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Last Updated: March 29, 2024

AVODART Drug Patent Profile


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Which patents cover Avodart, and when can generic versions of Avodart launch?

Avodart is a drug marketed by Woodward and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Avodart

A generic version of AVODART was approved as dutasteride by BARR on December 21st, 2010.

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Drug patent expirations by year for AVODART
Drug Prices for AVODART

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Drug Sales Revenue Trends for AVODART

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Recent Clinical Trials for AVODART

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Radboud University Medical CenterPhase 2
Dongkook Pharmaceutical Co., Ltd.Phase 3
Addpharma Inc.Phase 1

See all AVODART clinical trials

Pharmacology for AVODART
Paragraph IV (Patent) Challenges for AVODART
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AVODART Capsules dutasteride 0.5 mg 021319 1 2007-10-29

US Patents and Regulatory Information for AVODART

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Woodward AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 AVODART

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Woodward AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001 ⤷  Try a Trial ⤷  Try a Trial
Woodward AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001 ⤷  Try a Trial ⤷  Try a Trial
Woodward AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AVODART

See the table below for patents covering AVODART around the world.

Country Patent Number Title Estimated Expiration
Germany 69407978 ⤷  Try a Trial
Canada 2462061 ⤷  Try a Trial
New Zealand 274059 4-AZA-17-CARBAMOYL-3-OXOANDROST-1-ENE DERIVATIVES, ANDROST-4-ENE- OR -4-ANE- DERIVATIVES AS INTERMEDIATES ⤷  Try a Trial
South Africa 9407118 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AVODART

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0719278 03C0030 France ⤷  Try a Trial PRODUCT NAME: DUTASTERIDE; NAT. REGISTRATION NO/DATE: NL 28 131 20030327; FIRST REGISTRATION: SE - 17 871 20020719
0719278 300122 Netherlands ⤷  Try a Trial
0719278 23/2003 Austria ⤷  Try a Trial PRODUCT NAME: DUTASTERIDE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SOLVATES; NAT. REGISTRATION NO/DATE: 1-24844, 1-24845 20030217; FIRST REGISTRATION: SE 17871, 17872 20020719
0719278 C300122 Netherlands ⤷  Try a Trial PRODUCT NAME: DUTASTERIDUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT; NAT. REGISTRATION NO/DATE: RVG 28317RVG 28318 2002161216; FIRST REGISTRATION: 1787117872 2002190719
>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.