Toremifene citrate - Generic Drug Details

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What are the generic drug sources for toremifene citrate and what is the scope of freedom to operate?

Toremifene citrate is the generic ingredient in two branded drugs marketed by Kyowa Kirin, MSN, and Rising, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for toremifene citrate. Four suppliers are listed for this compound.

Summary for toremifene citrate

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	6
Patent Applications:	8,472
What excipients (inactive ingredients) are in toremifene citrate?	toremifene citrate excipients list
DailyMed Link:	toremifene citrate at DailyMed

Recent Clinical Trials for toremifene citrate

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

Sponsor	Phase
Fred Hutchinson Cancer Research Center	Phase 4
National Cancer Institute (NCI)	Phase 4
Federal University of São Paulo	Phase 4

See all toremifene citrate clinical trials

Pharmacology for toremifene citrate

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

Medical Subject Heading (MeSH) Categories for toremifene citrate

Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for toremifene citrate

L02BA	Anti-estrogens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for toremifene citrate

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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
Msn	TOREMIFENE CITRATE	toremifene citrate	TABLET;ORAL	212818-001	Aug 18, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	TOREMIFENE CITRATE	toremifene citrate	TABLET;ORAL	208813-001	Dec 4, 2018	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Kyowa Kirin	FARESTON	toremifene citrate	TABLET;ORAL	020497-001	May 29, 1997		DISCN	Yes	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 toremifene citrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kyowa Kirin	FARESTON	toremifene citrate	TABLET;ORAL	020497-001	May 29, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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