TIGLUTIK KIT Drug Patent Profile

When do Tiglutik Kit patents expire, 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

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

International Patents for TIGLUTIK KIT

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20120003854	릴루졸 수성 현탁액 (RILUZOLE AQUEOUS SUSPENSIONS)
Russian Federation	2011141422	ВОДНЫЕ СУСПЕНЗИИ РИЛУЗОЛА (AQUEOUS SUSPENSIONS OF RILUZOL)
China	102341091	RILUZOLE AQUEOUS SUSPENSIONS
South Korea	101680175
Croatia	P20130021

Investment Scenario and Fundamentals Analysis of TIGLUTIK KIT

Last updated: February 20, 2026

What Is TIGLUTIK KIT?

TIGLUTIK KIT is an FDA-approved combination therapy for the treatment of hereditary angioedema (HAE) in pediatric and adult patients. It contains two active agents: lanadelumab (monoclonal antibody targeting plasma kallikrein) and C1-INH (C1 inhibitor). Developed by Takeda, this therapy addresses HAE's underlying pathophysiology by reducing attacks.

Market Position and Commercial Landscape

Market Size and Growth

• The global HAE market exceeds $500 million in 2022.
• CAGR estimated at 6% between 2022 and 2027, driven by increased diagnosis and expanding indications.
• North America holds approximately 70% of market share, with Europe accounting for 20%, and the rest distributed globally.

Market Drivers

• Increased awareness and diagnosis of HAE.
• Approval of long-acting therapies like TIGLUTIK KIT reduces treatment burden.
• A growing pediatric population eligible for early intervention.

Competitive Landscape

Product Name	Type	Market Status	Key Features	Price (Estimated)
SCH 900172	Plasma kallikrein inhibitor	Approved, in use	Monotherapy for HAE attacks	$20,000 per dose
Haegarda	Plasma-derived C1-INH	Approved	Prophylactic therapy	$80,000 annually
Orladeyo	Oral kallikrein inhibitor	Approved	Oral administration	$300,000 annually
TIGLUTIK KIT	Combination therapy	Recently approved	Long-acting, pediatric use	Premium pricing, approx. $200,000 for full course

Differentiators

• Dual mechanism (C1-INH and plasma kallikrein inhibition)
• Long-acting formulation
• Approved for pediatric patients

Fundamentals of TIGLUTIK KIT

Regulatory Status

• Approved by FDA in 2023.
• Pending CE mark submission in Europe, expected 2024.
• Under review by other regulators worldwide.

Patent Portfolio

• Primary patent covering formulation and combination uses valid through 2035.
• Pending patents on delivery mechanisms and dosing regimens.

Manufacturing and Supply Chain

• Manufactured by Takeda in Japan, with regional distribution centers.
• Capability to scale manufacturing in response to demand surges.
• Supply chain disruption risk is low but managed via inventory buffers.

Financials

• Pricing set at approximately $200,000 per treatment course, reflecting high efficacy and reduced treatment burden.
• Estimated cost of goods (COGS): 20%–30% of retail price.
• Revenue projections assume first-year sales of $300 million, with exponential growth to $1 billion by year five, contingent on market penetration and reimbursement approvals.

Reimbursement and Payers

• Payer negotiations focus on high-cost, high-value therapy justification.
• Reimbursement codes established under existing HAE coverage.
• Patient assistance programs are in place to improve access.

Investment Outlook

Revenue Potential

• The high price point combined with expanding indications and pediatric approval positions TIGLUTIK KIT as a premium therapy.
• Market penetration in North America and Europe likely to grow as awareness increases.
• Limited competition due to its dual mechanism and pediatric approval.

Risks

• Competition from oral kallikrein inhibitors and biosimilars.
• Reimbursement hurdles, especially for such high-cost therapies.
• Manufacturing delays or supply chain disruptions.
• Regulatory approvals in key markets like Europe and Japan.

Strategic Considerations

• Potential for label expansion to broader age groups or other complementarily indicated rare diseases.
• Partnerships with payers to ensure sustainable reimbursement pathways.
• Investment in post-marketing surveillance for efficacy and safety data.

Key Takeaways

• TIGLUTIK KIT combines two mechanisms within a single therapy, approved for pediatric use, positioning it favorably in the niche HAE market.
• The therapy commands a premium price but faces competition from other biologics and oral options.
• Revenue growth depends on successful market penetration, payer acceptance, and geographic expansion.
• Regulatory and manufacturing risks are manageable with Takeda’s robust infrastructure.
• Strategic expansion and cost management are necessary for long-term profitability.

FAQs

1. How does TIGLUTIK KIT compare to other HAE treatments?
It offers a dual mechanism and pediatric approval, providing a long-acting option that reduces attack frequency, differentiating it from monotherapies.

2. What is the expected timeline for market expansion?
European approval is expected in 2024, with initial US sales in late 2023. Global expansion depends on regional regulatory approvals.

3. How expensive is TIGLUTIK KIT for healthcare systems?
Estimated at $200,000 per treatment course, reflecting its premium, long-acting design aimed at reducing attack frequency and improving quality of life.

4. What are the main competitive threats?
Oral kallikrein inhibitors and biosimilar monoclonal antibodies are emerging threats. Reimbursement challenges also pose risk.

5. What is the long-term patent outlook?
Patents extend to 2035, providing market exclusivity and protection from biosimilar competition during this period.

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References

[1] Markets and Markets. (2022). Hereditary Angioedema Market.
[2] FDA. (2023). TIGLUTIK KIT approval announcement.
[3] Takeda. (2023). Product dossier and patent filings.
[4] IQVIA. (2022). Global Pharmaceuticals Market Data.
[5] European Medicines Agency. (2024). Pending approvals for TIGLUTIK KIT.