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ASTRAZENECA Company Profile

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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-five US patents protecting ASTRAZENECA drugs.

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

Summary for ASTRAZENECA

International Patents:	2716
US Patents:	145
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 Pharms	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-004	Dec 15, 2011		RX	Yes	No	7,411,070*PED				Y
Astrazeneca	LEXXEL	enalapril maleate; felodipine	TABLET, EXTENDED RELEASE;ORAL	020668-002	Oct 28, 1998		DISCN	No	No
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005		RX	Yes	Yes	7,741,269
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017		RX	Yes	Yes	8,716,251		Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014		RX	Yes	No	6,515,117		Y	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	019810-003	Oct 5, 1995	4,636,499*PED
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014	5,877,192*PED
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	5,424,286
Astrazeneca	YUTOPAR	ritodrine hydrochloride	TABLET;ORAL	018555-001	Approved Prior to Jan 1, 1982	3,410,944
Astrazeneca Pharms	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998	4,853,230*PED
Astrazeneca Pharms	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001	5,900,424*PED
Astrazeneca Pharms	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	4,786,505*PED

Paragraph IV (Patent) Challenges for ASTRAZENECA drugs

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

Non-Orange Book US Patents for ASTRAZENECA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,389,472	Exendin-4 to treat nonalcoholic steatohepatitis and nonalcoholic fatty liver disease
2,015,197,470
5,424,394	Synthetic preparation of amylin and amylin analogues
8,802,699	Quinuclidine derivatives and medicinal compositions containing the same
7,521,423	Exendin pharmaceutical compositions
6,610,824	Amylin agonist peptides and uses therefor
7,109,210	Quinuclidine derivatives and medicinal compositions containing the same

International Patents for ASTRAZENECA Drugs

Country	Document Number	Estimated Expiration
Czech Republic	304689
Singapore	10201408404X
European Patent Office	2305221
World Intellectual Property Organization (WIPO)	03070279
Spain	2593582
Argentina	073792
Austria	299031

Supplementary Protection Certificates for ASTRAZENECA Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2011004,C1135391	Lithuania		PRODUCT NAME: TICAGRELORUM; REGISTRATION NO/DATE: EU/1/10/655/001 2010 12 03 EU/1/10/655/002 2010 12 03 EU/1/10/655/003 2010 12 03 EU/1/10/655/004 2010 12 03 EU/1/10/655/005 2010 12 03 EU/1/10/655/00 20101203
C0022	France		PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
C005/2010	Ireland		SPC005/2010: 20100702, EXPIRES: 20240930
2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
2011004	Lithuania		PRODUCT NAME: TICAGRELORUM; REGISTRATION NO/DATE: EU/1/10/655/001 2010 12 03 EU/1/10/655/002 2010 12 03 EU/1/10/655/003 2010 12 03 EU/1/10/655/004 2010 12 03 EU/1/10/655/005 2010 12 03 EU/1/10/655/00 20101203
2007 00033	Denmark		PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120

Similar Applicant Names

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

• Astrazeneca
• Astrazeneca Ab
• Astrazeneca Lp
• Astrazeneca Pharms