AVODART Drug Patent Profile
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When do Avodart patents expire, and what generic alternatives are available?
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.
Summary for AVODART
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 92 |
Clinical Trials: | 39 |
Patent Applications: | 3,998 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AVODART |
What excipients (inactive ingredients) are in AVODART? | AVODART excipients list |
DailyMed Link: | AVODART at DailyMed |
Recent Clinical Trials for AVODART
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Radboud University Medical Center | Phase 2 |
Dongkook Pharmaceutical Co., Ltd. | Phase 3 |
Addpharma Inc. | Phase 1 |
Pharmacology for AVODART
Drug Class | 5-alpha Reductase Inhibitor |
Mechanism of Action | 5-alpha Reductase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|
Spain | 2140181 | ⤷ Try a Trial | |
Iceland | 4206 | ⤷ Try a Trial | |
Czech Republic | 9600745 | ⤷ Try a Trial | |
Russian Federation | 2144037 | ANDROSTEN(ANE) (ONE) DERIVATIVES OR PHARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF, METHODS OF PREPARATION THEREOF, AND METHOD OF MEDICAL TREATMENT | ⤷ Try a Trial |
Finland | 115216 | ⤷ 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 | 300122 | Netherlands | ⤷ Try a Trial | |
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 |
0719278 | SPC009/2005 | Ireland | ⤷ Try a Trial | SPC009/2005: 20060316, EXPIRES: 20170718 |
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 | SPC/GB03/018 | United Kingdom | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |