Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
McKinsey
Moodys
Boehringer Ingelheim
Colorcon

Last Updated: November 13, 2019

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BOEHRINGER INGELHEIM Company Profile

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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 JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016 RX Yes No 9,415,016   Start Trial Y   Start Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes No 7,284,474*PED   Start Trial Y   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-001 Feb 19, 2010 AB RX Yes Yes 7,695,734   Start Trial Y   Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No 6,488,962   Start Trial Y   Start Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-002 Aug 1, 2014 RX Yes Yes 7,579,449   Start Trial Y   Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012 RX Yes No 8,846,695   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BOEHRINGER INGELHEIM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 6,453,795*PED   Start Trial
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 6,176,442   Start Trial
Boehringer Ingelheim VIRAMUNE nevirapine TABLET;ORAL 020636-001 Jun 21, 1996 5,366,972*PED   Start Trial
Boehringer Ingelheim CATAPRES-TTS-1 clonidine FILM, EXTENDED RELEASE;TRANSDERMAL 018891-001 Oct 10, 1984 4,060,084   Start Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 6,176,442   Start Trial
Boehringer Ingelheim MEXITIL mexiletine hydrochloride CAPSULE;ORAL 018873-002 Dec 30, 1985 4,031,244   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for BOEHRINGER INGELHEIM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-releaseTablets 2.5 mg/1000 mg 5 mg/1000 mg ➤ Subscribe 2018-03-28
➤ Subscribe Tablets 5 mg ➤ Subscribe 2015-05-04
➤ Subscribe Extended-release Tablets 2.25 mg and 3.75 mg ➤ Subscribe 2011-07-26
➤ Subscribe Extended-release Tablets 400 mg ➤ Subscribe 2013-06-21
➤ Subscribe Tablets 10 mg/5 mg and 25 mg/5 mg ➤ Subscribe 2018-08-01
➤ Subscribe Tablets 2.5 mg/500 mg, 2.5 mg/850 mg, 2.5 mg/1000 mg ➤ Subscribe 2015-05-04
➤ Subscribe Tablets 80 mg/12.5 mg and 40 mg/12.5 mg ➤ Subscribe 2008-12-31
➤ Subscribe Extended-release Capsules 25 mg and 200 mg ➤ Subscribe 2007-02-01
➤ Subscribe Tablets 0.125 mg, 0.5 mg, 1 mg and 1.5 mg ➤ Subscribe 2005-06-24
➤ Subscribe Capsules eq. to 75 mg base and 150 mg base ➤ Subscribe 2014-10-20
➤ Subscribe Tablets 0.75 mg ➤ Subscribe 2008-07-31
➤ Subscribe Inhalation Powder Capsules 18 mcg ➤ Subscribe 2018-05-11
➤ Subscribe Tablets 5 mg/500 mg5 mg/1000 mg12.5 mg/500 mg12.5 mg/1000 mg ➤ Subscribe 2018-08-01
➤ Subscribe Extended-release Tablets 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg ➤ Subscribe 2010-06-01
➤ Subscribe Extended-release Tablets 5 mg/1000 mg10 mg/1000 mg12.5 mg/1000 mg25 mg/1000 mg ➤ Subscribe 2018-08-01
➤ Subscribe Tablets 20 mg, 30 mg and 40 mg ➤ Subscribe 2017-07-12
➤ Subscribe Tablets 10 mg and 25 mg ➤ Subscribe 2018-08-01
➤ Subscribe Tablets 20 mg, 40 mg and 80 mg ➤ Subscribe 2006-12-26
➤ Subscribe Tablets 80 mg/25 mg ➤ Subscribe 2009-02-27
➤ Subscribe Capsules 100 mg and 150 mg ➤ Subscribe 2018-10-15
➤ Subscribe Tablets 0.25 mg ➤ Subscribe 2005-05-27
➤ Subscribe Capsules eq. to 110 mg base ➤ Subscribe 2015-12-15
➤ Subscribe Oral Suspension 7.5 mg/5 mL ➤ Subscribe 2009-12-17

Supplementary Protection Certificates for BOEHRINGER INGELHEIM Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1485094 C20120023 00122 Estonia   Start Trial PRODUCT NAME: DABIGATRAANETEKSILAAT (MESUELAADINA);REG NO/DATE: K(2008)1180 20.03.2008
0966454 08C0025 France   Start Trial PRODUCT NAME: DABIGATRAN - ETEXILATE ET SES SELS EN PARTICULIER DABIGATRAN ETEXILATE MESILATE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/442/001 DU 20080318; REGISTRATION NO/DATE AT EEC: EU/1/08/442/001 DU 20080318
1562603 122014000018 Germany   Start Trial PRODUCT NAME: OLODATEROL, OPTISCHE ISOMERE DAVON, MISCHUNGEN VON ISOMEREN DAVON, SAEUREADDITIONSSALZE DAVON MIT PHARMAKOLOGISCH UNBEDENKLICHEN SAEUREN, SOWIE SOLVATE UND/ODER HYDRATE DAVON, INSBESONDERE OLODATEROL UND OLODATEROLHYDROCHLORID; NAT. REGISTRATION NO/DATE: 87146.00.00 20131126; FIRST REGISTRATION: MALTA MA 211/00401 20130918
1830843 PA2015025 Lithuania   Start Trial PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150115
1532149 C 2012 003 Romania   Start Trial PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-IL)-7-BUT-2-INIL-3-METIL-1-(4-METILCHINAZOLIN-2-ILMETIL)3,7-DIHIDROPURIN-2,6-DIONA, ENANTIOMERII SI SARURILE LOR IN SPECIAL LINAGLIPTIN - LINAGLIPTIN, ENANTIOMERIISI SARURILE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/707/001 - RO EU/1/11/707/011; DATE OF NATIONAL AUTHORISATION: 20110824; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/707/001 - EU/1/11/707/011; DATE OF FIRST AUTHORISATION IN EEA: 20110824
2525812 C20170024 00247 Estonia   Start Trial PRODUCT NAME: IDARUTSIZUMAB;REG NO/DATE: EU/1/15/1056 24.11.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Colorcon
Dow
Moodys
Harvard Business School
AstraZeneca
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.