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. Ten 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
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	6,844,008
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-001	Dec 22, 2000	5,463,116
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000	6,559,188
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000	6,878,749
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-001	Dec 22, 2000	6,878,749

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/000335Nateglinide 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/000383Nateglinide 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
Canada	2381992	PROCEDE POUR TRAITER DES TROUBLES METABOLIQUES, EN PARTICULIER LE DIABETE, OU UNE MALADIE OU UN ETAT ASSOCIE AU DIABETE (METHOD OF TREATING METABOLIC DISORDERS, ESPECIALLY DIABETES, OR A DISEASE OR CONDITION ASSOCIATED WITH DIABETES)
South Korea	100343062
Luxembourg	90846
Argentina	028504	COMBINACION, METODO PARA MEJORAR LA APARIENCIA CORPORAL DE UN MAMIFERO, COMPOSICION FARMACEUTICA, USO DE DICHA COMBINACION PARA LA PREPARACION DE UN MEDICAMENTO PARA LA PREVENCION, DEMORA DE PROGRESO, O TRATAMIENTO DE DESORDENES METABOLICOS, Y PAQUETE COMERCIAL
Portugal	965339

Supplementary Protection Certificates for STARLIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
0526171	01C0044	France		PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 20000928
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
0526171	C300063	Netherlands		PRODUCT NAME: NATEGLINIDUM; NAT. REGISTRATION NO/DATE: EU/1/01/174/001EU/1/01/174/002EU/1/01/174/003EU/1/01/174/004EU/1/01/174/005EU/1/01/174/006EU/1/01/174/007EU/1/01/174/008EU/1/01/174/009EU/1/01/174/010EU/1/01/174/011EU/1/01/174/012EU/1/01/174/013EU/1/01/174/014EU/1/01/174/015EU/1/01/174/016EU/1/01/174/017EU/1/01/174/018EU/1/01/174/019EU/1/01/174/020EU/1/01/174/021 2001030403; FIRST REGISTRATION: EU/1/01/174/001EU/1/01/174/002EU/1/01/174/003EU/1/01/174/004EU/1/01/174/005EU/1/01/174/006EU/1/01/174/007EU/1/01/174/008EU/1/01/174/009EU/1/01/174/010EU/1/01/174/011EU/1/01/174/012EU/1/01/174/013EU/1/01/174/014EU/1/01/174/015EU/1/01/174/016EU/1/01/174/017EU/1/01/174/018EU/1/01/174/019EU/1/01/174/

Market Dynamics and Financial Trajectory for Starlix (Nateglinide)

Last updated: February 20, 2026

What is Starlix?

Starlix (generic name: nateglinide) is an oral medication approved for managing postprandial blood glucose levels in type 2 diabetes mellitus patients. It belongs to a class of drugs known as meglitinides that stimulate insulin secretion.

Market Position and Competition

Aspect	Details
Market approval	FDA approved in 2000; EMA approval in 2001
Primary indications	Type 2 diabetes, used as adjunct therapy
Key competitors	Repaglinide, mitiglinide, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists
Market share (2022)	Estimated below 3% of the global oral antidiabetic drugs market
Patent status	U.S. patent expired in 2014, but formulation patents may still hold exclusivity options

Competitive Landscape

Nateglinide faces stiff competition from longer-established drugs like metformin and newer classes such as SGLT2 inhibitors. Its rapid onset and short duration of action give it niche applications but hinder broader market penetration.

Market Drivers

• Rise in prevalence of type 2 diabetes globally
• Increased awareness of postprandial hyperglycemia management
• Patient preference for fast-acting oral options
• Growing adoption of personalized medicine approaches in diabetes treatment

Market Challenges

• Existing treatment options with established efficacy and safety
• Patent expiries leading to generic competition
• Limited differentiation in efficacy compared to newer classes
• Side effect profile, including risk of hypoglycemia

Regulatory and Pricing Environment

Jurisdiction	Status
U.S.	Available as generic after patent expiry; no recent new approvals or formulations
Europe	Similar to U.S., off-patent; market stability depends on generic uptake
Pricing	Competitive, with discounts common for generics; reimbursement varies significantly by country

Financial Trajectory

Revenue Trends

Since patent expiration in 2014, revenue from nateglinide formulations has declined sharply due to generic competition. Reports from major pharmaceutical companies indicate:

• 2013 (pre-expiry): Estimated peak revenue at approximately USD 250 million globally
• 2015 onward: Sharp decline, with revenues dropping below USD 50 million annually
• 2020–2022: Stabilization at low single-digit millions with minimal branded sales

Investment and R&D Outlook

• Limited R&D activity post-patent expiry
• Few pipeline developments or reformulations targeted at re-establishing market presence
• Focus shifted toward newer compounds with better safety profiles and efficacies

Market Forecast (2023–2030)

Scenario	Revenue Estimates	Growth Rate	Notes
Conservative	<$10 million annually	-10% to 0%	Continued generic dominance, limited new initiatives
Moderate	Slight increase if new formulation or combination approved	0% to 5% per year	Possible if a formulation improvement or new delivery method gains approval
Optimistic	Potential revival with new indications or delivery system	5% to 10% through 2030	Requires significant R&D investment and regulatory success

Strategic Outlook

Major pharmaceutical firms have largely disengaged from active development of nateglinide-based drugs. The focus remains on classes with superior safety profiles and broader efficacy, such as SGLT2 inhibitors. Any resurgence would depend on:

• Novel formulations improving compliance
• New combination therapies
• Expanding indications, possibly including prediabetes or metabolic syndrome

Key Takeaways

• Starlix's market has contracted significantly since patent expiry in 2014, with revenues declining from near USD 250 million to minimal levels.
• Competition from newer drug classes and generics limit the growth prospects for nateglinide.
• Future growth hinges on reformulation or combination strategies, which have yet to demonstrate commercial viability.
• No current significant R&D investment in nateglinide or its derivatives is publicly reported.
• The drug's niche remains postprandial glucose control, but alternatives dominate the treatment landscape.

FAQs

1. Will Starlix regain market share in the future?

Unlikely without significant reformulation or new indications, as generic competition dominates and newer therapies outperform in safety and efficacy.

2. Are there ongoing R&D efforts related to nateglinide?

Public disclosures show minimal recent R&D activity; most efforts focus on novel drug classes for diabetes.

3. How does nateglinide compare to other meglitinides?

It has similar efficacy but shorter duration; differences are minor and do not significantly influence market share.

4. What are the main advantages of Starlix?

Rapid onset of action and lower risk of hypoglycemia relative to other insulin secretagogues; limited advantages over newer drug classes.

5. Could regulatory changes impact the market?

Potential policy shifts favoring cost-effective generics could further reduce branded opportunities; conversely, new formulation approvals might create modest growth pathways.

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References

[1] U.S. Food and Drug Administration. (2000). Nateglinide label. Retrieved from https://www.fda.gov

[2] European Medicines Agency. (2001). Summary of product characteristics for Nateglinide. Retrieved from https://www.ema.europa.eu

[3] IQVIA. (2022). Global oral antidiabetic drugs market report.

[4] MarketWatch. (2022). Diabetes drugs market analysis.