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Last Updated: November 22, 2024

REPAGLINIDE - Generic Drug Details


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What are the generic drug sources for repaglinide and what is the scope of patent protection?

Repaglinide is the generic ingredient in two branded drugs marketed by Gemini Labs Llc, Actavis Totowa, Aurobindo Pharma Ltd, Chartwell Rx, Kenton, Macleods Pharms Ltd, Norvium Bioscience, Padagis Us, and Sun Pharm Inds Inc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for repaglinide. Seven suppliers are listed for this compound.

Summary for REPAGLINIDE
Drug Prices for REPAGLINIDE

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Recent Clinical Trials for REPAGLINIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and CompanyPhase 1
PfizerPhase 1
Eli Lilly and CompanyPhase 1

See all REPAGLINIDE clinical trials

Pharmacology for REPAGLINIDE
Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists
Paragraph IV (Patent) Challenges for REPAGLINIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PRANDIN Tablets repaglinide 0.5 mg*, 1 mg and 2 mg 020741 1 2005-02-10

US Patents and Regulatory Information for REPAGLINIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx REPAGLINIDE repaglinide TABLET;ORAL 078555-002 Jan 22, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd REPAGLINIDE repaglinide TABLET;ORAL 207209-002 Mar 22, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd REPAGLINIDE repaglinide TABLET;ORAL 207209-003 Mar 22, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 REPAGLINIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gemini Labs Llc PRANDIN repaglinide TABLET;ORAL 020741-003 Dec 22, 1997 ⤷  Sign Up ⤷  Sign Up
Gemini Labs Llc PRANDIN repaglinide TABLET;ORAL 020741-002 Dec 22, 1997 ⤷  Sign Up ⤷  Sign Up
Gemini Labs Llc PRANDIN repaglinide TABLET;ORAL 020741-002 Dec 22, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for REPAGLINIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Accord Healthcare S.L.U. Repaglinide Accord repaglinide EMEA/H/C/002318
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Authorised yes no no 2011-12-22
Teva Pharma B.V. Repaglinide Teva repaglinide EMEA/H/C/001067
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Authorised yes no no 2009-06-28
Krka, d.d., Novo mesto Repaglinide Krka repaglinide EMEA/H/C/001066
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Authorised yes no no 2009-11-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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