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Abbvie Company Profile

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

ABBVIE has ninety approved drugs.

There are eighty-one US patents protecting ABBVIE drugs.

There are one thousand two hundred and eighty-four patent family members on ABBVIE drugs in sixty-six countries and one hundred and thirteen supplementary protection certificates in fourteen countries.

Summary for Abbvie

International Patents:	1284
US Patents:	81
Tradenames:	78
Ingredients:	65
NDAs:	90
Drug Master File Entries:	1
Patent Litigation for Abbvie:	See patent lawsuits for Abbvie

Drugs and US Patents for Abbvie

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000	AA	RX	Yes	Yes	8,501,219		Y
Abbvie	NORVIR	ritonavir	TABLET;ORAL	022417-001	Feb 10, 2010	AB	RX	Yes	Yes	8,691,878*PED				Y
Abbvie Inc	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No	8,546,399		Y	Y
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	8,648,037		Y	Y
Abbvie Inc	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		RX	Yes	Yes	8,686,026		Y
Abbvie Inc	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir	TABLET, TABLET;ORAL	206619-001	Dec 19, 2014		RX	Yes	Yes	8,492,386
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-001	Mar 10, 1983	AB	RX	Yes	No

Expired US Patents for Abbvie

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT-PED	leuprolide acetate	INJECTABLE;INJECTION	020263-003	Apr 16, 1993	5,330,767
Abbvie Endocrine Inc	LUPRON DEPOT-PED	leuprolide acetate	INJECTABLE;INJECTION	020263-008	Aug 15, 2011	6,036,976
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007	5,674,882*PED
Abbvie	KALETRA	lopinavir; ritonavir	CAPSULE;ORAL	021226-001	Sep 15, 2000	5,635,523*PED
Abbvie Endocrine Inc	LUPRON DEPOT-PED	leuprolide acetate	INJECTABLE;INJECTION	020263-006	Jan 21, 1994	5,330,767
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004	5,145,684
Abbvie Endocrine Inc	LUPRON DEPOT-PED	leuprolide acetate	INJECTABLE;INJECTION	020263-003	Apr 16, 1993	4,728,721

Paragraph IV (Patent) Challenges for ABBVIE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	250 mg		2004-05-03
	Delayed-release Capsules	45 mg		2009-09-02
	Extended-release Tablets	2 mg/180 mg and 2 mg/240 mg		2007-11-09
	Tablets	100 mg/25 mg		2008-12-23
	Extended-release Tablets	4 mg/ 240 mg		2007-07-24
	Tablets	100 mg		2010-12-21
	Tablets	400 mg and 600 mg		2010-05-10
	Injection	0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials		2008-11-28
	Tablets	145 mg		2007-10-19
	Capsules	4 mcg		2008-08-25
	Tablets	5 mg/200 mg		2005-05-27
	Gel	1.62%		2012-04-06
	Injection	2 mg/mL, 5 mL vial and 10 mg/mL, 20 mL vial		2009-08-04
	Extended-release Tablet	500 mg		2010-12-06
	Extended-release Tablets	500 mg		2005-02-08
	Delayed-release Capsules	135 mg		2009-09-01
	Extended-release Tablets	1 mg/240 mg		2008-02-20
	Oral Solution	80 mg/20 mg per mL		2014-06-19
	Tablets	1 mg, 2 mg and 4 mg		2004-10-04
	Capsules	100 mg		2012-10-31
	Tablets	48 mg		2008-07-01
	Capsules	1 mcg and 2 mcg		2008-10-14
	Tablets	2.5 mg/200 mg		2006-02-24
	Gel Metered-dose Pump	1%		2008-12-19
	Gel	1.62% (1.25 g and 2.5 g packets)		2013-06-19
	Injection	2 mg/mL, 10 mL vial		2009-08-12

Non-Orange Book US Patents for Abbvie

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
8,674,112	Polymorph of a pharmaceutical
8,236,352	Glipizide compositions
8,343,540	Process for producing fenofibrate tablets
9,616,135	2-iminobiotin formulations and uses thereof
9,713,595	Sustained-release composition and method for producing the same
7,183,416	Polymorph of a pharmaceutical
8,716,454	Solid compositions

International Patents for Abbvie Drugs

Country	Document Number	Estimated Expiration
Guatemala	201200314
Eurasian Patent Organization	201400115
Japan	2004238400
Japan	2011173927
Malaysia	146247
Spain	2475163
China	101797245

Supplementary Protection Certificates for Abbvie Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00115	Netherlands		PRODUCT NAME: EPROSARTANUM DESGEWENST IN DE VORM VAN EEN; NAT. REGISTRATION NO/DATE: RVG 25926 20020905; FIRST REGISTRATION: RVG 25926 20020905
C/GB12/028	United Kingdom		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
/2015	Austria		PRODUCT NAME: DASABUVIR ODER EIN SALZ DAVON, EINSCHLIESSLICH DASABUVIR-NATRIUM-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/14/983 20150115
2368890/01	Switzerland		PRODUCT NAME: OMBITASVIR; REGISTRATION NO/DATE: SWISSMEDIC 65301 25.11.2014
00006	Netherlands		PRODUCT NAME: EPROSARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MESYLAAT; NAT. REGISTRATION NO/DATE: RVG 22258 - RVG 22260 19980106; FIRST REGISTRATION: DE 39573.00.00 - 39573.00.00 19970417
2017033	Lithuania		PRODUCT NAME: PIBRENTASVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2015013	Lithuania		PRODUCT NAME: DASABUVIRUM; REGISTRATION NO/DATE: EU/1/14/983 20150115

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Abbvie
• Abbvie Endocrine
• Abbvie Endocrine Inc
• Abbvie Inc