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 is one drug master file entry for this compound. Nine 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:	5,667
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

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	Withdrawn	no	no	no	2001-04-03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
Austria	149483
Brazil	1100807
Canada	2114678	CRISTAUX DE N-(TRANS-4-ISOPROPYLCYCLOHEXYLCARBONYL)- D-PHENYLALANINE ET METHODES POUR LES PREPARER (CRYSTALS OF N-(TRANS-4-ISOPROPYLCYCLOHEXYLCARBONYL)- D-PHENYLALANINE AND METHODS FOR PREPARING THEM)

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	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/

Last updated: July 29, 2026

STARLIX (nateglinide) market dynamics and financial trajectory: revenue drivers, demand outlook, and exclusivity pressure

STARLIX (nateglinide) is a branded, first-in-class-within-its-subclass oral insulin secretagogue for type 2 diabetes, positioned as a mealtime glucose-control agent. Market dynamics are dominated by generic penetration, limited payer preference versus newer classes (DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors), and shrinking formulary share as clinicians shift to outcomes-backed therapies. Financial trajectory is therefore structurally constrained: branded revenues decline as generics capture most US and ex-US demand, with only continued niche use sustaining residual sales.

Core market reality: STARLIX faces the economics of an older diabetes molecule with widespread generic availability; the long-term revenue path is primarily a function of remaining on-formulary niches and competitive substitution by newer glucose-lowering drug classes rather than incremental clinical expansion.

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Is STARLIX (nateglinide) a growth drug or a declining franchise?

Answer: STARLIX is a declining franchise in most markets due to generic competition and class shift toward higher-evidence, higher-utilization diabetes platforms.

What market forces push STARLIX down

• Generic displacement: Nateglinide is available as generics in major markets, compressing branded pricing and reducing volume share.
• Class competition: Diabetes management has moved toward agents with demonstrated cardiovascular, renal, or weight benefits (SGLT2 inhibitors, GLP-1 RAs). These classes can displace older insulin secretagogues even when A1c lowering efficacy is broadly comparable.
• Clinical workflow changes: For many patients, clinicians prefer simpler regimens and once-daily options, reducing uptake of short-acting mealtime secretagogues taken around meals.
• Payer strategy: Formularies increasingly optimize for drug-class value, and older agents with fewer outcomes signals tend to lose preferred status.

Where STARLIX can hold share

• Niche meal-time control: Patients needing targeted post-prandial control or those who do not tolerate other agents.
• Line-of-therapy effects: In some settings, secretagogues still remain in the practical toolkit for cost-sensitive patients.
• Regional formulary inertia: Some formularies retain older options for long periods even as prescriber behavior evolves.

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What is the revenue model for STARLIX (nateglinide) in the US and Europe?

Answer: The revenue model is largely volume-and-price dependent under post-patent conditions, with branded pricing pressure and limited ability to offset with new indications or formulation differentiation.

US commercial structure

• STARLIX is an older marketed drug; branded sales typically persist only where the brand retains limited payer and patient pull.
• Under generic competition, branded manufacturers usually rely on:
  • remaining specialist and community prescriber use,
  • plan-level contracting exceptions,
  • rebates that can keep effective net price above generic benchmarks, though typically at margin dilution.

Europe commercial structure

• Market dynamics are driven by:
  • national reimbursement policies,
  • pharmacist substitution rules,
  • incumbent generic entry speed in each country,
  • budget impact assessment practices (relative to GLP-1 RA and SGLT2 inhibitor coverage).

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How does generic availability affect STARLIX financial trajectory?

Answer: Generic availability is the dominant driver of branded erosion and net revenue compression.

Mechanisms of financial impact

• Price compression: Brand effective net prices fall as payers establish generic tiers.
• Volume shift: Patients and prescribers move to generics via substitution or lower copays.
• Channel leverage: Large pharmacy benefit structures encourage generic use.
• Reduced marketing ROI: With shrinking branded demand, commercial spend-to-revenue ratio tends to worsen unless the brand can defend niche use.

Net effect

• Expected trajectory: sustained decline unless there is a structural reason for continued brand use (rare in highly substitutable, older molecules).

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What competitive landscape surrounds STARLIX (nateglinide) in type 2 diabetes?

Answer: STARLIX competes against:

• DPP-4 inhibitors (A1c lowering with tolerability advantages),
• SGLT2 inhibitors (A1c plus renal and cardiovascular benefit),
• GLP-1 receptor agonists (weight loss and outcomes benefit),
• other insulin secretagogues where still preferred,
• metformin-based regimens as background standard.

Class substitution impact

• Secretion-based therapy displacement: Newer classes can reduce reliance on short-acting secretagogues.
• Outcomes-driven prescribing: Many prescribers treat diabetes with cardiometabolic risk stratification, favoring agents with benefit beyond glycemic control.

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What payer and formulary dynamics determine STARLIX uptake?

Answer: Payer preference flows to drug classes with favorable budget impact versus clinical benefit, and then to preferred formulary tiers, leaving STARLIX with limited preferred positioning.

High-intent payer levers

• Formulary tiering: STARLIX typically cannot compete with generics on price if generics are available for nateglinide.
• Utilization management: Where newer agents dominate, plans require step therapy or prior authorization for non-preferred options, including older secretagogues.
• Outcomes evidence: Even for glycemic alternatives, plans increasingly align with evidence-based benefits.

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When does STARLIX lose exclusivity, and how does that map to commercialization timing?

Answer: STARLIX has long since entered the post-exclusivity environment in major markets; remaining branded demand is therefore residual rather than structurally protected.

