Astrazeneca Ab Company Profile

What is the competitive landscape for ASTRAZENECA AB, and when can generic versions of ASTRAZENECA AB drugs launch?

ASTRAZENECA AB has twelve approved drugs.

There are fifty-four US patents protecting ASTRAZENECA AB drugs. There is one tentative approval on ASTRAZENECA AB drugs.

There are nine hundred and twelve patent family members on ASTRAZENECA AB drugs in fifty-four countries and one hundred and forty-two supplementary protection certificates in nineteen countries.

Summary for Astrazeneca Ab

International Patents:	912
US Patents:	54
Tradenames:	13
Ingredients:	10
NDAs:	12
Drug Master File Entries:	2
Patent Litigation for Astrazeneca Ab:	See patent lawsuits for Astrazeneca Ab
PTAB Cases with Astrazeneca Ab as patent owner:	See PTAB cases with Astrazeneca Ab as patent owner

Drugs and US Patents for Astrazeneca Ab

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
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes	8,221,786*PED				Y
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	11,833,292		Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017		RX	Yes	No	8,501,698*PED				Y
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	11,331,442		Y
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	9,463,161		Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes	9,181,549			Y

Expired US Patents for Astrazeneca Ab

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	6,956,026
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019	RE44186
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	7,741,269
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	6,824,822
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019	9,198,925
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	6,479,065
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-003	Sep 25, 2007	6,114,304

Paragraph IV (Patent) Challenges for ASTRAZENECA AB drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	2.5 mg and 5 mg		2013-07-31
	Injection	250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe		2014-06-11
	HydrochlorideExtended-release Tablets	2.5 mg/1000 mg		2018-10-29
	Extended-release Tablets	5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg		2013-07-31

International Patents for Astrazeneca Ab Drugs

Country	Patent Number	Estimated Expiration
Hungary	230727
Ukraine	88168
Brazil	0014722
Japan	5030292
Australia	2011200663
South Korea	102428545
Spain	2809178

Supplementary Protection Certificates for Astrazeneca Ab Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498758	C20200010 00328	Estonia		PRODUCT NAME: METFORMIIN/SAKSAGLIPTIIN/DAPAGLIFLOSIIN;REG NO/DATE: EU/1/19/1401 13.11.2019
1412357	C300357	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2139494	PA2020522	Lithuania		PRODUCT NAME: SASAGLIPTINAS IR DAPAGLIFLOZINAS; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357	SPC/GB08/040	United Kingdom		PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
1734971	PA2012006	Lithuania		PRODUCT NAME: EXENATIDUM; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110617
1412357	77 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408

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