RALOXIFENE HYDROCHLORIDE Drug Patent Profile

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

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

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

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	85
Patent Applications:	3,488
Formulation / Manufacturing:	see details
DailyMed Link:	RALOXIFENE HYDROCHLORIDE at DailyMed

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

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

Bone Density Conservation Agents
Estrogen Antagonists
Selective Estrogen Receptor Modulators

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

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