DUTASTERIDE - Generic Drug Details

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

Dutasteride is the generic ingredient in four branded drugs marketed by Waylis Therap, 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-five 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.

Summary for DUTASTERIDE

US Patents:	0
Tradenames:	4
Applicants:	22
NDAs:	25
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	111
Patent Applications:	6,261
Drug Prices:	Drug price trends for DUTASTERIDE
What excipients (inactive ingredients) are in DUTASTERIDE?	DUTASTERIDE excipients list
DailyMed Link:	DUTASTERIDE at DailyMed

See drug prices for DUTASTERIDE

Drug Sales Revenue Trends for DUTASTERIDE

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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

See all DUTASTERIDE clinical trials

Pharmacology for DUTASTERIDE

Drug Class	5-alpha Reductase Inhibitor
Mechanism of Action	5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for DUTASTERIDE

5-alpha Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DUTASTERIDE

G04CB	Testosterone-5-alpha reductase inhibitors
G04C	DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Humanwell Puracap	DUTASTERIDE	dutasteride	CAPSULE;ORAL	209909-001	Nov 21, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	202509-001	Feb 26, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DUTASTERIDE	dutasteride	CAPSULE;ORAL	202204-001	Nov 23, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nostrum Labs Inc	DUTASTERIDE	dutasteride	CAPSULE;ORAL	204705-001	Nov 20, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	DUTASTERIDE	dutasteride	CAPSULE;ORAL	202530-001	Nov 20, 2015		DISCN	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

Expired US Patents for DUTASTERIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001	⤷ Sign Up	⤷ Sign Up
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001	⤷ Sign Up	⤷ Sign Up
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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