How exclusivity history typically translates into the revenue curve

• Pre-exclusivity: Higher branded share before generic entry.
• At generic entry: Step-change decline in price and volume.
• Post-generic stabilization: Lower plateau level based on niche use, but limited upside.

(No US Orange Book, FDA exclusivity catalog, or patent-expiration dataset is included in the provided source material here, so this section cannot provide date-specific exclusivity timelines.)

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What filings and FDA status risks exist for STARLIX (nateglinide) generics and biosimilars?

Answer: STARLIX is a small-molecule product, so biosimilar risks are not applicable. The relevant risk set is generic ANDA competition and labeling/therapeutic equivalence in FDA-reviewed products.

Regulatory structure for STARLIX

• Generic entry depends on ANDA approvals and bioequivalence.
• Any branded remaining lifecycle value depends on:
  • product-specific labeling distinctions that are not available in generics (rare for older molecules),
  • or any later-introduced formulation strengths (not evidenced here in the provided material).

(No FDA product listing, Orange Book patent list, ANDA status, or label-change timeline is provided in the prompt, so this section does not include document-level entry or litigation triggers.)

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What patent estate protects STARLIX (nateglinide), and how strong is it commercially?

Answer: The commercial strength of STARLIX’s patent estate is low under typical post-patent conditions, because the molecule is mature and generic availability is widespread.

Commercial interpretation

• Even if patents exist around formulation, method-of-use, or crystalline forms, small-molecule generic competition generally erodes branded revenues quickly once the principal composition-of-matter barrier falls.
• For revenue trajectory, the key question is not whether any patents remain, but whether they prevent generic substitution. That market impact is usually limited for older secretagogues.

(No patent list or expiry dataset is provided in the prompt, so patent numbers, jurisdictions, and expiration dates cannot be stated.)

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How does STARLIX financial performance compare with newer diabetes drugs?

Answer: STARLIX materially underperforms newer diabetes franchises because it lacks:

• modern outcomes-linked growth narrative,
• protected pricing power against class leaders,
• high-utility once-daily or weight-loss/outcomes-positioned regimens.

Competitive valuation framing

• Newer diabetes drugs benefit from large addressable populations, persistent growth cycles driven by outcomes and guideline updates, and often protected blockbuster economics.
• STARLIX competes in a residual pocket of older secretagogue preference with generic price anchors.

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What are the most likely generic launch scenarios for STARLIX (nateglinide)?

Answer: Under standard small-molecule dynamics, launch scenarios involve additional generic products rather than a branded “win” in exclusivity.

Scenario set

• Scenario A: additional ANDA entrants
  • drives further margin compression for brand and for any remaining branded contracts.
• Scenario B: substitution shifts at the pharmacy
  • accelerates volume migration to lower-cost products.
• Scenario C: package/label equivalence normalization
  • reduces any last barrier to switching.

(No current ANDA pipeline or Orange Book “risk” analysis was provided, so these remain scenario patterns rather than document-tethered predictions.)

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What litigation or settlements affect STARLIX market dynamics?

Answer: Litigation can affect short-term switching velocity when it delays generic entry or supports brand settlement. In mature, widely genericized small molecules like nateglinide, the longer-run effect tends to be limited to the timing window around generic challenges.

(No STARLIX-specific litigation docket references or settlement terms were included in the prompt, so this section contains no case-level facts.)

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What manufacturing and IP barriers could slow STARLIX genericization?

Answer: For older small molecules, barriers typically reduce to:

• formulation manufacturing tolerances,
• bioequivalence execution,
• and any remaining product-specific IP.

What usually does not apply

• Biosimilar manufacturing constraints do not apply because STARLIX is not a biologic.
• Large device or delivery-platform constraints are not relevant.

(No STARLIX formulation/manufacturing IP documentation is provided in the prompt.)

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Key takeaways on STARLIX market dynamics and financial trajectory

• STARLIX is a post-generic, residual-niche brand in type 2 diabetes, with financial trajectory dominated by generic price-and-volume displacement.
• The most material demand headwinds are payer formulary tiering, step therapy, and class substitution toward DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors.
• The product’s long-term growth probability is low; its revenue outlook depends mainly on persistence of niche mealtime glucose-control use and how payers maintain coverage despite generic anchors.
• Patent and exclusivity effects are unlikely to be the primary driver now, given STARLIX’s mature market status, absent specific late-cycle IP barriers.

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FAQs

1) Is STARLIX (nateglinide) still prescribed today, and where is it used most?

It is typically used in niche clinical contexts for mealtime post-prandial control where newer agents are not used or are not tolerated, with greatest persistence where formulary inertia and cost constraints allow continued secretagogue prescribing.

2) Does STARLIX have any advantage over DPP-4 inhibitors or SGLT2 inhibitors?

Its commercial positioning is mainly post-prandial glucose control around meals. Class competitors often win formulary share through broader tolerability, dosing convenience, or outcomes-linked benefits.

3) What happens to STARLIX revenue if generic prices fall further?

Branded STARLIX net revenue generally declines because branded effective pricing and volume both erode under stronger price competition, with limited ability to defend share.

4) Are there biosimilar threats to STARLIX?

No. STARLIX is a small molecule, so biosimilar pathways do not apply.

5) What is the main regulatory pathway for new competition to STARLIX?

Additional generic products via ANDA bioequivalence approvals, which intensify price competition rather than create new market expansion.

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References

1. (No source documents were provided in the prompt containing FDA Orange Book listings, patent expiry dates, sales figures, or payer/reimbursement data for STARLIX. Without cited source material, no compliant reference list can be generated.)