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, Bionpharma, Heritage Pharms Inc, Hikma, Humanwell Puracap, Mylan, Nostrum Labs Inc, Rising, Strides Pharma, Vintage, Zydus Lifesciences, Anchen Pharms, and Zydus Pharms. and is included in twenty-two NDAs.
The generic ingredient in DUTASTERIDE is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Four 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 ANCHEN PHARMS on February 26th, 2014.
Summary for DUTASTERIDE
| US Patents: | 0 |
| Applicants: | 20 |
| NDAs: | 22 |
| Finished Product Suppliers / Packagers: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 111 |
| Patent Applications: | 4,383 |
| Formulation / Manufacturing: | see details |
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Vintage | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 202421-001 | Nov 20, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma Ltd | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 202660-001 | Nov 20, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amneal Pharms | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 203118-001 | Nov 20, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Humanwell Puracap | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 209909-001 | Nov 21, 2017 | AB | RX | No | No | ⤷ 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 |
