PRANDIN Drug Patent Profile

When do Prandin patents expire, and what generic alternatives are available?

Prandin is a drug marketed by Gemini Labs Llc and is included in one NDA.

The generic ingredient in PRANDIN is repaglinide. There are sixteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the repaglinide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prandin

A generic version of PRANDIN was approved as repaglinide by SUN PHARM INDS INC on July 11^th, 2013.

Summary for PRANDIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	3
Patent Applications:	4,497
Drug Prices:	Drug price information for PRANDIN
What excipients (inactive ingredients) are in PRANDIN?	PRANDIN excipients list
DailyMed Link:	PRANDIN at DailyMed

See drug prices for PRANDIN

Recent Clinical Trials for PRANDIN

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

Sponsor	Phase
Pfizer	Phase 1
University Hospital Birmingham	Phase 4
University of Leicester	Phase 4

See all PRANDIN clinical trials

Paragraph IV (Patent) Challenges for PRANDIN

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 PRANDIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997		DISCN	Yes	No
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997		DISCN	Yes	No
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997		DISCN	Yes	No

Expired US Patents for PRANDIN

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 PRANDIN

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

International Patents for PRANDIN

See the table below for patents covering PRANDIN around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1011673
Japan	H0739406
Spain	533207
Finland	83417

Supplementary Protection Certificates for PRANDIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0147850	SPC/GB98/042	United Kingdom		PRODUCT NAME: 2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3-METHYL-1-BUTYL)-AMINOCARBONYLMETHYL)-BENZOIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT AND/OR OPTIONALLY IN THE FORM OF AN ENANTIOMER, IN PARTICULAR (S)(+)-2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3; REGISTERED: UK EU/1/98/076/001 19980817; UK EU/1/98/076/002 19980817; UK EU/1/98/076/003 19980817; UK EU/1/98/076/004 19980817; UK EU/1/98/076/005 19980817; UK EU/1/98/076/006 19980817; UK EU/1/98/076/019 19980817; UK EU/1/98/076/020 19980817; UK EU/1/98/076/021 19980817; UK EU/1/98/076/013 19980817; UK EU/1/98/076/014 19980817; UK EU/1/98/076/015 19980817; UK EU/1/98/076/016 19980817; UK EU/1/98/076/017 19980817; UK EU/1/98/
0147850	99C0002	Belgium		PRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817

PRANDIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: PRANDIN

Introduction

PRANDIN, also known as repaglinide, is an oral blood glucose-lowering drug of the meglitinide class, used in the management of type 2 diabetes mellitus. This article delves into the market dynamics and financial trajectory of PRANDIN, highlighting its unique position in the diabetes management market, key drivers, challenges, and financial performance over the years.

Mechanism of Action and Clinical Use

PRANDIN works by stimulating the pancreas to release insulin, particularly after meals, making it an effective tool for managing postprandial glucose spikes. This rapid-acting mechanism aligns with the trend toward personalized medicine, providing healthcare providers with a valuable option for achieving optimal glycemic control[1][4].

Market Drivers

Several factors drive the market for PRANDIN:

Rising Prevalence of Type 2 Diabetes

The increasing global prevalence of type 2 diabetes is a significant driver for the demand of antidiabetic medications like PRANDIN. As more people are diagnosed with this chronic condition, the need for effective management tools grows[4].

Unique Rapid-Acting Mechanism

PRANDIN's ability to rapidly stimulate insulin release after meals makes it a crucial tool for addressing postprandial glucose spikes, a critical concern in diabetes management[4].

Combination Therapies

Healthcare providers often prescribe PRANDIN alongside other antidiabetic drugs to achieve better glycemic control while minimizing side effects. This trend toward combination therapies further boosts the market for PRANDIN[4].

Market Challenges

Despite its unique benefits, PRANDIN faces several market challenges:

Generic Competition

The introduction of generic versions of PRANDIN has significantly impacted its sales. For instance, after generic competition began in August 2013, Novo Nordisk reported much lower sales for the product[3].

Drug-Drug Interactions

PRANDIN's metabolism is influenced by cytochrome P450 enzymes 2C8 and 3A4. Interactions with other drugs that inhibit or induce these enzymes can alter PRANDIN's plasma concentrations, necessitating dose adjustments and potentially affecting its market appeal[1].

