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	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-002	Jan 30, 2019		RX	Yes	No	10,130,580		Y
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020		RX	Yes	Yes	10,342,787		Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-005	Apr 16, 2021		DISCN	Yes	No	10,130,580		Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	10,695,329		Y
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No	8,026,279		Y	Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-002	Jan 30, 2019		RX	Yes	No	11,160,772		Y

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
Hungary	E040391
European Patent Office	2085087
Japan	2005272451
Denmark	1857457
World Intellectual Property Organization (WIPO)	2004052844
Russian Federation	2501798

Supplementary Protection Certificates for Azurity Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	436	Finland
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
1718641	1290016-3	Sweden		PRODUCT NAME: AZILSARTANMEDOXOMIL OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV, INKLUDERANDE KALIUMSALT; REG. NO/DATE: EU/1/11/735/001 20111207
1718641	C20120005 00053	Estonia		PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
1718641	91962	Luxembourg		91962, EXPIRES: 20261207
0260415	C990036	Netherlands		PRODUCT NAME: CARMUSTINE; NAT. REGISTRATION NO/DATE: RVG 24056 19990809; FIRST REGISTRATION: FR 561 907-5 19981210

Similar Applicant Names

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

• Azurity