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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-eight US patents protecting ASTRAZENECA drugs.

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

Summary for ASTRAZENECA

International Patents:	2767
US Patents:	148
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	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		RX	Yes	Yes	9,198,925
Astrazeneca	XYLOCAINE	lidocaine	OINTMENT;TOPICAL	008048-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca Pharms	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	8,802,152			Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No	6,515,117		Y	Y
Astrazeneca	DALGAN	dezocine	INJECTABLE;INJECTION	019082-001	Dec 29, 1989		DISCN	No	No
Astrazeneca Ab	BYDUREON BCISE	exenatide	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	6,824,822		Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		RX	Yes	Yes	8,758,292		Y

Expired US Patents for ASTRAZENECA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-001	Approved Prior to Jan 1, 1982	4,536,516*PED
Astrazeneca Pharms	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-007	Oct 4, 2005	4,879,288*PED
Astrazeneca	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006	7,143,764
Astrazeneca	LEXXEL	enalapril maleate; felodipine	TABLET, EXTENDED RELEASE;ORAL	020668-002	Oct 28, 1998	4,374,829
Astrazeneca Pharms	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-002	Feb 20, 2001	5,599,794
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	7,741,269
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	7,297,761

Paragraph IV (Patent) Challenges for ASTRAZENECA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for ASTRAZENECA Drugs

Country	Document Number	Estimated Expiration
Peru	24592014
European Patent Office	1506211
Denmark	2409707
South Korea	20140011425
Argentina	095600
Spain	2234681
Portugal	1227817

Supplementary Protection Certificates for ASTRAZENECA Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
017	Luxembourg		92017, EXPIRES: 20230525
2009009	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
2013008	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
15/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
13/013	Ireland		PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
2010010	Lithuania		PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
2009009,C0823900	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624

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