EDLUAR Drug Patent Profile

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

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

The generic ingredient in EDLUAR is zolpidem tartrate. There is one drug master file entry for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Edluar

A generic version of EDLUAR was approved as zolpidem tartrate by PHARMAZONE on April 23^rd, 2007.

Summary for EDLUAR

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Patent Applications:	124
Drug Prices:	Drug price information for EDLUAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDLUAR
What excipients (inactive ingredients) are in EDLUAR?	EDLUAR excipients list
DailyMed Link:	EDLUAR at DailyMed

See drug prices for EDLUAR

Pharmacology for EDLUAR

Drug Class	gamma-Aminobutyric Acid A Receptor Positive Modulator
Mechanism of Action	GABA A Receptor Positive Modulators
Physiological Effect	Central Nervous System Depression

Paragraph IV (Patent) Challenges for EDLUAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EDLUAR	Sublingual Tablets	zolpidem tartrate	5 mg and 10 mg	021997	1	2010-04-29

US Patents and Regulatory Information for EDLUAR

EDLUAR is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	AB	RX	Yes	No	9,265,720
Viatris	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009	AB	RX	Yes	Yes	9,597,281
Viatris	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	AB	RX	Yes	No	9,597,281
Viatris	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009	AB	RX	Yes	Yes	9,265,720

Expired US Patents for EDLUAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	6,761,910
Viatris	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009	6,761,910
Viatris	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009	8,512,747
Viatris	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	8,512,747

International Patents for EDLUAR

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

Country	Patent Number	Title	Estimated Expiration
Austria	365540
Australia	6492799
Australia	764346
Bulgaria	105379
Bulgaria	65502

Supplementary Protection Certificates for EDLUAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132	CA 2015 00004	Denmark		PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2236132	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132	484	Finland