REPAGLINIDE - Generic Drug Details

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

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	66
Patent Applications:	7,329
Drug Prices:	Drug price trends for REPAGLINIDE
What excipients (inactive ingredients) are in REPAGLINIDE?	REPAGLINIDE excipients list
DailyMed Link:	REPAGLINIDE at DailyMed

See drug prices for REPAGLINIDE

Recent Clinical Trials for REPAGLINIDE

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

Sponsor	Phase
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company	Phase 1
Pfizer	Phase 1
Eli Lilly and Company	Phase 1

See all REPAGLINIDE clinical trials

Pharmacology for REPAGLINIDE

Drug Class	Glinide
Mechanism of Action	Potassium Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for REPAGLINIDE

A10BX	Other blood glucose lowering drugs, excl. insulins
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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
Kenton	REPAGLINIDE	repaglinide	TABLET;ORAL	091517-003	Apr 24, 2015		DISCN	No	No
Kenton	REPAGLINIDE	repaglinide	TABLET;ORAL	091517-002	Apr 24, 2015		DISCN	No	No
Actavis Totowa	REPAGLINIDE	repaglinide	TABLET;ORAL	090008-001	Jan 22, 2014		DISCN	No	No
Norvium Bioscience	REPAGLINIDE	repaglinide	TABLET;ORAL	090252-003	Jan 22, 2014		DISCN	No	No

Expired US Patents for REPAGLINIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997	5,312,924
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997	6,143,769
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997	4,873,080
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997	6,677,358

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
Krka, d.d., Novo mesto	Enyglid	repaglinide	EMEA/H/C/001065 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	2009-10-13

REPAGLINIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Repaglinide

Introduction

Repaglinide, marketed under names such as Prandin, NovoNorm, and GlucoNorm, is an oral insulin secretagogue used in the management of type 2 diabetes mellitus. This article delves into the market dynamics and financial trajectory of repaglinide, highlighting its clinical efficacy, cost-effectiveness, market trends, and financial performance.

Clinical Efficacy of Repaglinide

Repaglinide is known for its ability to reduce postprandial glucose excursions by targeting early-phase insulin release. Clinical trials have shown that repaglinide achieves significant improvements in glycaemic control, as measured by glycosylated haemoglobin (HbA1c), fasting blood glucose (FBG), and postprandial blood glucose (PPBG) levels, comparable to other oral antidiabetic agents like glibenclamide (glyburide) and glipizide[1].

Cost-Effectiveness Analysis

Several cost-effectiveness analyses have been conducted to evaluate the economic impact of repaglinide in the treatment of type 2 diabetes. These studies, often using models like the CORE Diabetes Model, have projected long-term outcomes and costs associated with repaglinide-based regimens.

• In North American analyses, repaglinide plus metformin was found to be more cost-effective than nateglinide plus metformin, with a higher probability of being cost-saving over a 30-year period. Repaglinide/metformin showed a 96% probability of having incremental costs per quality-adjusted life year (QALY) gained of $20,000 or less[3].
• A Canadian analysis indicated a favourable incremental cost-effectiveness ratio for patients switching from sulphonylureas to repaglinide, highlighting potential long-term savings and reduced cardiovascular complications[1].

Market Trends

The global market for repaglinide is part of the broader diabetes care market, which is experiencing significant growth.

• The repaglinide market was valued at USD 85 billion in 2023 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.6% from 2024 to 2031, reaching USD 109 billion by 2031[4].
• The increasing prevalence of type 2 diabetes and the need for effective and flexible treatment options are driving this growth.

Financial Performance

Repaglinide is one of the products within the portfolio of pharmaceutical companies like Novo Nordisk, which has a strong presence in the diabetes care market.

• Novo Nordisk's financial performance has been robust, with sales growth driven by key products such as Victoza (liraglutide), Tresiba, and Saxenda. While repaglinide is not as prominently featured in recent annual reports, it remains a part of the company's comprehensive diabetes treatment offerings[2][5].

Regional Market Dynamics

The sales performance of repaglinide and other diabetes treatments varies by region.

