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:

Harvard Business School
Mallinckrodt
Boehringer Ingelheim
Merck
McKesson
McKinsey

Last Updated: November 20, 2019

DrugPatentWatch Database Preview

GLYXAMBI Drug Profile

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Which patents cover Glyxambi, and what generic alternatives are available?

Glyxambi is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and eighty-six patent family members in forty-seven countries.

The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are twenty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the empagliflozin; linagliptin profile page.

Drug patent expirations by year for GLYXAMBI
Drug Prices for GLYXAMBI

See drug prices for GLYXAMBI

Generic Entry Opportunity Date for GLYXAMBI
Generic Entry Date for GLYXAMBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Litigation for GLYXAMBI

Identify potential future generic entrants

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 GLYXAMBI litigation

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

See all GLYXAMBI litigation

Synonyms for GLYXAMBI
Empagliflozin / Linagliptin
Empagliflozin and Linagliptin
Empagliflozin mixture with Linagliptin
Linagliptin and Empagliflozin
S900006430
Paragraph IV (Patent) Challenges for GLYXAMBI
Tradename Dosage Ingredient NDA Submissiondate
GLYXAMBI TABLET;ORAL empagliflozin; linagliptin 206073 2018-08-01

US Patents and Regulatory Information for GLYXAMBI

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   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 206073-002 Jan 30, 2015 RX Yes Yes   Start Trial   Start Trial 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 GLYXAMBI

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for GLYXAMBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 PA2014035,C1730131 Lithuania   Start Trial PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 200 5026-2014 Slovakia   Start Trial PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527
1532149 91889 Luxembourg   Start Trial 91889, EXPIRES: 20260824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Express Scripts
Dow
Harvard Business School
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.