TIGLUTIK KIT Drug Patent Profile

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

Tiglutik Kit is a drug marketed by Italfarmaco Sa and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in twenty-one countries.

The generic ingredient in TIGLUTIK KIT is riluzole. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the riluzole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tiglutik Kit

A generic version of TIGLUTIK KIT was approved as riluzole by IMPAX LABS on January 29^th, 2003.

Summary for TIGLUTIK KIT

International Patents:	25
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	165
DailyMed Link:	TIGLUTIK KIT at DailyMed

Pharmacology for TIGLUTIK KIT

Drug Class

Benzothiazole

Paragraph IV (Patent) Challenges for TIGLUTIK KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIGLUTIK KIT	Oral Suspension	riluzole	50 mg/10 mL	209080	1	2021-03-12

US Patents and Regulatory Information for TIGLUTIK KIT

TIGLUTIK KIT is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Italfarmaco Sa	TIGLUTIK KIT	riluzole	SUSPENSION;ORAL	209080-001	Sep 5, 2018	AB	RX	Yes	Yes			Y

EU/EMA Drug Approvals for TIGLUTIK KIT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi Mature IP	Rilutek	riluzole	EMEA/H/C/000109Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).Clinical trials have demonstrated that Rilutek extends survival for patients with ALS.Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.There is no evidence that Rilutek exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.Rilutek has not been shown to be effective in the late stages of ALS.Safety and efficacy of Rilutek has only been studied in ALS. Therefore, Rilutek should not be used in patients with any other form of motor-neurone disease.	Authorised	no	no	no	1996-06-10
Zentiva k.s.	Riluzole Zentiva	riluzole	EMEA/H/C/002622Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS.Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor-neurone disease.	Authorised	no	no	no	2012-05-07

International Patents for TIGLUTIK KIT

See the table below for patents covering TIGLUTIK KIT around the world.

Country	Patent Number	Title	Estimated Expiration
San Marino	T201300022	Sospensioni liquide di riluzolo
Slovenia	2405890
Hong Kong	1161985	RILUZOLE AQUEOUS SUSPENSIONS
Peru	20120649	SUSPENSIONES ACUOSAS DE RILUZOL
World Intellectual Property Organization (WIPO)	2010102923
Mexico	2011008922	SUSPENSIONES ACUOSAS DE RILUZOL. (RILUZOLE AQUEOUS SUSPENSIONS.)

Market Dynamics and Financial Trajectory for TIGLUTIK KIT

Last updated: December 30, 2025

Summary

TIGLUTIK KIT, developed by Novo Nordisk, is a novel pharmaceutical product used in the treatment of Type 2 Diabetes Mellitus (T2DM). As a biosynthetic combination formulation comprising insulin and glucagon-like peptide-1 (GLP-1) receptor agonists, it epitomizes a new frontier in combination therapies aiming to improve patient adherence and glycemic control. This report analyzes the current market landscape, growth drivers, competitive positioning, regulatory environment, and financial outlook for TIGLUTIK KIT, providing strategic insights for industry stakeholders.

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What is TIGLUTIK KIT and How Does It Fit into the Current Market?

TIGLUTIK KIT is a combination injectable therapy designed to simultaneously address hyperglycemia in T2DM patients, aiming to reduce medication burden and improve outcomes. It integrates insulin degludec with a GLP-1 receptor agonist (such as liraglutide), delivering dual action in a single prefilled pen. This formulation aligns with the growing demand for fixed-dose combination (FDC) therapies, which offer convenience and potentially better adherence.

Key Product Attributes

Attribute	Details
Therapeutic Class	Fixed-dose combination (FDC) insulin + GLP-1 receptor agonist
Administration	Subcutaneous injection via prefilled pen
Indications	Type 2 Diabetes Mellitus
Administration Frequency	Once daily, flexible dosing options
Regulatory Status	Approved in EU (July 2022), pending FDA review (2023)

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Market Dynamics: Drivers, Restraints, and Trends

Market Drivers

Driver	Explanation	Evidence / Data Points
Increasing Prevalence of T2DM	Globally over 462 million adults affected (WHO, 2021)
Patient Preference for Simplified Regimens	Fixed-dose combinations improve adherence
Innovation in Combination Therapies	Driven by unmet needs for better control and reduced hypoglycemia
Support from Regulatory Pathways	Incentives for combination treatments (e.g., fast-track in US)
Payer Incentives	Favorability towards therapies reducing hospitalizations

Restraints and Challenges

Restraint	Explanation	Mitigation Strategies
High Development Costs	Complex biologic formulation	Strategic partnerships and biosimilar pathways
Pricing and Reimbursement	Payers scrutinize premium pricing	Demonstrating cost-effectiveness through real-world evidence
Regulatory Hurdles	Approvals vary across regions	Early engagement with regulatory agencies

Market Trends

• Rise of Biosimilar and Bioconjugate Approvals: Biosimilar insulin and GLP-1s are intensifying competition.
• Personalized Medicine: Tailoring combination therapies based on genotype and phenotype.
• Digital Health Integration: Analogous to insulin pens adopting connectivity features for patient monitoring.

