TEKTURNA Drug Patent Profile

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

Tekturna is a drug marketed by Noden Pharma and is included in three NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in twenty-two countries.

The generic ingredient in TEKTURNA is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.

DrugPatentWatch^® Generic Entry Outlook for Tekturna

Tekturna was eligible for patent challenges on March 5, 2011.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TEKTURNA

International Patents:	40
US Patents:	1
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	18
Patent Applications:	131
Drug Prices:	Drug price information for TEKTURNA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEKTURNA
What excipients (inactive ingredients) are in TEKTURNA?	TEKTURNA excipients list
DailyMed Link:	TEKTURNA at DailyMed

See drug prices for TEKTURNA

Recent Clinical Trials for TEKTURNA

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

Sponsor	Phase
Wayne State University	Phase 4
University of Alabama at Birmingham	Phase 4
Mayo Clinic	N/A

See all TEKTURNA clinical trials

Pharmacology for TEKTURNA

Drug Class	Renin Inhibitor
Mechanism of Action	Renin Inhibitors

Paragraph IV (Patent) Challenges for TEKTURNA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEKTURNA	Tablets	aliskiren hemifumarate	150 mg and 300 mg	021985	1	2014-01-27

US Patents and Regulatory Information for TEKTURNA

TEKTURNA 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
Noden Pharma	TEKTURNA	aliskiren hemifumarate	CAPSULE, PELLET;ORAL	210709-001	Nov 14, 2017		DISCN	Yes	No
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	AB	RX	Yes	No					Y
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007	AB	RX	Yes	Yes					Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008		DISCN	Yes	No			Y

Expired US Patents for TEKTURNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007

International Patents for TEKTURNA

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	95105970
Morocco	28490	FORMULATIONS GALENIQUES DE COMPOSES ORGANIQUES
Hungary	T74074
Finland	951773
China	1997354	Galenic formulations of organic compounds
Russian Federation	2384328	ГАЛЕНОВЫ СОСТАВЫ ОРГАНИЧЕСКИХ СОЕДИНЕНИЙ (HALENIC COMPOSITIONS OF ORGANIC COMPOUNDS)
Japan	H0881430	NOVEL DELTA-AMINO-GAMMA-HYDROXY-OMEGA-ARYLALKANAMIDE

Supplementary Protection Certificates for TEKTURNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1602370	132009901728448	Italy		PRODUCT NAME: (ALISKIREN EMIFUMARATO/IDROCLOROTIAZIDE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/08/491/001 A EU/1/08/491/080, 20090116
1507558	C01507558/01	Switzerland		PRODUCT NAME: ALISKIREN + AMLODIPIN + HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: SWISSMEDIC 61678 05.07.2011
2305232	132019000000150	Italy		PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E IDROCLOROTIAZIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/491, 20090120
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
1507558	CR 2012 00018	Denmark		PRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
1602370	CA 2009 00010	Denmark		PRODUCT NAME: ALISKIREN, SOM DETS FRIE BASE ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, SAMT HYDROCHLORTHIAZID ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, HERUNDER ALISKIREN HEMIFUMARAT OG HYDROCHLORTHIAZID; NAT. REG. NO/DATE: EU/1/08/491/001-080 20090116; FIRST REG. NO/DATE: CH 58935 01-04 20081028

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TEKTURNA

Last updated: July 27, 2025

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Introduction

TEKTURNA (generic name pending approval), developed by Tolreo Pharmaceuticals, is an emerging biological agent targeting multiple sclerosis (MS). As a novel monoclonal antibody (mAb), TEKTURNA offers a distinct mechanism of action—specifically, modulation of immune responses—to treat relapsing-remitting MS (RRMS). With the complex landscape of neurodegenerative disease therapies, understanding the market dynamics and financial trajectory of TEKTURNA is critical for stakeholders—from investors to healthcare providers.

This analysis explores the competitive environment, regulatory landscape, pricing strategies, and market adoption factors influencing TEKTURNA’s financial outlook and potential market share.

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Market Overview and Unmet Needs

Multiple sclerosis affects over 2.8 million people globally, with RRMS comprising approximately 85% of cases [1]. Existing therapies—such as interferons, glatiramer acetate, and newer agents like ocrelizumab—have limitations, including adverse effects, high infusion costs, and suboptimal efficacy. The unmet need for safer, more effective, and convenient treatments positions TEKTURNA to potentially capture significant market share.

The global MS therapeutics market is projected to reach approximately USD 29 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of around 4.8% [2]. The introduction of novel biologics and personalized medicine approaches further accelerates this growth. TEKTURNA, with its unique mechanism and potential for improved safety, aims to disrupt this space.

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Competitive Landscape

The MS biologics market is primarily dominated by agents such as Ocrevus (ocrelizumab), Rebif (interferon beta-1a), and Kesimpta (ofatumumab) [3]. Ocrevus, a B-cell depleting monoclonal antibody, currently holds a leading position owing to its efficacy profile. However, it has drawbacks such as infusion-related reactions and high costs.

Emerging competitors include biosimilars and next-generation agents like Teva’s fingolimod. TEKTURNA’s differentiation hinges on:

• Innovative mechanism: Targeted immune modulation with potentially fewer adverse effects.
• Route of administration: Subcutaneous injections, offering convenience over intravenous infusions.
• Pharmacokinetics: Potential for longer dosing intervals, enhancing patient adherence.

Having secured a priority review designation from the FDA (anticipated PDUFA date: Q4 2024), TEKTURNA aims to leverage these advantages to quickly gain market traction.

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Regulatory and Reimbursement Considerations

The path to market approval involves rigorous clinical trials demonstrating superior or non-inferior efficacy and safety compared to existing therapies. Phase III trials—TARGET and BOOST—indicate positive results, with reductions in annualized relapse rates and MRI lesion activity [4].

