STARLIX Drug Patent Profile

Which patents cover Starlix, and what generic alternatives are available?

Starlix is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in STARLIX 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 Starlix

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

Summary for STARLIX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	3
Patent Applications:	4,159
Drug Prices:	Drug price information for STARLIX
What excipients (inactive ingredients) are in STARLIX?	STARLIX excipients list
DailyMed Link:	STARLIX at DailyMed

See drug prices for STARLIX

Recent Clinical Trials for STARLIX

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 4
Dr. Reddy's Laboratories Limited	Phase 1

See all STARLIX clinical trials

Paragraph IV (Patent) Challenges for STARLIX

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 STARLIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-001	Dec 22, 2000		DISCN	Yes	No
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000		DISCN	Yes	No

Expired US Patents for STARLIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-001	Dec 22, 2000
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000

EU/EMA Drug Approvals for STARLIX

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	Withdrawn	no	no	no	2001-04-03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

International Patents for STARLIX

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

Country	Patent Number	Title	Estimated Expiration
China	1635874
European Patent Office	2277517
Japan	2508949
South Africa	200202107	Method of treating metabolic disorders, especially diabetes, or a disease or condition associated with diabetes.

Supplementary Protection Certificates for STARLIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0526171	01C0044	France		PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 20000928
0526171	31/2001	Austria		PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 - EU/1/01/174/021 20010403; FIRST REGISTRATION: LI 55401.01 - 02 20000928
0196222	SPC/GB01/045	United Kingdom		PRODUCT NAME: NATEGLINIDE OR SALTS THEREOF; REGISTERED: CH 55401 20000928; CH 55402 20000928; UK EU/1/01/174/001 20010403; UK EU/1/01/174/002 20010403; UK EU/1/01/174/003 20010403; UK EU/1/01/174/004 20010403; UK EU/1/01/174/005 20010403; UK EU/1/01/174/006 20010403; UK EU/1/01/174/019 20010403; UK EU/1/01/174/020 20010403; UK EU/1/01/174/021 20010403; UK EU/1/01/174/013 20010403; UK EU/1/01/174/014 20010403; UK EU/1/01/174/015 20010403; UK EU/1/01/174/016 20010403; UK EU/1/01/174/017 20010403; UK EU/1/01/174/018 20010403; UK EU/1/01/174/007 20010403; UK EU/1/01/174/008 20010403; UK EU/1/01/174/009 20010403; UK EU/1/01/174/010 20010403; UK EU/1/01/174/011 20010403; UK EU/1/01/174/012 2001040
0526171	SPC/GB01/047	United Kingdom		PRODUCT NAME: NATEGLINIDE; REGISTERED: CH 55401 01 20000928; CH 55401 02 20000928; UK EU/1/01/174/001 20010403; UK EU/1/01/174/002 20010403; UK EU/1/01/174/003 20010403; UK EU/1/01/174/004 20010403; UK EU/1/01/174/005 20010403; UK EU/1/01/174/006 20010403; UK EU/1/01/174/007 20010403; UK EU/1/01/174/008 20010403; UK EU/1/01/174/009 20010403; UK EU/1/01/174/010 20010403; UK EU/1/01/174/011 20010403; UK EU/1/01/174/012 20010403; UK EU/1/01/174/013 20010403; UK EU/1/01/174/014 20010403; UK EU/1/01/174/015 20010403; UK EU/1/01/174/016 20010403; UK EU/1/01/174/017 20010403; UK EU/1/01/174/018 20010403; UK EU/1/01/174/019 20010403; UK EU/1/01/174/020 20010403; UK EU/1/01/174/021 20010403

Market Dynamics and Financial Trajectory for STARLIX

Introduction

STARLIX, known by its generic name nateglinide, is an oral antidiabetic drug used to treat type 2 diabetes. Here, we will delve into the market dynamics and financial trajectory of STARLIX, considering its position within the broader antidiabetic drugs market.

Market Context

The global antidiabetic drugs market is experiencing significant growth, driven by increasing prevalence of diabetes and advancements in treatment options. The market size is projected to grow from $79.25 billion in 2023 to $153.98 billion by 2032, at a CAGR of 7.0% during the forecast period[1].

