SOLTAMOX Drug Patent Profile

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

Soltamox is a drug marketed by Mayne Pharma Commrcl and is included in one NDA.

The generic ingredient in SOLTAMOX is tamoxifen citrate. There are sixteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Soltamox

A generic version of SOLTAMOX was approved as tamoxifen citrate by ACTAVIS LABS FL INC on February 20^th, 2003.

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Summary for SOLTAMOX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	21
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SOLTAMOX
What excipients (inactive ingredients) are in SOLTAMOX?	SOLTAMOX excipients list
DailyMed Link:	SOLTAMOX at DailyMed

Drug patent expirations by year for SOLTAMOX

Recent Clinical Trials for SOLTAMOX

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

Sponsor	Phase
Jose Pablo Leone	Phase 2
Translational Breast Cancer Research Consortium (TBCRC)	Phase 2
Eli Lilly and Company	Phase 2

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Pharmacology for SOLTAMOX

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

Anatomical Therapeutic Chemical (ATC) Classes for SOLTAMOX

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

US Patents and Regulatory Information for SOLTAMOX

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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
Mayne Pharma Commrcl	SOLTAMOX	tamoxifen citrate	SOLUTION;ORAL	021807-001	Oct 29, 2005		RX	Yes	Yes	⤷ 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

Expired US Patents for SOLTAMOX

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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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for SOLTAMOX

See the table below for patents covering SOLTAMOX around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	H1171269	ORAL LIQUID PHARMACEUTICAL PREPARATION	⤷ Try a Trial
Denmark	0893121		⤷ Try a Trial
European Patent Office	0893121	Solution liquide de médicament pour administration orale (Oral liquid medicine solution)	⤷ Try a Trial
Germany	69804169		⤷ Try a Trial
Portugal	893121		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for SOLTAMOX

Recent Clinical Trials for SOLTAMOX

Pharmacology for SOLTAMOX

Anatomical Therapeutic Chemical (ATC) Classes for SOLTAMOX

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