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Last Updated: March 29, 2024

Dutasteride - Generic Drug Details


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What are the generic sources for dutasteride and what is the scope of freedom to operate?

Dutasteride is the generic ingredient in four branded drugs marketed by Woodward, 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-four NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for dutasteride. Seventeen suppliers are listed for this compound.

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Drug Sales Revenue Trends for dutasteride

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Recent Clinical Trials for dutasteride

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SponsorPhase
Masonic Cancer Center, University of MinnesotaPhase 2
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalPhase 2
Radboud University Medical CenterPhase 2

See all dutasteride clinical trials

Pharmacology for dutasteride
Medical Subject Heading (MeSH) Categories 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
Mylan DUTASTERIDE dutasteride CAPSULE;ORAL 203241-001 Jun 14, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vintage DUTASTERIDE dutasteride CAPSULE;ORAL 202421-001 Nov 20, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heritage Pharms Inc DUTASTERIDE dutasteride CAPSULE;ORAL 207935-001 Oct 13, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Barr DUTASTERIDE dutasteride CAPSULE;ORAL 090095-001 Dec 21, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Woodward JALYN dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 022460-001 Jun 14, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Woodward AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nostrum Labs Inc DUTASTERIDE dutasteride CAPSULE;ORAL 204705-001 Nov 20, 2015 DISCN 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

Expired US Patents for dutasteride

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

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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.