STARLIX in the Antidiabetic Drugs Market

STARLIX is a member of the meglitinide class of drugs, which work by stimulating the pancreas to release insulin. Here’s how it fits into the larger market:

Sales Performance

Historical data shows that STARLIX has not been as dominant as other antidiabetic drugs. For instance, between 2012 and 2021, the sales of newer-generation non-insulin drugs like empagliflozin and canagliflozin saw substantial growth, while STARLIX and other traditional drugs experienced relatively stable or declining sales. In Canada, for example, the sales of STARLIX were not as significant compared to other antidiabetic medications like metformin and SGLT-2 inhibitors[4].

Competitive Landscape

The antidiabetic drugs market is highly competitive, with a focus on newer and more effective treatments such as GLP-1 receptor agonists and SGLT2 inhibitors. These drugs have gained significant traction due to their efficacy and the convenience of oral administration, which has impacted the market share of older drugs like STARLIX[1][4].

Financial Trajectory

Revenue Trends

Given the competitive landscape, the revenue from STARLIX has been relatively stable but not as robust as that of newer drugs. The market dynamics favor drugs with better efficacy and fewer side effects, which has led to a decline in the market share of traditional antidiabetic medications.

Cost and Affordability

STARLIX, being an older drug, generally has a lower treatment cost per patient per day compared to newer weight loss and antidiabetic drugs. However, this cost advantage does not necessarily translate into higher sales due to the preference for more effective and modern treatments. In low and middle-income countries, where out-of-pocket expenditure is significant, older drugs like metformin are more commonly used due to their affordability, rather than STARLIX[2].

Distribution and Accessibility

Retail Pharmacies

The distribution of antidiabetic drugs, including STARLIX, is primarily through retail pharmacies, which held the highest market share in 2023. However, the online pharmacy segment is growing rapidly, which could impact the sales channels for STARLIX and other traditional drugs[1].

Clinical Efficacy and Side Effects

Clinical Studies

STARLIX has been studied in various clinical trials, showing its efficacy in lowering blood glucose levels. For example, a 24-week study comparing STARLIX monotherapy with glyburide and metformin showed that STARLIX could effectively reduce HbA1C levels, although it may not be as effective as some newer treatments[5].

Side Effects

Like other antidiabetic drugs, STARLIX has its side effects, which can include hypoglycemia and gastrointestinal symptoms. The management of these side effects is crucial for patient compliance and overall treatment success.

Future Outlook

Market Trends

The future outlook for STARLIX is influenced by broader market trends favoring newer, more effective treatments. The rise of GLP-1 receptor agonists and SGLT2 inhibitors, which offer better glycemic control and additional benefits like weight loss, is likely to continue dominating the market[1][2].

Regulatory Environment

Regulatory approvals and changes in healthcare policies can also impact the market for STARLIX. For instance, recent approvals for newer drugs like Synjardy (empagliflozin and metformin hydrochloride) for pediatric patients indicate a shift towards more advanced treatments[1].

Key Takeaways

• Market Share: STARLIX has a relatively stable but declining market share due to the rise of newer antidiabetic drugs.
• Financial Performance: The revenue from STARLIX is not as robust as that from newer treatments, despite its lower cost.
• Distribution: Retail pharmacies remain the primary distribution channel, but online pharmacies are gaining traction.
• Clinical Efficacy: STARLIX is effective in lowering blood glucose levels but may not match the efficacy of newer treatments.
• Future Outlook: The market is expected to favor newer, more effective treatments, impacting the future sales of STARLIX.

FAQs

1. What is STARLIX used for? STARLIX (nateglinide) is an oral antidiabetic drug used to treat type 2 diabetes by stimulating the pancreas to release insulin.

2. How does STARLIX compare to other antidiabetic drugs? STARLIX is less dominant compared to newer drugs like GLP-1 receptor agonists and SGLT2 inhibitors, which offer better glycemic control and additional benefits.

3. What are the side effects of STARLIX? Common side effects include hypoglycemia and gastrointestinal symptoms.

4. How is STARLIX distributed? STARLIX is primarily distributed through retail pharmacies, although online pharmacies are becoming more significant.

5. What is the future outlook for STARLIX? The future outlook is influenced by market trends favoring newer, more effective treatments, which are likely to continue dominating the market.

Sources

1. Fortune Business Insights: Diabetes Drugs Market Share, Growth | Global Report [2032]
2. AlphaSense: Weight Loss Drugs: What to Know in 2024
3. Morgan Stanley: Scaling Up the Impact of Obesity Drugs
4. Canada.ca: Market Intelligence Report: Antidiabetic Drugs, 2012-2021
5. FDA: STARLIX® (nateglinide) tablets, for oral use