ASTRAZENECA Company Profile

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

ASTRAZENECA has ninety-three approved drugs.

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

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

Summary for ASTRAZENECA

International Patents:	2203
US Patents:	125
Tradenames:	66
Ingredients:	60
NDAs:	93
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 BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	8,906,851*PED				Y
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015		RX	Yes	No
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No	8,383,678		Y
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023		RX	Yes	Yes	10,059,714		Y	Y
Astrazeneca	YUTOPAR	ritodrine hydrochloride	TABLET;ORAL	018555-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	6,515,117		Y	Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,216,180*PED				Y

Expired US Patents for ASTRAZENECA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-003	Aug 8, 2000	4,787,536*PED
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	8,431,154
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014	6,936,590
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997	4,668,218*PED
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-005	Aug 11, 2008	5,948,437*PED
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	6,872,700
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009	6,395,767

Paragraph IV (Patent) Challenges for ASTRAZENECA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for ASTRAZENECA Drugs

Country	Patent Number	Estimated Expiration
Singapore	10201801507R
Germany	60330227
Japan	2016041713
Taiwan	201204414
China	105056211
Hong Kong	1156844
European Patent Office	2144649

Supplementary Protection Certificates for ASTRAZENECA Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2673237	CA 2019 00014	Denmark		PRODUCT NAME: NATRIUMZIRCONIUMCYCLOSILICAT; REG. NO/DATE: EU/1/17/1173 20180326
1685839	92292	Luxembourg		PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
1856135	2090014-8	Sweden		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
2203431	CR 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
1482932	334 8-2019	Slovakia		PRODUCT NAME: BINIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1315 20180924
2435024	PA2021511,C2435024	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209
2734522	122021000020	Germany		PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1479 20201105

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