Raloxifene hydrochloride - Generic Drug Details

What are the generic sources for raloxifene hydrochloride and what is the scope of freedom to operate?

Raloxifene hydrochloride is the generic ingredient in two branded drugs marketed by Lilly, 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 nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for raloxifene hydrochloride. Eighteen suppliers are listed for this compound.

Summary for raloxifene hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	86
Patent Applications:	5,717
What excipients (inactive ingredients) are in raloxifene hydrochloride?	raloxifene hydrochloride excipients list
DailyMed Link:	raloxifene hydrochloride at DailyMed

Recent Clinical Trials for raloxifene hydrochloride

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

Sponsor	Phase
German University in Cairo	Phase 2
Cairo University	Phase 2
University of Houston	N/A

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
Cadila Pharms Ltd	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	211324-001	Aug 18, 2020	AB	RX	No	No
Watson Labs Inc	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	200825-001	Jan 21, 2015	AB	RX	No	No
Invagen Pharms	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	090842-001	Sep 24, 2014	AB	RX	No	No
Amneal Pharms	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	208206-001	Apr 8, 2016	AB	RX	No	No
Aurobindo Pharma	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	204310-001	Aug 28, 2015	AB	RX	No	No
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997	AB	RX	Yes	Yes
Sciegen Pharms Inc	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	206384-001	Oct 12, 2016	AB	RX	No	No

Expired US Patents for raloxifene hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997