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Dutasteride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dutasteride?

Dutasteride is the generic ingredient in four branded drugs marketed by West-ward Pharms Int, Breckenridge Pharm, Actavis Labs Fl Inc, Amneal Pharms, Glaxosmithkline, Vintage Pharms Llc, Rising Pharms Inc, Mylan Pharms Inc, Aurolife Pharma Llc, Strides Pharma, Intergel Pharms Inc, Ascent Pharms Inc, Apotex Inc, Barr, Bionpharma Inc, and Anchen Pharms, and is included in eighteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for dutasteride. Twenty suppliers are listed for this compound.

Summary for Generic Name: dutasteride

Tradenames:4
Patents:1
Applicants:16
NDAs:18
Drug Master File Entries: see list17
Suppliers / Packagers: see list20
Bulk Api Vendors: see list49
Clinical Trials: see list18
Patent Applications: see list2,336
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dutasteride at DailyMed

Pharmacology for Ingredient: dutasteride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vintage Pharms Llc
DUTASTERIDE
dutasteride
CAPSULE;ORAL202421-001Nov 20, 2015RXNoNo► Subscribe► Subscribe
Actavis Labs Fl Inc
DUTASTERIDE
dutasteride
CAPSULE;ORAL202808-001Nov 20, 2015RXNoNo► Subscribe► Subscribe
Breckenridge Pharm
DUTASTERIDE
dutasteride
CAPSULE;ORAL204705-001Nov 20, 2015RXNoNo► Subscribe► Subscribe
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 2001RXYesYes► Subscribe► Subscribe
Actavis Labs Fl Inc
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202975-001Nov 20, 2015RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dutasteride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,565,467► Subscribe
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,846,976► Subscribe
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,998,427► Subscribe
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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 verifification 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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