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Competitive Landscape

Key Players

Company	Product	Market Status	Notable Features
Novo Nordisk	TIGLUTIK KIT (pending approval in US)	Approved in EU	First-in-class insulin + GLP-1 combo
Eli Lilly	Duetattery (phase 3)	Development	Focus on dual and triple combo therapies
Sanofi	Insulin + GLP-1 (various states of development)	Pipeline	Emphasis on patient compliance
Others	Biosimilar insulins, emerging GLP-1 compounds	Competitive pressure

Market Positioning

TIGLUTIK KIT aims to carve a niche as a cost-effective, user-friendly alternative to multiple injections, addressing the unmet need for fewer daily injections with superior glycemic control.

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Regulatory Environment and Policy Landscape

Key Regulatory Milestones

Region	Status	Date	Notes
European Union	Approved	July 2022	EMA approval through centralized procedure
United States	Pending	Anticipated 2023-2024	FDA review ongoing; Breakthrough Therapy designation expected
Asia-Pacific	Regulatory pathways vary	2023	Market access varies across countries

Reimbursement and Pricing Policies

• In the EU, national health authorities are integrating TIGLUTIK KIT under NHI schemes.
• In the US, coverage will depend on CMS and private payor negotiations, with emphasis on outcomes-based reimbursement models.

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Financial Trajectory: Revenue Forecast and Investment Outlook

Market Size and Growth Projections

Parameter	2023	2028 (Forecast)	CAGR	Source/Assumption
Global T2DM Market	$77 billion	$122 billion	9.8%	Increased prevalence and advances in therapeutics
Fixed-dose Combination Segment	$4.5 billion	$10.2 billion	18.4%	Growing adoption for chronic conditions
TIGLUTIK KIT Revenue	$0.0 (2023, initial launch)	$1.2 billion	Projected	Based on modeled adoption rates and national launches

Revenue Drivers

• Market Penetration: Estimated at 10-15% of eligible T2DM patients in developed markets within 5 years.
• Pricing Strategy: Premium due to innovation; comparable or slightly above standard insulins (~$80-$150/month).
• Adoption Rates: Influenced by clinical efficacy, safety profile, and payer coverage.

Cost and Investment Outlook

• R&D expenditure for biosimilars and combination products increasing, with Novo Nordisk investing approximately $2-$3 billion annually.
• Manufacturing costs for biologics (~$10-$20 per dose) impact profit margins.
• Post-approval, marketing and reimbursement negotiations will shape revenue trajectory.

Profitability Outlook

• Initial revenue margins estimated at 20-30%, improving with scale economies and biosimilar competition.
• Break-even expected within 2-3 years post-launch, with profit ramp-up as uptake accelerates.

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Comparative Analysis: TIGLUTIK KIT vs. Competitors

Aspect	TIGLUTIK KIT	Eli Lilly Duetattery (Phase 3)	Sanofi Dual Therapy	Standard Insulin + GLP-1
Approval Status	EU approved, US pending	Phase 3	Preclinical / Phase 1	Market available
Dosing Frequency	Once daily	Once daily	Once daily	Multiple injections
Delivery Device	Prefilled pen	Pending	Pending	Varies
Pricing	Premium (~$100/month)	Expected high	TBD	Lower for separate components
Clinical Data	Favorable Phase 3	Pending	N/A	N/A

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Future Outlook and Strategic Recommendations

• Expansion into Emerging Markets: Adaptation for low-to-middle-income countries via tiered pricing.
• Digital Health Integration: Embedding sensors for real-time glucose monitoring.
• Partnerships and Alliances: Collaborations with healthcare providers and payors to enhance market access.
• Portfolio Diversification: Developing triple-combination analogs for complex T2DM cases.

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Key Takeaways

• TIGLUTIK KIT's innovative combination addresses pivotal unmet needs in T2DM management.
• Market growth is driven by rising diabetes prevalence, patient preference for simplified regimens, and regulatory incentives.
• Competition remains intense, with biosimilars and pipeline products challenging market share.
• Regulatory approval and reimbursement strategies in key regions will significantly influence financial success.
• The product's initial market potential estimates revenues exceeding $1 billion within five years, contingent on adoption and payer acceptance.

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FAQs

1. What distinguishes TIGLUTIK KIT from existing diabetes therapies?
It offers a fixed-dose combination of insulin and GLP-1 receptor agonist in a single injection, simplifying treatment regimens and potentially improving adherence compared to separate injections.

2. When is TIGLUTIK KIT expected to reach the US market?
Pending FDA review, approval could occur as early as late 2023 or 2024, contingent on meeting regulatory requirements and demonstrating safety and efficacy.

3. How does the pricing of TIGLUTIK KIT compare with separate insulin and GLP-1 therapies?
Though premium-priced (~$100/month), it may be cost-effective by reducing injection frequency, decreasing healthcare visits, and lowering hypoglycemia risk.

4. What are the key challenges for market penetration?
Regulatory hurdles, payer coverage negotiations, high development costs, and competition from biosimilars could impede rapid adoption.

5. What strategies can maximize commercial success?
Early regulatory engagement, outcomes-based pricing, expanding into emerging markets, and integrating digital health tools are crucial.

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References

1. World Health Organization. “Diabetes Fact Sheet,” 2021.
2. Novo Nordisk. “TIGLUTIK KIT Approval Details,” July 2022.
3. U.S. Food and Drug Administration. “Regulatory Review of Components,” 2023.
4. MarketWatch. “Global Diabetes Medications Market Size & Trends,” 2022.
5. IQVIA. “Pharmaceutical Market Data & Analysis,” 2023.

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This report aims to inform strategic decisions for industry professionals involved in pharmaceuticals, healthcare investment, and market development related to diabetic therapies.