ASTRAZENECA Company Profile

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

ASTRAZENECA has ninety-one approved drugs.

There are one hundred and eighteen US patents protecting ASTRAZENECA drugs. There is one tentative approval on ASTRAZENECA drugs.

There are two thousand one hundred and thirty patent family members on ASTRAZENECA drugs in sixty-eight countries and three hundred and thirty-one supplementary protection certificates in twenty countries.

Summary for ASTRAZENECA

International Patents:	2130
US Patents:	118
Tradenames:	65
Ingredients:	57
NDAs:	91
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	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	8,815,258
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	AB	RX	Yes	No
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,216,180*PED				Y
Astrazeneca	ISOETHARINE HYDROCHLORIDE	isoetharine hydrochloride	SOLUTION;INHALATION	089618-001	Jun 13, 1991		DISCN	No	No
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989		DISCN	Yes	No
Astrazeneca	LEXXEL	enalapril maleate; felodipine	TABLET, EXTENDED RELEASE;ORAL	020668-002	Oct 28, 1998		DISCN	No	No

Expired US Patents for ASTRAZENECA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	5,424,286
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	6,479,065
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005	5,424,286
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-004	Dec 15, 2011	6,428,810*PED
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	6,858,576
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998	4,636,499*PED
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	6,414,126

Paragraph IV (Patent) Challenges for ASTRAZENECA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	50 mg		2008-10-17
	Tablets	60 mg		2015-09-30
	Delayed-release	20 mg and 40 mg		2005-08-05
	Tablets	25 mg		2005-08-12
	Injection	50 mg/mL, 2.5 mL and 5 mL syringe		2009-10-01
	Tablets	100 mg, 200 mg and 300 mg		2006-02-21
	Nasal Spray	5 mg/spray		2013-11-14
	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
	Nasal Spray	0.032 mg (32 mcg)/spray		2007-05-14
	Tablets	500 mcg		2015-03-02
	Delayed-release for Oral Suspension	2.5 mg and 5 mg		2018-09-24
	Tablets	50 mg, 150 mg and 400 mg		2007-02-12
	For Injection	20 mg/vial and 40 mg/vial		2009-11-23
	Injection	250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe		2014-06-11
	Nasal Spray	2.5 mg/spray		2016-06-09
	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

International Patents for ASTRAZENECA Drugs

Country	Patent Number	Estimated Expiration
Canada	2716724
Australia	2004294790
Japan	2014111636
Mexico	2011012685
Japan	2017105706
Estonia	04915
Israel	180099

Supplementary Protection Certificates for ASTRAZENECA Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0007293	95C0001	Belgium		PRODUCT NAME: FELODIPINE, METOPOLOL SUCCINATE; NAT. REGISTRATION NO/DATE: 122 IS 160 F 3 / 19921230; FIRST REGISTRATION: DK 8678 19921230
2435025	PA2019014,C2435025	Lithuania		PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1200431	PA2013001,C1200431	Lithuania		PRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720
2563920	CA 2019 00001	Denmark		PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710
1606261	C20100008 00033	Estonia		PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
2435025	PA2019014	Lithuania		PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218

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