RALOXIFENE HYDROCHLORIDE Drug Patent Profile

Which patents cover Raloxifene Hydrochloride, and when can generic versions of Raloxifene Hydrochloride launch?

Raloxifene Hydrochloride is a drug marketed by Amneal Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Glenmark Pharms Ltd, Invagen Pharms, Sciegen Pharms, Teva Pharms Usa, and Watson Labs Inc. and is included in eight NDAs.

The generic ingredient in RALOXIFENE HYDROCHLORIDE is raloxifene hydrochloride. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the raloxifene hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Raloxifene Hydrochloride

A generic version of RALOXIFENE HYDROCHLORIDE was approved as raloxifene hydrochloride by TEVA PHARMS USA on March 4^th, 2014.

Summary for RALOXIFENE HYDROCHLORIDE

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	89
Patent Applications:	4,560
DailyMed Link:	RALOXIFENE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for RALOXIFENE HYDROCHLORIDE

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

Sponsor	Phase
Beth Israel Deaconess Medical Center	PHASE2
Marmara University	PHASE4
Egymedicalpedia	NA

See all RALOXIFENE HYDROCHLORIDE clinical trials

Pharmacology for RALOXIFENE HYDROCHLORIDE

Drug Class	Estrogen Agonist/Antagonist
Mechanism of Action	Selective Estrogen Receptor Modulators

Medical Subject Heading (MeSH) Categories for RALOXIFENE HYDROCHLORIDE

Bone Density Conservation Agents

Estrogen Antagonists

Selective Estrogen Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for RALOXIFENE HYDROCHLORIDE

G03XC	Selective estrogen receptor modulators
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for RALOXIFENE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	208206-001	Apr 8, 2016	AB	RX	No	No
Teva Pharms Usa	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	078193-001	Mar 4, 2014	AB	RX	No	No
Glenmark Pharms Ltd	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	204491-001	Mar 22, 2016	AB	RX	No	No
Watson Labs Inc	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	200825-001	Jan 21, 2015	AB	RX	No	No
Aurobindo Pharma	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	204310-001	Aug 28, 2015	AB	RX	No	No
Cadila Pharms Ltd	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	211324-001	Aug 18, 2020	AB	RX	No	No
Sciegen Pharms	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	206384-001	Oct 12, 2016	AB	RX	No	No