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Last Updated: September 18, 2020

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Details for New Drug Application (NDA): 212614

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NDA 212614 describes TRIJARDY XR, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the TRIJARDY XR profile page.

The generic ingredient in TRIJARDY XR is empagliflozin; linagliptin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; linagliptin; metformin hydrochloride profile page.
Summary for 212614
Generic Entry Opportunity Date for 212614
Generic Entry Date for 212614*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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.

Suppliers and Packaging for NDA: 212614
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0380 0597-0380-13 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-13)
TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0380 0597-0380-22 1 BOTTLE in 1 CARTON (0597-0380-22) > 7 TABLET, EXTENDED RELEASE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 212614
Tradename Dosage Ingredient NDA Submissiondate
TRIJARDY XR TABLET, EXTENDED RELEASE;ORAL empagliflozin; linagliptin; metformin hydrochloride 212614 2020-05-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;2.5MG;1GM
Approval Date:Jan 27, 2020TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 2, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
Patent:  Start TrialPatent Expiration:Apr 3, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2
Patent:  Start TrialPatent Expiration:Jun 15, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN

Expired US Patents for NDA 212614

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-001 Jan 27, 2020   Start Trial   Start Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-003 Jan 27, 2020   Start Trial   Start Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.