REMERON SOLTAB Drug Patent Profile

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When do Remeron Soltab patents expire, and when can generic versions of Remeron Soltab launch?

Remeron Soltab is a drug marketed by Organon Usa Organon and is included in one NDA.

The generic ingredient in REMERON SOLTAB is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Remeron Soltab

A generic version of REMERON SOLTAB was approved as mirtazapine by TEVA on January 24^th, 2003.

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Summary for REMERON SOLTAB

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	2
Patent Applications:	5,507
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for REMERON SOLTAB
DailyMed Link:	REMERON SOLTAB at DailyMed

Drug patent expirations by year for REMERON SOLTAB

Recent Clinical Trials for REMERON SOLTAB

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Sponsor	Phase
Teva Pharmaceuticals USA	Phase 1

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US Patents and Regulatory Information for REMERON SOLTAB

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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
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-002	Jan 12, 2001	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	AB	RX	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 REMERON SOLTAB

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	⤷ Sign Up	⤷ Sign Up
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	⤷ Sign Up	⤷ Sign Up
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001	⤷ Sign Up	⤷ Sign Up
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-002	Jan 12, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for REMERON SOLTAB

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dechra Regulatory B.V.	Mirataz	mirtazapine	EMEA/V/C/004733 For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions.	Authorised	no	no	no	2019-12-10
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for REMERON SOLTAB

See the table below for patents covering REMERON SOLTAB around the world.

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Country	Patent Number	Title	Estimated Expiration
Poland	320628		⤷ Sign Up
Australia	646232		⤷ Sign Up
European Patent Office	0813873	Compositions pharmaceutiques comprenants de la mirtazapine et un ou plusieurs inhibiteurs sélectifs d'assimilation de sérotonine (Pharmaceutical composition comprising mirtazapine and one or more selective serotonin reuptake inhibitors)	⤷ Sign Up
Argentina	007609	UNA COMPOSICION FARMACEUTICA	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for REMERON SOLTAB

Recent Clinical Trials for REMERON SOLTAB

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