ASTRAZENECA Company Profile

What is the competitive landscape for ASTRAZENECA, and what generic alternatives to ASTRAZENECA drugs are available?

ASTRAZENECA has ninety-two approved drugs.

There are one hundred and twenty-six US patents protecting ASTRAZENECA drugs. There is one tentative approval on ASTRAZENECA drugs.

There are two thousand two hundred and fourteen patent family members on ASTRAZENECA drugs in seventy countries and three hundred and forty-eight supplementary protection certificates in twenty countries.

Summary for ASTRAZENECA

International Patents:	2214
US Patents:	126
Tradenames:	65
Ingredients:	60
NDAs:	92
Patent Litigation for ASTRAZENECA:	See patent lawsuits for ASTRAZENECA
PTAB Cases with ASTRAZENECA as patent owner:	See PTAB cases with ASTRAZENECA as patent owner

Drugs and US Patents for ASTRAZENECA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No	11,975,001		Y
Astrazeneca	DALGAN	dezocine	INJECTABLE;INJECTION	019082-001	Dec 29, 1989		DISCN	No	No
Astrazeneca	XYLOCAINE 5% W/ GLUCOSE 7.5%	lidocaine hydrochloride	INJECTABLE;SPINAL	010496-002	Jul 7, 1982		DISCN	No	No
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes	7,456,254*PED				Y
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003		DISCN	No	No
Astrazeneca	SORBITRATE	isosorbide dinitrate	TABLET, CHEWABLE;ORAL	016776-003	Apr 1, 1996		DISCN	No	No

Expired US Patents for ASTRAZENECA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	7,265,124
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001	6,191,148*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	5,972,919
Astrazeneca	LEXXEL	enalapril maleate; felodipine	TABLET, EXTENDED RELEASE;ORAL	020668-001	Dec 27, 1996	4,803,081*PED
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-002	Oct 20, 2006	4,738,974*PED
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	6,479,065

Paragraph IV (Patent) Challenges for ASTRAZENECA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	60 mg		2015-09-30
	Tablets	25 mg		2005-08-12
	Delayed-release	20 mg and 40 mg		2005-08-05
	Tablets	100 mg, 200 mg and 300 mg		2006-02-21
	For Injection	20 mg/vial and 40 mg/vial		2009-11-23
	Extended-release Tablets	5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg		2013-07-31
	Inhalation Suspension	0.25 mg/2 mL and 0.5 mg/2 mL		2005-09-15
	Tablets	2.5 mg and 5 mg		2013-07-31
	Delayed-release Capsules	20 mg		2007-03-19
	Extended-release Tablets	400 mg		2008-06-18
	Tablets	200 mg and 300 mg		2008-06-12
	Tablets	90 mg		2015-07-20
	Tablets	500 mcg		2015-03-02
	Nasal Spray	0.032 mg (32 mcg)/spray		2007-05-14
	Tablets	50 mg, 150 mg and 400 mg		2007-02-12
	Delayed-release for Oral Suspension	2.5 mg and 5 mg		2018-09-24
	Injection	250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe		2014-06-11
	Injection	50 mg/mL, 2.5 mL and 5 mL syringe		2009-10-01
	HydrochlorideExtended-release Tablets	2.5 mg/1000 mg		2018-10-29
	Inhalation Suspension	1 mg/2 mL		2010-05-28
	Delayed-release Tablets	20 mg		2012-03-30
	Extended-release Tablets	150 mg		2008-11-17
	Extended-release Tablets	50 mg		2008-10-17

International Patents for ASTRAZENECA Drugs

Country	Patent Number	Estimated Expiration
Saudi Arabia	109300599
Taiwan	200613019
Australia	2004282219
Hungary	S2100018
Austria	418547
Luxembourg	91989

Supplementary Protection Certificates for ASTRAZENECA Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1968948	122021000074	Germany		PRODUCT NAME: SELUMETINIB (EINSCHLIESSLICH PHARMAZEUTISCH AKZEPTABLER SALZE (INSBESONDERE HYDROGENSULFAT), ESTER, SOLVATE ODER ENANTIOMERE DAVON); REGISTRATION NO/DATE: EU/1/21/1552 20210617
1412357	50/2008	Austria		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
1140145	SZ 30/2007	Austria		PRODUCT NAME: EXENATIDE
1856135	LUC00153	Luxembourg		PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
2435024	PA2021511	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209
2346495	PA2018014	Lithuania		PRODUCT NAME: AMORFINIS OLAPARIBAS ARBA JO DRUSKA ARBA SOLVATAS KIETOJE DISPERSIJOJE; REGISTRATION NO/DATE: EU/1/14/959 20180508

Similar Applicant Names

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

• Astral
• Astrazeneca
• Astrazeneca Ab
• Astrazeneca Lp