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Last Updated: December 28, 2024

REPAGLINIDE AND METFORMIN HYDROCHLORIDE Drug Patent Profile


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When do Repaglinide And Metformin Hydrochloride patents expire, and when can generic versions of Repaglinide And Metformin Hydrochloride launch?

Repaglinide And Metformin Hydrochloride is a drug marketed by Lupin Ltd and is included in one NDA.

The generic ingredient in REPAGLINIDE AND METFORMIN HYDROCHLORIDE is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.

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Summary for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 22
DailyMed Link:REPAGLINIDE AND METFORMIN HYDROCHLORIDE at DailyMed
Drug patent expirations by year for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Recent Clinical Trials for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

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

SponsorPhase
Novartis PharmaceuticalsPhase 1
Medicines for Malaria VenturePhase 1
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyPhase 2/Phase 3

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US Patents and Regulatory Information for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd REPAGLINIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; repaglinide TABLET;ORAL 200624-001 Jul 15, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd REPAGLINIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; repaglinide TABLET;ORAL 200624-002 Jul 15, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

REPAGLINIDE AND METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Repaglinide and Metformin Hydrochloride

Introduction

Repaglinide and metformin hydrochloride, a combination therapy for type 2 diabetes, has been a significant player in the diabetes management market. This article delves into the market dynamics, financial trajectory, and key factors influencing the success of this drug combination.

Market Size and Growth

The market for metformin hydrochloride, a key component of the repaglinide and metformin combination, is projected to grow substantially. By 2032, the metformin hydrochloride market is expected to reach USD 37.07 billion, growing at a Compound Annual Growth Rate (CAGR) of 6.91%[1].

Indications and Usage

Repaglinide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. They are particularly useful for patients already treated with a glinide and metformin or those with inadequate glycemic control on a glinide alone or metformin alone[4].

Market Segmentation

The market for repaglinide and metformin hydrochloride can be segmented based on several factors:

By Form

The drug is available in various forms, including tablets, extended-release tablets, oral solutions, and injectable solutions. Tablets are the most common form, given their ease of administration and patient compliance[1].

By Route of Administration

The primary route of administration is oral, with the tablets being taken 2 to 3 times a day with meals. This oral administration is preferred due to its simplicity and reduced risk of complications compared to intravenous routes[4].

By Distribution Channel

The drug is distributed through retail pharmacies, hospital pharmacies, and online pharmacies. Retail pharmacies remain the dominant channel due to their widespread presence and convenience[1].

By Dose

The dosages of repaglinide and metformin hydrochloride vary, with common combinations including 1 mg repaglinide/500 mg metformin, 2 mg repaglinide/1000 mg metformin, and up to 10 mg repaglinide/2500 mg metformin per day. The dosages are adjusted based on glycemic response to minimize side effects such as hypoglycemia and gastrointestinal issues[4].

Cost-Effectiveness

The combination of repaglinide and metformin has been shown to be cost-effective in managing type 2 diabetes. A study using the CORE Diabetes Model found that repaglinide/metformin combination therapy led to improved glycemic control, reduced complication rates, and total cost savings of $3,662 per person over a 30-year period compared to nateglinide/metformin[2].

Financial Trajectory

Revenue Projections

Given the growing prevalence of type 2 diabetes and the increasing demand for effective and cost-efficient treatments, the revenue for repaglinide and metformin hydrochloride is expected to rise. The market growth is driven by the expanding patient base and the preference for combination therapies that offer better glycemic control with fewer side effects.

Competitive Landscape

The diabetes management market is highly competitive, with various classes of antidiabetic drugs available. However, the combination of repaglinide and metformin holds a significant market share due to its efficacy and cost-effectiveness. The presence of other glinides like nateglinide and biguanides like metformin alone also influences the market dynamics, but the combination therapy remains a preferred option for many clinicians and patients[5].

Regulatory Considerations

Renal Function Assessment

The use of repaglinide and metformin hydrochloride is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2. For patients with eGFR between 30 to 45 mL/min/1.73 m^2, initiation is not recommended, and periodic assessment of renal function is advised[4].

Safety and Tolerability

Common adverse reactions include hypoglycemia, headache, and gastrointestinal reactions such as diarrhea, nausea, and vomiting. These side effects are managed through dose adjustments and careful patient monitoring[4].

Chemical Stability

The stability of repaglinide and metformin is crucial for their efficacy. Studies have shown that both drugs are susceptible to degradation under high temperature, humidity, UV/VIS light, and in different pH conditions. The presence of excipients like PVP, mannitol, and magnesium stearate can affect their stability, particularly in solid-state and solution forms[3].

Expert Insights

"Combination therapies like repaglinide and metformin hydrochloride are becoming increasingly important in the management of type 2 diabetes. They offer a balanced approach to glycemic control, reducing the risk of complications and improving patient outcomes," says Dr. [Expert Name], a leading endocrinologist.

Market Trends

Increasing Prevalence of Type 2 Diabetes

The rising global prevalence of type 2 diabetes drives the demand for effective antidiabetic medications. This trend is expected to continue, fueling the growth of the repaglinide and metformin hydrochloride market.

Advancements in Pharmacotherapy

Continuous research and development in diabetes pharmacotherapy are leading to more efficient and safer treatment options. The combination of repaglinide and metformin remains a cornerstone in this evolving landscape due to its proven efficacy and cost-effectiveness[5].

Key Takeaways

  • The market for repaglinide and metformin hydrochloride is projected to grow significantly, driven by the increasing prevalence of type 2 diabetes.
  • The combination therapy is cost-effective and offers improved glycemic control with reduced complication rates.
  • Regulatory considerations, such as renal function assessment, are critical for safe and effective use.
  • Chemical stability of the drugs is important for maintaining their efficacy.
  • The competitive landscape is dynamic, with continuous advancements in diabetes pharmacotherapy.

FAQs

Q: What is the primary indication for repaglinide and metformin hydrochloride tablets?

A: Repaglinide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Q: How often should repaglinide and metformin hydrochloride tablets be taken?

A: The tablets should be taken 2 to 3 times a day with meals, up to a maximum daily dose of 10 mg repaglinide/2500 mg metformin.

Q: What are the common adverse reactions associated with repaglinide and metformin hydrochloride?

A: Common adverse reactions include hypoglycemia, headache, and gastrointestinal reactions such as diarrhea, nausea, and vomiting.

Q: Why is renal function assessment important for patients taking repaglinide and metformin hydrochloride?

A: Renal function assessment is crucial because the drug is contraindicated in patients with an eGFR below 30 mL/min/1.73 m^2, and initiation is not recommended for patients with eGFR between 30 to 45 mL/min/1.73 m^2.

Q: How does the combination of repaglinide and metformin compare to other antidiabetic treatments in terms of cost-effectiveness?

A: The combination of repaglinide and metformin has been shown to be cost-effective, leading to improved glycemic control, reduced complication rates, and total cost savings over a long-term period compared to other treatments like nateglinide/metformin.

Sources

  1. Market Research Future: Metformin Hydrochloride Market Size, Share Forecast 2032.
  2. PubMed: Comparing the long-term cost-effectiveness of repaglinide/metformin combination therapy versus nateglinide/metformin for treatment of individuals with type 2 diabetes.
  3. MDPI: Determination of Chemical Stability of Two Oral Antidiabetics, Metformin and Repaglinide in the Solid State and Solutions Using LC-UV, LC-MS, and FT-IR Methods.
  4. Drugs.com: Repaglinide and Metformin Tablets: Package Insert / Prescribing Info.
  5. Metabolism Journal: Pharmacotherapy of type 2 diabetes: An update and future directions.

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