• North America has been a significant contributor to the growth of Novo Nordisk's diabetes care segment, although the company faced challenges in 2017 due to increased rebates to pharmaceutical benefit managers (PBMs) and lower prices for some insulin products[5].
• International Operations and Region China have also shown strong growth, indicating a diverse and expanding market for diabetes treatments globally[2].

Competitive Landscape

The diabetes care market is highly competitive, with numerous treatment options available.

• Repaglinide competes with other oral antidiabetic agents and insulin analogues. The market is crowded with products from various manufacturers, and companies must negotiate rebates and access agreements to ensure broad market coverage[5].
• The increasing negotiating power of PBMs has led to higher rebates and lower net prices for some products, affecting the financial performance of pharmaceutical companies in this sector[5].

Patient and Healthcare System Impact

The economic burden of diabetes is substantial, and the choice of treatment can significantly impact both patients and healthcare systems.

• Studies have shown that the mean annual cost per patient with diabetes can be as high as $2,928, with a significant portion of healthcare expenditure directed towards diabetes care. Repaglinide, by offering a cost-effective option with favorable glycaemic control, can help reduce these costs over the long term[1].

Regulatory and Approval Processes

The regulatory environment plays a crucial role in the market dynamics of repaglinide.

• Repaglinide has been approved in various countries and is subject to ongoing regulatory reviews and updates. The approval and launch of new products, such as Tresiba and Ryzodeg, also influence the market landscape for existing treatments like repaglinide[2].

Future Outlook

The future outlook for repaglinide is tied to the broader trends in diabetes care and the pharmaceutical industry.

• With the projected increase in the prevalence of type 2 diabetes, the demand for effective and cost-efficient treatments is expected to rise. Repaglinide, with its established clinical efficacy and cost-effectiveness, is likely to remain a viable option in the treatment arsenal[1][4].

Key Takeaways

• Clinical Efficacy: Repaglinide is effective in reducing postprandial glucose excursions and achieving glycaemic control comparable to other oral antidiabetic agents.
• Cost-Effectiveness: Repaglinide-based regimens have been shown to be cost-effective in long-term analyses, particularly when combined with metformin.
• Market Trends: The global repaglinide market is growing, driven by the increasing prevalence of type 2 diabetes.
• Financial Performance: Repaglinide contributes to the overall financial performance of pharmaceutical companies like Novo Nordisk, although it is not as prominently featured as some other products.
• Regional Dynamics: Sales performance varies by region, with North America and International Operations being key contributors.
• Competitive Landscape: The market is highly competitive, with repaglinide competing against various other treatments.

FAQs

Q1: What is repaglinide used for?

Repaglinide is used in the management of type 2 diabetes mellitus to reduce postprandial glucose excursions by targeting early-phase insulin release.

Q2: How does repaglinide compare to other oral antidiabetic agents?

Repaglinide achieves similar or better glycaemic control compared to agents like glibenclamide (glyburide) and glipizide, as measured by HbA1c, FBG, and PPBG levels[1].

Q3: What are the cost-effectiveness findings for repaglinide?

Repaglinide/metformin has been shown to be cost-effective, with a high probability of having incremental costs per QALY gained of $20,000 or less, and it is likely to be cost-saving compared to nateglinide/metformin[3].

Q4: How is the market for repaglinide expected to grow?

The global repaglinide market is expected to grow at a CAGR of 3.6% from 2024 to 2031, reaching USD 109 billion by 2031[4].

Q5: What are the key factors influencing the financial performance of repaglinide?

The financial performance of repaglinide is influenced by its clinical efficacy, cost-effectiveness, market competition, and regional sales dynamics, as well as the negotiating power of PBMs and regulatory environments[1][2][5].

Sources

1. Pharmacoeconomic Review: "Repaglinide: A Review of Its Use in Type 2 Diabetes Mellitus" - PubMed[1].
2. Novo Nordisk Annual Report 2012: Novo Nordisk[2].
3. Cost-Effectiveness Analysis: "Comparing the Long-Term Cost-Effectiveness of Repaglinide/Metformin vs Nateglinide/Metformin in Type 2 Diabetes" - PubMed[3].
4. Market Research: "Global Repaglinide Market Size and Forecast" - Market Research Intellect[4].
5. Novo Nordisk Annual Report 2016: Novo Nordisk[5].