Tamoxifen citrate - Generic Drug Details

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

Tamoxifen citrate is the generic ingredient in three branded drugs marketed by Mayne Pharma Commrcl, Astrazeneca, Actavis Labs Fl Inc, Aegis Pharms, Apotex, Dr Reddys Labs Sa, Eugia Pharma, Ivax Sub Teva Pharms, Mylan, Pharmachemie, Roxane, Teva, and Zydus Pharms, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for tamoxifen citrate. Fourteen suppliers are listed for this compound.

Summary for tamoxifen citrate

US Patents:	0
Tradenames:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	125
Patent Applications:	8,387
Drug Prices:	Drug price trends for tamoxifen citrate
What excipients (inactive ingredients) are in tamoxifen citrate?	tamoxifen citrate excipients list
DailyMed Link:	tamoxifen citrate at DailyMed

See drug prices for tamoxifen citrate

Drug Sales Revenue Trends for tamoxifen citrate

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Recent Clinical Trials for tamoxifen citrate

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

Sponsor	Phase
Sharif Medical Research Center	Phase 2
Baylor College of Medicine	Early Phase 1
Great Ormond Street Hospital Charity	Phase 1/Phase 2

See all tamoxifen citrate clinical trials

Pharmacology for tamoxifen citrate

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

Medical Subject Heading (MeSH) Categories for tamoxifen citrate

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

Anatomical Therapeutic Chemical (ATC) Classes for tamoxifen citrate

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

US Patents and Regulatory Information for tamoxifen 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
Eugia Pharma	TAMOXIFEN CITRATE	tamoxifen citrate	TABLET;ORAL	213358-001	Aug 14, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Sub Teva Pharms	TAMOXIFEN CITRATE	tamoxifen citrate	TABLET;ORAL	075740-001	Feb 20, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	TAMOXIFEN CITRATE	tamoxifen citrate	TABLET;ORAL	074504-001	Apr 28, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aegis Pharms	TAMOXIFEN CITRATE	tamoxifen citrate	TABLET;ORAL	076398-002	Mar 31, 2003		DISCN	No	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 tamoxifen citrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma Commrcl	SOLTAMOX	tamoxifen citrate	SOLUTION;ORAL	021807-001	Oct 29, 2005	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-002	Mar 21, 1994	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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