.

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

AVODART Drug Profile

« Back to Dashboard
Avodart is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from five suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has eighty-two patent family members in thirty-nine countries.

The generic ingredient in AVODART is dutasteride. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dutasteride profile page.

Summary for Tradename: AVODART

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list5
Drug Prices: :see details

Pharmacology for Tradename: AVODART

Clinical Trials for: AVODART

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 2001RXYes5,565,467Nov 20, 2015YY
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: AVODART

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
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,565,467<disabled>
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,998,427<disabled>
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,846,976<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: AVODART

Drugname Dosage Strength RLD Submissiondate
dutasterideCapsules0.5 mgAvodart10/29/2007

Non-Orange Book Patents for Tradename: AVODART

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
5,817,818 Androstenones<disabled in preview>
5,977,126 Androstenones<disabled in preview>
5,846,976 Androstenone derivative<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: AVODART

Country Document Number Estimated Expiration
New Zealand274642<disabled in preview>
Slovakia34796<disabled in preview>
African Intellectual Property Organization (OAPI)10575<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.

Supplementary Protection Certificates for Tradename: AVODART

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB03/018United Kingdom<disabled>PRODUCT NAME: DUTASTERIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SOLVATE.; REGISTERED: SE 17871 20020719; SE 17872 20020719; UK PL 19494/0005 20030117; UK PL 19494/0006 20030117
2003 007, C 0719278 /LLithuania<disabled>
00122Netherlands<disabled>PRODUCT NAME: DUTASTERIDUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT; NAT. REGISTRATION NO/DATE: RVG 28317RVG 28318 2002161216; FIRST REGISTRATION: 1787117872 2002190719
This preview shows a limited data set
Subscribe for full access, or try a Trial

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

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 verifification 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.

`abc