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Astrazeneca Pharms Company Profile

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

ASTRAZENECA PHARMS has twenty-three approved drugs.

There are seventy-five US patents protecting ASTRAZENECA PHARMS drugs.

Summary for Astrazeneca Pharms

US Patents:	75
Tradenames:	20
Ingredients:	17
NDAs:	23

Drugs and US Patents for Astrazeneca Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Pharms	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No	7,662,365		Y	Y
Astrazeneca Pharms	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes	9,732,058		Y	Y
Astrazeneca Pharms	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes	7,151,102		Y	Y
Astrazeneca Pharms	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes
Astrazeneca Pharms	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	9,861,658
Astrazeneca Pharms	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes	6,681,768		Y

Expired US Patents for Astrazeneca Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Pharms	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	4,636,499*PED
Astrazeneca Pharms	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998	5,093,342*PED
Astrazeneca Pharms	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998	5,629,305*PED
Astrazeneca Pharms	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-003	Sep 26, 1997	4,879,288*PED
Astrazeneca Pharms	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001	5,093,342
Astrazeneca Pharms	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015	5,770,599

Paragraph IV (Patent) Challenges for ASTRAZENECA PHARMS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	25 mg		2005-08-12
	Tablets	100 mg, 200 mg and 300 mg		2006-02-21
	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
	Tablets	90 mg		2015-07-20
	Tablets	500 mcg		2015-03-02
	Tablets	50 mg, 150 mg and 400 mg		2007-02-12
	Delayed-release	20 mg and 40 mg		2005-08-05
	Nasal Spray	250 mcg		2012-02-13
	Inhalation Suspension	1 mg/2 mL		2010-05-28
	Delayed-release Tablets	20 mg		2012-03-30
	Tablets	60 mg		2015-09-30

Non-Orange Book US Patents for Astrazeneca Pharms

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
7,109,210	Quinuclidine derivatives and medicinal compositions containing the same
8,513,279	Quinuclidine derivatives and medicinal compositions containing the same
7,196,098	Quinuclidine derivatives and medicinal compositions containing the same
9,566,276	Phthalazinone derivatives
7,897,617	Quinuclidine derivatives and medicinal compositions containing the same
9,662,352	Microporous zirconium silicate for the treatment of hyperkalemia

International Patents for Astrazeneca Pharms Drugs

Country	Document Number	Estimated Expiration
Israel	155645
Cyprus	1114210
Ecuador	SP13012531
Russian Federation	2580315
South Korea	20120015334
Denmark	1386917

Supplementary Protection Certificates for Astrazeneca Pharms Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
15/024	Ireland		PRODUCT NAME: NALOXEGOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE OXALATE SALT OF THE ALPHA-EPIMER OF NALOXEGOL; REGISTRATION NO/DATE: EU/1/14/962 20141208
2012000051	Germany		PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
3 50005-2015	Slovakia		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218
C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
99C0030	Belgium		PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508

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