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 Waylis Therap 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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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 |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Iceland | 4205 | ⤷ Sign Up | |
| Germany | 69407978 | ⤷ Sign Up | |
| Croatia | P940563 | ANDROSTENONE DERIVATIVES | ⤷ Sign Up |
| Canada | 2170047 | DERIVE DE L'ANDROSTENONE (ANDROSTENONE DERIVATIVE) | ⤷ Sign Up |
| Norway | 961085 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | |
| 0719278 | PA 2003 007, C 0719278 /L | Lithuania | ⤷ Sign Up | |
| 0719278 | 23/2003 | Austria | ⤷ Sign Up | 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 | SPC009/2005 | Ireland | ⤷ Sign Up | SPC009/2005: 20060316, EXPIRES: 20170718 |
| 0719278 | PA2003007 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DUTASTERIDUM (17BETA-N(2,5-BIS(TRIFLUORMETIL)FENILKARBAMOIL-4-AZA-5ALFA-ANDROST-1-EN-3-ONAS), PASIRINKTINAI FARMACISKAI TINKAMO SOLVATO FORMOJE; REGISTRATION NO/DATE: 03/8183/7 20030909 |
| >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.
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