)03072082<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

`abc