AZURITY Company Profile

What is the competitive landscape for AZURITY, and when can generic versions of AZURITY drugs launch?

AZURITY has twenty-three approved drugs.

There are seventy-eight US patents protecting AZURITY drugs.

There are three hundred and thirty-five patent family members on AZURITY drugs in forty-eight countries and forty-one supplementary protection certificates in fifteen countries.

Summary for AZURITY

International Patents:	335
US Patents:	78
Tradenames:	23
Ingredients:	22
NDAs:	23
Patent Litigation for AZURITY:	See patent lawsuits for AZURITY

Drugs and US Patents for AZURITY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	E.E.S.	erythromycin ethylsuccinate	GRANULE;ORAL	050207-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Azurity	ZONISADE	zonisamide	SUSPENSION;ORAL	214273-001	Jul 15, 2022		RX	Yes	Yes	11,478,456
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes	8,026,279		Y	Y
Azurity	PREVDUO	glycopyrrolate; neostigmine methylsulfate	SOLUTION;INTRAVENOUS	216903-001	Feb 23, 2023		RX	Yes	Yes	11,110,054		Y
Azurity	EPRONTIA	topiramate	SOLUTION;ORAL	214679-001	Nov 5, 2021		RX	Yes	Yes	11,633,374		Y
Azurity	PCE	erythromycin	TABLET, COATED PARTICLES;ORAL	050611-001	Sep 9, 1986		DISCN	Yes	No

Expired US Patents for AZURITY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	6,465,463
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996	5,179,189
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	5,958,961
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	5,958,961
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996	4,757,128
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	5,736,555

Paragraph IV (Patent) Challenges for AZURITY drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Oral Solution	1 mg/mL		2018-08-31

International Patents for AZURITY Drugs

Country	Patent Number	Estimated Expiration
China	106573037
China	109922801
Taiwan	200902089
Slovenia	1677767
European Patent Office	3509592
Taiwan	200630086

Supplementary Protection Certificates for AZURITY Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
2317997	2190050-1	Sweden		PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
1003503	05C0048	France		PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Azurity