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NUEDEXTA Drug Profile

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

Nuedexta is a drug marketed by Avanir Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-four patent family members in twenty-one countries.

The generic ingredient in NUEDEXTA is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.

Summary for NUEDEXTA

International Patents:	64
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	8
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	NUEDEXTA at DailyMed

Pharmacology for NUEDEXTA

Drug Class	Uncompetitive N-methyl-D-aspartate Receptor Antagonist Sigma-1 Agonist Antiarrhythmic Cytochrome P450 2D6 Inhibitor
Mechanism of Action	Uncompetitive NMDA Receptor Antagonists Sigma-1 Receptor Agonists Cytochrome P450 2D6 Inhibitors

US Patents and Regulatory Information for NUEDEXTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	AB	RX	Yes	Yes
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	AB	RX	Yes	Yes

Expired US Patents for NUEDEXTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010

Paragraph IV (Patent) Challenges for NUEDEXTA

Drugname	Dosage	Strength	RLD	Submissiondate
	Capsules	20 mg/10 mg		2011-03-07

International Patents for NUEDEXTA

Country	Document Number	Estimated Expiration
Israel	211593
Portugal	1980252
European Patent Office	2322179
Japan	2014058575

Supplementary Protection Certificates for NUEDEXTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1	Finland
2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
0130030 00105	Estonia		PRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013
/2013	Austria		PRODUCT NAME: KOMBINATION VON A) DEXTROMETHORPHAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE DEXTROMETHORPHANHYDROBROMID, UND INSBESONDERE DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT UND B) CHINIDIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE CHINIDINSULFAT, UND INSBESONDERE CHINIDINSULFATDIHYDRAT.; REGISTRATION NO/DATE: EU/1/13/833 20130626