NATEGLINIDE Drug Patent Profile

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

Nateglinide is a drug marketed by Alvogen, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Rising, Strides Pharma, Teva Pharms, Watson Labs, and Zydus Pharms. and is included in eight NDAs.

The generic ingredient in NATEGLINIDE is nateglinide. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nateglinide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nateglinide

A generic version of NATEGLINIDE was approved as nateglinide by DR REDDYS LABS LTD on September 9^th, 2009.

Summary for NATEGLINIDE

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	24
Patent Applications:	4,159
Drug Prices:	Drug price information for NATEGLINIDE
DailyMed Link:	NATEGLINIDE at DailyMed

See drug prices for NATEGLINIDE

Recent Clinical Trials for NATEGLINIDE

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

Sponsor	Phase
Ministry of Health, Kuwait	Phase 4
Dasman Diabetes Institute	Phase 4
Kuwait University	Phase 4

See all NATEGLINIDE clinical trials

Pharmacology for NATEGLINIDE

Drug Class	Glinide
Mechanism of Action	Potassium Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NATEGLINIDE

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 NATEGLINIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STARLIX	Tablets	nateglinide	60 mg and 120 mg	021204		2004-12-22

US Patents and Regulatory Information for NATEGLINIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	NATEGLINIDE	nateglinide	TABLET;ORAL	077467-002	Sep 9, 2009		DISCN	No	No
Alvogen	NATEGLINIDE	nateglinide	TABLET;ORAL	205055-001	Dec 11, 2015		DISCN	No	No
Rising	NATEGLINIDE	nateglinide	TABLET;ORAL	205544-001	Jun 18, 2018	AB	RX	No	No
Rising	NATEGLINIDE	nateglinide	TABLET;ORAL	205544-002	Jun 18, 2018	AB	RX	No	No
Cadila Pharms Ltd	NATEGLINIDE	nateglinide	TABLET;ORAL	206432-002	Apr 19, 2019	AB	RX	No	No

EU/EMA Drug Approvals for NATEGLINIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Starlix	nateglinide	EMEA/H/C/000335 Nateglinide is indicated for combination therapy with metformin in type-2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.	Withdrawn	no	no	no	2001-04-03
Novartis Europharm Ltd.	Trazec	nateglinide	EMEA/H/C/000383 Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.	Withdrawn	no	no	no	2001-04-03

Market Dynamics and Financial Trajectory for Nateglinide

Introduction to Nateglinide

Nateglinide, marketed under the brand name Starlix, is an oral antidiabetic drug used to control blood sugar levels in patients with type 2 diabetes. It works by stimulating the pancreas to release more insulin into the bloodstream. Here, we will delve into the market dynamics and financial trajectory of nateglinide.

Market Size and Growth Forecast

The global nateglinide market has been experiencing significant growth. As of 2022, the market size was valued at USD 538.23 million. It is projected to grow substantially, reaching USD 1,187.74 million by 2030, with a Compound Annual Growth Rate (CAGR) of 10.4% during the forecast period from 2023 to 2030[1].

Drivers of Market Growth

Technological Advancements

Advances in pharmaceutical research and development have led to more efficient and targeted antidiabetic medications. New formulations and drug delivery systems continue to emerge, positively impacting the nateglinide market[1].

Increasing Diabetes Prevalence

The rising global burden of type 2 diabetes is a major driver for the nateglinide market. The growing diabetic population has increased the demand for effective oral antidiabetic drugs like nateglinide[1].

Increasing Diabetes Awareness

There is a growing emphasis on preventive healthcare and increasing awareness about diabetes. This trend can lead to more people seeking early diagnosis and effective management, thereby increasing the demand for antidiabetic medications like nateglinide[1].

Market Segmentation

The nateglinide market is segmented based on several factors:

Therapy Type

• Monotherapy is expected to dominate the therapy segment due to increasing investment in healthcare. However, combinational therapy is also gaining traction as it offers comprehensive management of diabetes[1].

