PROPECIA Drug Patent Profile

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When do Propecia patents expire, and when can generic versions of Propecia launch?

Propecia is a drug marketed by Organon and is included in one NDA.

The generic ingredient in PROPECIA is finasteride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the finasteride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Propecia

A generic version of PROPECIA was approved as finasteride by DR REDDYS LABS INC on July 28^th, 2006.

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Summary for PROPECIA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	10
Patent Applications:	3,500
Drug Prices:	Drug price information for PROPECIA
What excipients (inactive ingredients) are in PROPECIA?	PROPECIA excipients list
DailyMed Link:	PROPECIA at DailyMed

Drug patent expirations by year for PROPECIA

Recent Clinical Trials for PROPECIA

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

Sponsor	Phase
Follicle Pharma Ltd	Phase 1
Inventage Lab., Inc.	Phase 1/Phase 2
Polichem S.A.	Phase 3

See all PROPECIA clinical trials

Pharmacology for PROPECIA

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

US Patents and Regulatory Information for PROPECIA

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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
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	AB	RX	Yes	Yes	⤷ 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 PROPECIA

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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
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

International Patents for PROPECIA

See the table below for patents covering PROPECIA around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	5078793		⤷ Sign Up
Cyprus	2135	New method of preparation of finasteride	⤷ Sign Up
Hungary	216195	Új eljárás finasteride előállítására (NEW MEDHOD FOR THE PRODUCTION OF FINASTEROIDE)	⤷ Sign Up
Spain	2072848		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PROPECIA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0155096	93C0055	Belgium	⤷ Sign Up	PRODUCT NAME: FINASTERIDUM; NAT. REG..: 922 IS 151 F 3 19930125; FIRST REG.: GB PL 0025/0279 19920527
0155096	SPC/GB93/006	United Kingdom	⤷ Sign Up	SPC/GB93/006:, EXPIRES: 20070526
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for PROPECIA

Recent Clinical Trials for PROPECIA

Pharmacology for PROPECIA

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