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:

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Moodys
Johnson and Johnson

Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Empagliflozin; linagliptin - Generic Drug Details

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What are the generic drug sources for empagliflozin; linagliptin and what is the scope of patent protection?

Empagliflozin; linagliptin is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin; linagliptin has four hundred and eighty-six patent family members in forty-seven countries.

There are twenty-two drug master file entries for empagliflozin; linagliptin. Two suppliers are listed for this compound.

Summary for empagliflozin; linagliptin
Recent Clinical Trials for empagliflozin; linagliptin

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SponsorPhase
Hospital Regional de Alta Especialidad del BajioPhase 3
Universidad de GuanajuatoPhase 3
M.H.H. KramerPhase 4

See all empagliflozin; linagliptin clinical trials

Recent Litigation for empagliflozin; linagliptin

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District Court Litigation
Case NameDate
Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited2019-08-28
Boehringer Ingelheim Pharmaceuticals Inc. v. Cadila Healthcare Limited2019-07-11
Boehringer Ingelheim Pharmaceuticals Inc. v. Sun Pharmaceutical Industries Limited2018-11-08

See all empagliflozin; linagliptin litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2016-08-10
Mylan Pharmaceuticals Inc.2016-08-10

See all empagliflozin; linagliptin litigation

Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; LINAGLIPTIN
Tradename Dosage Ingredient NDA Submissiondate
GLYXAMBI TABLET;ORAL empagliflozin; linagliptin 206073 2018-08-01

US Patents and Regulatory Information for empagliflozin; linagliptin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No   Start Trial   Start Trial Y Y   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 empagliflozin; linagliptin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015   Start Trial   Start Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015   Start Trial   Start Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015   Start Trial   Start Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for empagliflozin; linagliptin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 1490061-7 Sweden   Start Trial PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
2187879 2017020 Norway   Start Trial PRODUCT NAME: EMPAGLIFLOZIN OG LINAGLIPTIN; REG. NO/DATE: EU/1/16/1146-001-018 20161209
2187879 PA2017014 Lithuania   Start Trial PRODUCT NAME: EMPAGLIFLOZINO IR LINAGLIPTINO DERINYS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1146/001 - EU/1/16/1146/018 20161111
2187879 CA 2017 00019 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
AstraZeneca
Moodys
Medtronic
McKinsey

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