Indication

• Diabetes is the primary indication, but nateglinide is also used for other conditions such as obesity[1].

End-Users

• Hospitals, homecare, specialty clinics, and other healthcare settings are key end-users of nateglinide[1].

Distribution Channel

• The distribution channels include hospital pharmacy, online pharmacy, and retail pharmacy. North America is expected to dominate the market due to factors such as rising healthcare costs and technological advancements[1].

Regional Analysis

The global nateglinide market is analyzed across various regions, including North America, Europe, Asia-Pacific, Middle East and Africa, and South America. North America is anticipated to lead the market due to high healthcare costs, increased R&D, and technological advancements[1].

Challenges and Restraints

Patent Expiry and Generic Competition

The patent protection for nateglinide may expire, allowing generic manufacturers to enter the market with lower-priced alternatives. This could lead to increased competition, price erosion, and reduced market share for branded nateglinide products[1].

High Manufacturing Costs

The high cost associated with product manufacturing is expected to obstruct market growth. Additionally, disruptions in the supply chain and lack of favorable reimbursement scenarios in developing economies can challenge the market's growth[1].

Financial Impact and Cost-Effectiveness

Cost-Effectiveness Analysis

Studies have compared the cost-effectiveness of nateglinide with other antidiabetic drugs. For instance, a study using the CORE Diabetes Model found that repaglinide/metformin combination therapy was more cost-effective than nateglinide/metformin, with a 96% probability that the incremental costs per quality-adjusted life year gained would be $20,000 or less[3].

Market Pricing and Competition

The entry of generic versions of nateglinide can significantly impact pricing. Generic medications, which represent 90% of prescriptions in the US market, provide a financial benefit to patients but also introduce competition that can lower prices and affect the market share of branded products[2].

Expert Insights and Industry Trends

Industry experts highlight the importance of effective drug price negotiation frameworks. For example, a comparative analysis of international drug price negotiation frameworks shows that formal clinical assessments comparing new drugs with existing therapies are crucial for managing costs and ensuring value for money[2].

Key Takeaways

• The global nateglinide market is projected to grow significantly, driven by technological advancements and the increasing prevalence of type 2 diabetes.
• Monotherapy is expected to dominate the therapy segment, with North America leading the market.
• Challenges include patent expiry, generic competition, and high manufacturing costs.
• Cost-effectiveness analyses suggest that combination therapies may offer better value for money.
• Regional variations and distribution channels play a critical role in market dynamics.

Frequently Asked Questions (FAQs)

1. What is nateglinide used for? Nateglinide is used together with diet and exercise to control blood sugar levels in patients with type 2 diabetes. It works by stimulating the pancreas to release more insulin into the bloodstream[5].

2. What is the projected market size of nateglinide by 2030? The global nateglinide market is expected to reach USD 1,187.74 million by 2030, with a CAGR of 10.4% during the forecast period from 2023 to 2030[1].

3. What are the main drivers of the nateglinide market? The main drivers include technological advancements, increasing diabetes prevalence, and growing awareness about diabetes management[1].

4. How does the patent expiry of nateglinide affect the market? The patent expiry allows generic manufacturers to enter the market, leading to increased competition, price erosion, and reduced market share for branded nateglinide products[1].

5. Which region is expected to dominate the nateglinide market? North America is expected to dominate the market due to factors such as rising healthcare costs, increased R&D, and technological advancements[1].

Cited Sources:

1. Data Bridge Market Research - Global Nateglinide Market Size, Outlook & Growth Forecast Report By 2030.
2. Stanford Profiles - Kevin Schulman, A Comparative Analysis of International Drug Price Negotiation Frameworks.
3. PubMed - Comparing the long-term cost-effectiveness of repaglinide/metformin and nateglinide/metformin for type 2 diabetes.
4. News Channel Nebraska - Nateglinide Market 2024: Industry Share, Key Drivers, and Forecast.
5. Mayo Clinic - Nateglinide (oral route) - Description.