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BOEHRINGER INGELHEIM Company Profile

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What is the competitive landscape for BOEHRINGER INGELHEIM, and what generic alternatives to BOEHRINGER INGELHEIM drugs are available?

BOEHRINGER INGELHEIM has forty-nine approved drugs.

There are ninety US patents protecting BOEHRINGER INGELHEIM drugs. There is one tentative approval on BOEHRINGER INGELHEIM drugs.

There are two thousand two hundred and eighty-four patent family members on BOEHRINGER INGELHEIM drugs in sixty-seven countries and one hundred and sixty-seven supplementary protection certificates in fifteen countries.

Summary for BOEHRINGER INGELHEIM

International Patents:	2284
US Patents:	90
Tradenames:	40
Ingredients:	30
NDAs:	49
Patent Litigation for BOEHRINGER INGELHEIM:	See patent lawsuits for BOEHRINGER INGELHEIM
PTAB Cases with BOEHRINGER INGELHEIM as petitioner:	See PTAB cases with BOEHRINGER INGELHEIM as petitioner

Drugs and US Patents for BOEHRINGER INGELHEIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-005	Feb 19, 2010	AB	RX	Yes	No	8,679,533		Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-002	Feb 19, 2010	AB	RX	Yes	No	7,695,734		Y
Boehringer Ingelheim	AGGRENOX	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	020884-001	Nov 22, 1999	AB	RX	Yes	Yes
Boehringer Ingelheim	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	AB	RX	Yes	Yes

Expired US Patents for BOEHRINGER INGELHEIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	CATAPRES	clonidine hydrochloride	TABLET;ORAL	017407-001	Approved Prior to Jan 1, 1982	3,454,701
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004	5,683,677
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014	6,726,124*PED
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-002	Oct 16, 2009	5,591,762

Paragraph IV (Patent) Challenges for BOEHRINGER INGELHEIM drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	eq. to 110 mg base		2015-12-15
	Extended-release Capsules	25 mg and 200 mg		2007-02-01
	Extended-releaseTablets	2.5 mg/1000 mg 5 mg/1000 mg		2018-03-28
	Tablets	0.25 mg		2005-05-27
	Capsules	0.4 mg		2004-12-20
	Tablets	80 mg/12.5 mg and 40 mg/12.5 mg		2008-12-31
	Oral Suspension	7.5 mg/5 mL		2009-12-17
	Extended-release Tablets	2.25 mg and 3.75 mg		2011-07-26
	Capsules	eq. to 75 mg base and 150 mg base		2014-10-20
	Tablets	2.5 mg/500 mg, 2.5 mg/850 mg, 2.5 mg/1000 mg		2015-05-04
	Tablets	20 mg, 30 mg and 40 mg		2017-07-12
	Tablets	0.125 mg, 0.5 mg, 1 mg and 1.5 mg		2005-06-24
	Tablets	0.75 mg		2008-07-31
	Tablets	20 mg, 40 mg and 80 mg		2006-12-26
	Tablets	80 mg/25 mg		2009-02-27
	Extended-release Tablets	0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg		2010-06-01
	Extended-release Tablets	400 mg		2013-06-21
	Tablets	5 mg		2015-05-04

Non-Orange Book US Patents for BOEHRINGER INGELHEIM

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
6,710,055	Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions
8,486,398	Anticoagulant antidotes comprising antibodies that bind dabigatran and/or related compounds
8,404,697	Quinazoline derivatives for the treatment of cancer diseases
9,044,424	Methods of regulating glucose metabolism, and reagents related thereto

International Patents for BOEHRINGER INGELHEIM Drugs

Country	Document Number	Estimated Expiration
South Africa	200406750
Japan	2010159305
Spain	2298851
Germany	602005009745

Supplementary Protection Certificates for BOEHRINGER INGELHEIM Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90016-1	Sweden		PRODUCT NAME: OLODATEROL, INDIVIDUELLA OPTISKA ISOMERER DAERAV, BLANDNINGAR AV DE SEPARATA ENANTIOMERERNA ELLER RACEMATEN DAERAV, SYRA ADDITIONSSALTER DAERAV MED FARMAKOLOGISKT GODTAGBARA SYROR SAVAEL SOM SOLVATER OCH/ELLER HYDRATER DAERAV, SAERSKILT OLODATEROL OCH OLODATEROLHYDROKLORID; NAT. REG. NO/DATE: MT-NR 48116 20131114; FIRST REG.: MT MA 211/00401 20130918
07C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
437	Luxembourg		91437, EXPIRES: 20230216
2013	Austria		PRODUCT NAME: DIBIGATRANEXILAT (MESYLAT); REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318

Similar Applicant Names

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

• Boehringer Ingelheim