DrugPatentWatch Database Preview

ASTRAZENECA Company Profile

« Back to Dashboard

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 forty US patents protecting ASTRAZENECA drugs.

There are two thousand five hundred and twenty-six patent family members on ASTRAZENECA drugs in seventy-two countries and two hundred and twenty-two supplementary protection certificates in sixteen countries.

Summary for ASTRAZENECA

International Patents:	2526
US Patents:	140
Tradenames:	66
Ingredients:	56
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 Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes	6,515,117		Y	Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		RX	Yes	Yes	8,758,292		Y
Astrazeneca Pharms	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No	9,050,309			Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017		RX	Yes	Yes	8,716,251		Y

Expired US Patents for ASTRAZENECA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Pharms	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	5,629,305*PED
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-002	May 17, 2007	4,879,288*PED
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005	6,858,576
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-002	Mar 21, 1994	4,536,516*PED
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	6,956,026
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-003	Sep 25, 2007	5,998,367

Paragraph IV (Patent) Challenges for ASTRAZENECA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Inhalation Suspension	0.25 mg/2 mL and 0.5 mg/2 mL		2005-09-15
	Injection	50 mg/mL, 2.5 mL and 5 mL syringe		2009-10-01
	Delayed-release Capsules	20 mg		2007-03-19
	Nasal Spray	2.5 mg/spray		2016-06-09
	Tablets	90 mg		2015-07-20
	Extended-release Tablets	150 mg		2008-11-17
	Tablets	500 mcg		2015-03-02
	Extended-release Tablets	50 mg		2008-10-17
	Tablets	25 mg		2005-08-12
	Extended-release Tablets	5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg		2013-07-31
	Tablets	100 mg, 200 mg and 300 mg		2006-02-21
	Tablets	2.5 mg and 5 mg		2013-07-31
	Delayed-release for Oral Suspension	2.5 mg and 5 mg		2018-09-24
	Nasal Spray	250 mcg		2012-02-13
	Nasal Spray	0.032 mg (32 mcg)/spray		2007-05-14
	Inhalation Suspension	1 mg/2 mL		2010-05-28
	Nasal Spray	5 mg/spray		2013-11-14
	Delayed-release Tablets	20 mg		2012-03-30
	Extended-release Tablets	400 mg		2008-06-18
	Tablets	60 mg		2015-09-30
	Tablets	200 mg and 300 mg		2008-06-12
	Tablets	12.5 mg and 25 mg		2018-09-17
	Injection	250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe		2014-06-11
	Tablets	50 mg, 150 mg and 400 mg		2007-02-12
	HydrochlorideExtended-release Tablets	2.5 mg/1000 mg		2018-10-29
	Delayed-release	20 mg and 40 mg		2005-08-05
	For Injection	20 mg/vial and 40 mg/vial		2009-11-23

International Patents for ASTRAZENECA Drugs

Country	Patent Number	Estimated Expiration
Australia	2001295789
South Korea	20060126714
Australia	687087
Poland	323362
Spain	2266322
Egypt	25854

Supplementary Protection Certificates for ASTRAZENECA Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	17C1031	France		PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
0823900	PA2009009	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
1261586	C300524	Netherlands		PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
0480717	SPC/GB98/025	United Kingdom		PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
0706513	34/2010	Austria		PRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705
1633724	C300726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216

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
• Astrazeneca Pharms