Azurity Company Profile

What is the competitive landscape for AZURITY

AZURITY has fifty-nine approved drugs.

There are one hundred and sixty-seven US patents protecting AZURITY drugs. There are two tentative approvals on AZURITY drugs.

Summary for Azurity

US Patents:	167
Tradenames:	62
Ingredients:	53
NDAs:	59
Patent Litigation for Azurity:	See patent lawsuits for Azurity
PTAB Cases with Azurity as petitioner:	See PTAB cases with Azurity as petitioner

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	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes	11,771,686
Azurity	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	9,649,456		Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	11,771,733		Y
Azurity	ERYTHROCIN STEARATE	erythromycin stearate	TABLET;ORAL	060359-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Azurity	PREVDUO	glycopyrrolate; neostigmine methylsulfate	SOLUTION;INTRAVENOUS	216903-001	Feb 23, 2023		DISCN	Yes	No	12,151,020		Y
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423-003	Jun 5, 2025		DISCN	Yes	No

Expired US Patents for Azurity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	10,588,895
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	10,034,867
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011	8,114,909
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	5,583,141
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	5,958,961
Azurity	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	8,591,864

Paragraph IV (Patent) Challenges for AZURITY drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	8.5 mg and 17 mg		2009-03-02
	Extended-release Tablets	100 mg and 200 mg		2006-07-20
	Powder for Oral Solution	1 mg/mL		2016-06-21
	Oral Solution	1 mg/mL		2018-08-31
	Nasal Spray	250 mcg		2012-02-13
	Extended-release Tablets	20 mg and 30 mg		2007-11-07
	Extended-release Tablets	40 mg		2007-06-11
	Extended-release Tablets	300 mg		2006-05-19
	Injection	30 mg/mL, 17 mL single-use vials		2015-12-04
	Oral Solution	17.5 g/3.13 g/1.6 g per bottle		2010-11-08
	Extended-release Tablets	8 mg/90 mg		2015-03-12
	Extended-release Tablets	25.5 mg and 34 mg		2008-11-28

International Patents for Azurity Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	2061448
Japan	2023063282
New Zealand	545989
San Marino	T202500290
Peru	20190406
Japan	5856095

Supplementary Protection Certificates for Azurity Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	C201730057	Spain		PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
1411900	1190013-1	Sweden		PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	300918	Netherlands		PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0734381	SPC/GB04/011	United Kingdom		PRODUCT NAME: APREPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/03/262/001 20031113; UK EU/1/03/262/002 20031113; UK EU/1/03/262/003 20031113; UK EU/1/03/262/004 20031113; UK EU/1/03/262/005 20031113; UK EU/1/03/262/006 20031113

Similar Applicant Names

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

• Azurity