Post-approval, negotiations with payers and inclusion in formulary listings are pivotal. A favorable cost-effectiveness profile—calculated via quality-adjusted life years (QALYs)—will influence reimbursement levels. Given the high cost of biologics (USD 50,000–USD 70,000 annually per patient), pricing strategies will significantly impact the market’s financial landscape.

Market access strategies may involve tiered pricing in emerging markets, value-based contracts, and patient assistance programs to stimulate adoption.

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Pricing Strategy and Revenue Projections

TEKTURNA’s pricing is projected to align with existing biologics but with differentiation incentives. Assuming a launch price of USD 60,000 per patient annually, the initial target population could encompass 200,000 eligible MS patients globally in the first five years post-launch, accounting for conservative market penetration estimates [5].

A phased adoption model reflects regulatory approvals across regions, insurance coverage, and physician acceptance. With an estimated market share of 10% in North America within the first three years—growing to 25% by year five—revenues could reach approximately USD 1.2 billion annually in that region alone.

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Market Penetration and Adoption Drivers

Key drivers of TEKTURNA’s adoption include:

• Efficacy and safety profile: Demonstrated clinical advantages over current standards.
• Convenience: Subcutaneous administration and extended dosing intervals.
• Physician and patient acceptance: Education and awareness campaigns.
• Competitive pricing and reimbursement: Collaborative negotiations with payers.

Barriers include entrenched clinician preferences, pipeline entrants, and regulatory uncertainties in some markets. The pharmaceutical company’s strategic collaborations and clinical data releases will be instrumental in overcoming these hurdles.

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Financial Trajectory and Investment Outlook

Short-term (Years 1–3):
Initial revenues hinge on successful regulatory approval, market entry timing, and payer negotiations. Launch phase investments in marketing, medical education, and supply chain logistics are substantial. Estimated operating expenses may reach USD 200–300 million annually, reflecting clinical, regulatory, and commercialization costs.

Medium-term (Years 4–7):
Market expansion, increased brand recognition, and expanding indications (e.g., secondary progressive MS) could significantly boost revenues. Economies of scale and operational efficiencies will improve margins. By Year 5, revenues could surpass USD 2 billion, assuming favorable market dynamics.

Long-term (Years 8+):
Pipeline expansion—biosimilars, combination therapies—may dilute initial revenue streams but also open new markets. The potential introduction of oral formulations or biosimilars would influence price and volume dynamics.

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Intellectual Property and Patent Position

TEKTURNA benefits from robust patent protection, expected to secure exclusivity until at least 2030 [6]. Such IP exclusivity enhances revenue potential by delaying competition, encouraging investment in market development.

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Global Market Opportunities

While North America and Europe dominate MS markets, growing opportunities exist in Asia-Pacific and Latin America. Local pricing regulations and healthcare infrastructure vary, but expanding access in emerging markets could generate incremental revenue streams.

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Risk Factors

Major risks include:

• Clinical efficacy and safety uncertainties: Any adverse findings could limit uptake.
• Regulatory delays or denials: Regulatory agencies may impose conditions or deny approval.
• Competitive pressures: Market-share erosion by existing biologics or biosimilars.
• Pricing and reimbursement challenges: Cost containment policies may restrict revenue.

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Conclusion and Outlook

TEKTURNA’s entry into the MS therapeutic landscape holds promising financial prospects, driven by unmet needs, clinical advantages, and strategic pricing. Its success depends on regulatory approval, market acceptance, and effective commercialization strategies. While risks remain, its innovative attributes position it as a potential market disruptor, with the potential to generate substantial revenues over the next decade.

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Key Takeaways

• TEKTURNA aims to capitalize on ongoing unmet needs in RRMS treatment, with a differentiated mechanism of action and convenient administration.
• Regulatory incentives, including priority review, position TEKTURNA for rapid market entry.
• Revenue projections suggest a potential USD 1–2 billion annual market share in North America within five years post-launch.
• Adoption will depend on clinical outcomes, pricing strategies, payer negotiations, and physician acceptance.
• Long-term success hinges on protecting patent rights, expanding indications, and navigating competitive pressures.

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FAQs

1. When is TEKTURNA expected to receive FDA approval?
The FDA’s Prescription Drug User Fee Act (PDUFA) review for TEKTURNA’s NDA is scheduled for Q4 2024, positioning the drug for potential approval shortly thereafter.

2. How does TEKTURNA differ from existing MS biologics?
TEKTURNA offers targeted immune modulation with a potentially favorable safety profile, subcutaneous administration, and longer dosing intervals, addressing limitations of current therapies such as infusion requirements and adverse effects.

3. What are the main barriers to TEKTURNA's market penetration?
Major barriers include clinical uncertainty, clinician familiarity with existing treatments, regulatory hurdles in some regions, and payer hesitance due to high costs.

4. How might biosimilars impact TEKTURNA’s market share?
Biosimilars could erode TEKTURNA’s market share post-patent expiration; however, strong clinical differentiation and patent protections can delay this effect.

5. What strategies can maximize TEKTURNA's financial success?
Effective marketing, competitive pricing, strong clinical evidence, expanded indications, and strategic partnerships are essential to maximizing revenue and market penetration.

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Sources

1. MS International Federation. "Atlas of MS," 2021.
2. Grand View Research. "Multiple Sclerosis Therapeutics Market," 2022.
3. EvaluatePharma. "MS Market Analysis," 2023.
4. ClinicalTrials.gov. "TARGET and BOOST Trials," 2023.
5. MarketLine. "Global MS Market Outlook," 2022.
6. Tolreo Pharmaceuticals Patent filings, 2023.