Azurity Company Profile

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

AZURITY has thirty-two approved drugs.

There are eighty-six US patents protecting AZURITY drugs.

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

Summary for Azurity

International Patents:	340
US Patents:	86
Tradenames:	31
Ingredients:	24
NDAs:	32
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	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-002	Jan 26, 2018	AB	RX	Yes	Yes	11,638,692		Y
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	11,116,724
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016	AB	RX	Yes	Yes	10,772,868		Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	10,894,039
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No	7,572,920		Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019		RX	Yes	No	11,896,562

Expired US Patents for Azurity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	5,583,141
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	5,958,961
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-004	Jan 30, 2019	10,130,580
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	5,583,141
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996	5,179,189
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996	4,757,128

Paragraph IV (Patent) Challenges for AZURITY drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Oral Solution	1 mg/mL		2018-08-31
	Powder for Oral Solution	1 mg/mL		2016-06-21

International Patents for Azurity Drugs

Country	Patent Number	Estimated Expiration
New Zealand	579515
Portugal	1677767
Norway	338275
Portugal	2310385
Japan	2007508396
World Intellectual Property Organization (WIPO)	2004052844

Supplementary Protection Certificates for Azurity Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
0503785	C300375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
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	C20120005 00053	Estonia		PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
1718641	121 5004-2012	Slovakia		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207

Similar Applicant Names

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

• Azurity