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, Strides Softgels, 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?
- What are the global sales for DUTASTERIDE?
- What is Average Wholesale Price for DUTASTERIDE?
Summary for DUTASTERIDE
US Patents: | 0 |
Applicants: | 22 |
NDAs: | 23 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 92 |
Clinical Trials: | 111 |
Patent Applications: | 4,209 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Vintage | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 202421-001 | Nov 20, 2015 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Aurobindo Pharma Ltd | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 202660-001 | Nov 20, 2015 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Amneal Pharms | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 203118-001 | Nov 20, 2015 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Acella | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 206373-001 | Mar 17, 2016 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Humanwell Puracap | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 209909-001 | Nov 21, 2017 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Market Dynamics and Financial Trajectory for Dutasteride
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