Finasteride - Generic Drug Details

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What are the generic sources for finasteride and what is the scope of patent protection?

Finasteride is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Actavis Totowa, Actavis Totowa Teva, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Gedeon Richter Usa, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Mylan, Natco Pharma, Sun Pharm, Teva, Zydus Pharms Usa Inc, Organon, Blue Water Biotech, and Zydus Lifesciences, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for finasteride. Thirty-five suppliers are listed for this compound.

Summary for finasteride

US Patents:	0
Tradenames:	5
Applicants:	20
NDAs:	26
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	78
Patent Applications:	7,314
Drug Prices:	Drug price trends for finasteride
Drug Sales Revenues:	Drug sales revenues for finasteride
What excipients (inactive ingredients) are in finasteride?	finasteride excipients list
DailyMed Link:	finasteride at DailyMed

See drug prices for finasteride

Drug Sales Revenue Trends for finasteride

See drug sales revenues for finasteride

Recent Clinical Trials for finasteride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Follicle Pharma Ltd	Phase 1
Mohammed Abd El Mawgoud Amer	N/A
Vanderbilt University Medical Center	Phase 2

See all finasteride clinical trials

Pharmacology for finasteride

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

Medical Subject Heading (MeSH) Categories for finasteride

5-alpha Reductase Inhibitors
Urological Agents

Anatomical Therapeutic Chemical (ATC) Classes for finasteride

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

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

US Patents and Regulatory Information for finasteride

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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
Dr Reddys Labs Inc	FINASTERIDE	finasteride	TABLET;ORAL	076436-001	Jul 28, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipla	FINASTERIDE	finasteride	TABLET;ORAL	077335-001	Nov 20, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	FINASTERIDE	finasteride	TABLET;ORAL	204304-001	Jan 5, 2017	AB	RX	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 finasteride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	⤷ Sign Up	⤷ Sign Up
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	⤷ Sign Up	⤷ Sign Up
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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