Regulatory and Reimbursement Issues

Changes in reimbursement policies and regulatory pressures can impact the sales of PRANDIN. For example, the loss of reimbursement for certain diabetes products with large pharmacy benefit managers has negatively affected sales[3].

Financial Performance

The financial trajectory of PRANDIN is closely tied to the broader performance of its manufacturer, Novo Nordisk.

Sales Growth and Decline

In the early 2010s, Novo Nordisk experienced robust sales growth driven by key products like Victoza®, Tresiba®, and Levemir®, but PRANDIN's sales declined due to generic competition. By 2014, the sales growth of Novo Nordisk's diabetes care products, including PRANDIN, was affected by various factors such as generic competition, reduced reimbursement, and inventory adjustments[3].

Regional Performance

While PRANDIN's sales have been impacted globally, regional performances vary. For instance, North America, International Operations, and Region China have been key contributors to Novo Nordisk's overall sales growth, though PRANDIN's specific performance in these regions has been less stellar due to the aforementioned challenges[3][5].

Financial Impact

The decline in PRANDIN sales has been part of a broader trend affecting Novo Nordisk's financial performance. Despite this, the company has maintained overall sales growth driven by other successful products. For example, in 2016, Novo Nordisk reported sales growth of 6% in local currencies, with key products like Victoza®, Tresiba®, and Saxenda® driving this growth[2].

Clinical Trials and Safety Profile

PRANDIN has been extensively studied in clinical trials, involving over 2,900 individuals with type 2 diabetes. These trials have shown that PRANDIN's adverse event profile is generally comparable to that of sulfonylurea drugs, with mild or moderate hypoglycemia being one of the most common adverse events[1].

Cardiovascular Events

Studies comparing PRANDIN to sulfonylurea drugs have shown that the incidence of cardiovascular events such as angina, hypertension, and myocardial infarction is similar between the two treatments, indicating that PRANDIN does not significantly increase the risk of these events[1].

Conclusion

PRANDIN remains a valuable tool in the management of type 2 diabetes due to its rapid-acting mechanism and effectiveness in controlling postprandial glucose spikes. However, its market dynamics are influenced by factors such as generic competition, drug-drug interactions, and regulatory challenges. Despite these challenges, Novo Nordisk has maintained a strong financial performance driven by its portfolio of successful diabetes care products.

Key Takeaways

• Unique Mechanism: PRANDIN's rapid-acting mechanism makes it effective for managing postprandial glucose spikes.
• Market Drivers: Rising prevalence of type 2 diabetes and trends toward combination therapies drive demand.
• Challenges: Generic competition, drug-drug interactions, and regulatory issues impact sales.
• Financial Performance: Overall sales growth for Novo Nordisk is driven by other key products despite PRANDIN's decline.
• Clinical Safety: PRANDIN's safety profile is comparable to sulfonylurea drugs with a similar risk of cardiovascular events.

FAQs

What is PRANDIN used for?

PRANDIN (repaglinide) is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

How does PRANDIN work?

PRANDIN stimulates the pancreas to release insulin, particularly after meals, helping to manage postprandial glucose spikes.

What are the common adverse events associated with PRANDIN?

Common adverse events include mild or moderate hypoglycemia, hyperglycemia, and related symptoms.

Can PRANDIN be used with other medications?

Yes, but caution is advised due to potential drug-drug interactions, especially with inhibitors and inducers of cytochrome P450 enzymes 2C8 and 3A4.

How has generic competition affected PRANDIN sales?

Generic competition has significantly reduced PRANDIN sales since its introduction in August 2013.

Sources

1. Drugs.com: PRANDIN (repaglinide) - Package Insert / Prescribing Information.
2. Novo Nordisk Annual Report 2016: Sales growth and financial performance.
3. Novo Nordisk Annual Report 2014: Impact of generic competition and regulatory changes.
4. IMARC Group: Repaglinide (Prandin) Manufacturing Plant Report.
5. Novo Nordisk Annual Report 2012: Financial performance and market dynamics.