DUTASTERIDE Drug Patent Profile
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When do Dutasteride patents expire, and when can generic versions of Dutasteride launch?
Dutasteride is a drug marketed by Acella, Actavis Labs Fl Inc, Adaptis, Amneal Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Barr, Chartwell, Heritage Pharms Inc, Hikma, Humanwell Puracap, Norvium Bioscience, Nostrum Labs Inc, Rising, Strides Pharma, Vintage, Zydus Lifesciences, Aurobindo Pharma, Endo Operations, and Zydus Pharms. and is included in twenty-three NDAs.
The generic ingredient in DUTASTERIDE is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dutasteride
A generic version of DUTASTERIDE was approved as dutasteride; tamsulosin hydrochloride by ENDO OPERATIONS on February 26th, 2014.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for DUTASTERIDE?
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- What is Average Wholesale Price for DUTASTERIDE?
Summary for DUTASTERIDE
| US Patents: | 0 |
| Applicants: | 21 |
| NDAs: | 23 |
| Finished Product Suppliers / Packagers: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 111 |
| Patent Applications: | 3,998 |
| Drug Prices: | Drug price information for DUTASTERIDE |
| DailyMed Link: | DUTASTERIDE at DailyMed |
See drug prices for DUTASTERIDE
Recent Clinical Trials for DUTASTERIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Masonic Cancer Center, University of Minnesota | Phase 2 |
| Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | Phase 2 |
| Radboud University Medical Center | Phase 2 |
Pharmacology for DUTASTERIDE
| Drug Class | 5-alpha Reductase Inhibitor |
| Mechanism of Action | 5-alpha Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for DUTASTERIDE
Anatomical Therapeutic Chemical (ATC) Classes for DUTASTERIDE
Paragraph IV (Patent) Challenges for DUTASTERIDE
| 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 DUTASTERIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acella | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 206373-001 | Mar 17, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Vintage | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 202421-001 | Nov 20, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma Ltd | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 202660-001 | Nov 20, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal Pharms | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 203118-001 | Nov 20, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Humanwell Puracap | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 209909-001 | Nov 21, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actavis Labs Fl Inc | DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | dutasteride; tamsulosin hydrochloride | CAPSULE;ORAL | 202975-001 | Nov 20, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Barr | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 090095-001 | Dec 21, 2010 | AB | RX | No | No | ⤷ 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 |
