PRANDIMET Drug Patent Profile

Which patents cover Prandimet, and when can generic versions of Prandimet launch?

Prandimet is a drug marketed by Novo Nordisk Inc and is included in one NDA.

The generic ingredient in PRANDIMET 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.

Summary for PRANDIMET

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	38
DailyMed Link:	PRANDIMET at DailyMed

Paragraph IV (Patent) Challenges for PRANDIMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRANDIMET	Tablets	metformin hydrochloride; repaglinide	1 mg/500 mg and 2 mg/500 mg	022386	1	2009-04-09

US Patents and Regulatory Information for PRANDIMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-001	Jun 23, 2008		DISCN	Yes	No
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-002	Jun 23, 2008		DISCN	Yes	No

Expired US Patents for PRANDIMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-001	Jun 23, 2008	6,677,358
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-002	Jun 23, 2008	RE37035
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-001	Jun 23, 2008	RE37035
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-002	Jun 23, 2008	6,677,358

International Patents for PRANDIMET

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

Country	Patent Number	Title	Estimated Expiration
South Korea	900005320
Australia	577815
Spain	8802145
Spain	545879
Denmark	1011673

Supplementary Protection Certificates for PRANDIMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	12C0028	France		PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1412357	PA2008013	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1261586	132012902044560	Italy		PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357	77 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408

PRANDIMET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PrandiMet

Introduction to PrandiMet

PrandiMet is a combination antidiabetic drug that includes repaglinide, a meglitinide, and metformin hydrochloride, a biguanide. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin HCl, or who have inadequate glycemic control on either medication alone[1].

Market Context

The antidiabetic drug market has seen significant growth and evolution over the past decade, driven by increasing prevalence of diabetes and advancements in treatment options.

Market Trends

• The market for antidiabetic drugs has been influenced by the introduction of new-generation, non-insulin drugs. These include combination therapies like PrandiMet, which offer the convenience of two therapies in one tablet[3].
• The trend towards combination therapies is partly driven by the need for better glycemic control and the convenience of reduced pill burden for patients.

Sales Performance

• While specific sales data for PrandiMet is not widely available, the overall market for antidiabetic drugs, including combination therapies, has shown fluctuating but generally stable sales. For example, sales for other antidiabetic combinations, including those with metformin, have ranged from $41 million to $106 million over the years 2012-2021[3].

Financial Trajectory

Revenue Growth

• PrandiMet, as a part of the broader antidiabetic market, benefits from the growing demand for effective diabetes management. However, its financial performance is tied to the overall sales of its constituent components and the competitive landscape.
• The convenience of a combination tablet can drive modest growth, as seen with similar products like Prandin, which has experienced modest growth in new prescriptions (NRx)[4].

Competitive Landscape

• The antidiabetic market is highly competitive, with major players like Novo Nordisk dominating the landscape with products such as Victoza (liraglutide), Tresiba, and Saxenda. These products have driven significant sales growth for Novo Nordisk, but PrandiMet operates in a different segment focused on oral combination therapies[2][5].

Pricing and Market Dynamics

• The pricing environment for antidiabetic drugs is complex and influenced by regulatory and market factors. For instance, the pricing pressure in the long-acting insulin market in the US has impacted overall sales for some companies, but combination oral therapies like PrandiMet may be less affected by these pressures[5].

Usage and Prescribing Trends

Indications and Usage

• PrandiMet is specifically indicated for adults with type 2 diabetes who are already on a meglitinide and metformin HCl or who have inadequate control on either medication alone. This targeted indication helps in maintaining a stable patient base[1].

Dosage and Administration

• The dosage of PrandiMet is individualized based on the patient’s current regimen, effectiveness, and tolerability. This flexibility can influence prescribing decisions and patient adherence, potentially impacting sales[1].

Challenges and Opportunities

Renal Impairment Considerations

• PrandiMet is contraindicated in patients with severe renal impairment (eGFR below 30 mL/min/1.73 m^2), which can limit its use in certain patient populations. However, this also highlights the need for careful patient selection and monitoring, which can be a selling point for healthcare providers looking for safe and effective options[1].

Patient Compliance

• The convenience of a single tablet containing two active ingredients can improve patient compliance, which is a significant factor in the long-term success and financial trajectory of the drug.

Key Takeaways

• Market Position: PrandiMet operates in a competitive antidiabetic market but offers a unique combination of repaglinide and metformin, catering to specific patient needs.
• Financial Performance: While specific sales data is limited, the drug benefits from the overall growth in the antidiabetic market and the trend towards combination therapies.
• Prescribing Trends: The drug's usage is guided by its indications and dosage flexibility, which can influence prescribing decisions and patient adherence.
• Challenges and Opportunities: Renal impairment considerations and patient compliance are crucial factors that can impact the drug's financial trajectory.

FAQs

Q: What are the main components of PrandiMet?

• PrandiMet is a combination of repaglinide, a meglitinide, and metformin hydrochloride, a biguanide[1].

Q: What is the primary indication for PrandiMet?

• PrandiMet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin HCl or who have inadequate glycemic control on either medication alone[1].

Q: How is the dosage of PrandiMet determined?

• The dosage of PrandiMet is individualized based on the patient’s current regimen, effectiveness, and tolerability[1].

Q: Can PrandiMet be used in patients with type 1 diabetes or diabetic ketoacidosis?

• No, PrandiMet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis[1].

Q: What are the renal impairment considerations for PrandiMet?

• PrandiMet is contraindicated in patients with an eGFR below 30 mL/min/1.73 m^2, and its initiation is not recommended in patients with an eGFR between 30 – 45 mL/min/1.73 m^2[1].

Sources

1. Drugs.com: PrandiMet: Package Insert / Prescribing Information.
2. Novo Nordisk: 2012 Annual Report.
3. Canada.ca: Market Intelligence Report: Antidiabetic Drugs, 2012-2021.
4. MM+M: PrandiMet.
5. AnnualReports.com: Novo Nordisk 2017 Annual Report.