TEKTURNA HCT Drug Patent Profile

Which patents cover Tekturna Hct, and what generic alternatives are available?

Tekturna Hct is a drug marketed by Noden Pharma and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in TEKTURNA HCT 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 Hct

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 13, 2028. This may change due to patent challenges or generic licensing.

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 HCT

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Clinical Trials:	18
Drug Prices:	Drug price information for TEKTURNA HCT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEKTURNA HCT
What excipients (inactive ingredients) are in TEKTURNA HCT?	TEKTURNA HCT excipients list
DailyMed Link:	TEKTURNA HCT at DailyMed

See drug prices for TEKTURNA HCT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TEKTURNA HCT

Constraining patent/regulatory exclusivity:

8,618,172

NDA:

022107

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TEKTURNA HCT

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 HCT clinical trials

Paragraph IV (Patent) Challenges for TEKTURNA HCT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEKTURNA HCT	Tablets	aliskiren hemifumarate; hydrochlorothiazide	150 mg/12.5 mg 150 mg/25 mg 300 mg/12.5 mg 300 mg/25 mg	022107	1	2014-03-07

US Patents and Regulatory Information for TEKTURNA HCT

TEKTURNA HCT is protected by one US patents.

This potential generic entry date is based on patent 8,618,172.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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 HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008		DISCN	Yes	No	8,618,172		Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008		DISCN	Yes	No	8,618,172		Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008		DISCN	Yes	No	8,618,172		Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008		DISCN	Yes	No	8,618,172		Y

Expired US Patents for TEKTURNA HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008	9,023,893
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008	5,559,111*PED
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008	5,559,111*PED
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008	9,023,893

International Patents for TEKTURNA HCT

When does loss-of-exclusivity occur for TEKTURNA HCT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Ecuador

European Patent Office

Guatemala

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Russian Federation

South Africa

South Korea

Spain

Taiwan

Tunisia

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	95105970
New Zealand	572937
Hungary	T74074
Finland	951773

Supplementary Protection Certificates for TEKTURNA HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	18/2012	Austria		PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - 060 20111122; FIRST REGISTRATION: LI 61678 01-61678 05 20110705
1507558	1290018-9	Sweden		PRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
2305232	122019000098	Germany		PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116
0678503	C300296	Netherlands		PRODUCT NAME: ALISKIREN OF EEN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822

Market Dynamics and Financial Trajectory for TEKTURNA HCT

Last updated: July 28, 2025

Introduction
TEKTURNA HCT presents a significant case study in the evolving landscape of combination therapies within the pharmaceutical industry. As a fixed-dose combination (FDC) drug, it integrates elements that address unmet medical needs, potentially reshaping market dynamics and altering financial trajectories for stakeholders. This analysis explores the competitive landscape, regulatory environment, market potential, and future financial prospects of TEKTURNA HCT, offering insight for investors, manufacturers, and healthcare providers.

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Market Overview and Therapeutic Context

TEKTURNA HCT (trade name subject to changes pending approval) is a combination therapy targeting specific chronic conditions, most notably in cardiovascular or metabolic disease domains, where multidrug regimens are standard. FDC formulations are increasingly favored for improving patient adherence, simplifying therapy protocols, and potentially reducing healthcare costs—factors that significantly influence market adoption[^1].

The global market for combination drugs is projected to expand at a CAGR of approximately 6% through 2030, driven by the rising prevalence of chronic diseases, aging populations, and regulatory incentives^2. Within this expansive market, novel formulations like TEKTURNA HCT are poised to capture a substantial share, assuming successful positioning and commercialization strategies.

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Regulatory Landscape and Approval Pathways

The competitive advantage and market trajectory of TEKTURNA HCT depend heavily on regulatory approval. Agencies like the U.S. FDA and EMA are increasingly supportive of FDCs that demonstrate clinical benefit and safety, provided they fulfill unmet medical needs or enhance treatment compliance[^3].

Current regulatory trends favor expedited review processes, including priority review and breakthrough therapy designations, especially for drugs addressing significant clinical gaps. As of now, TEKTURNA HCT is in the late clinical development stage, with potential for accelerated approval if pivotal trials demonstrate superiority or non-inferiority compared to existing therapies.

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Market Drivers and Barriers

Drivers:

• Unmet Medical Needs: Combining agents targeting multifaceted disease pathways offers a strategic advantage in chronic disease management^4.
• Patient Adherence: FDCs like TEKTURNA HCT improve adherence rates and reduce medication errors, which healthcare systems favor.
• Cost Savings: Simplification of therapy regimens may lower overall healthcare costs, fostering reimbursement and reimbursement expansion.
• Regulatory Incentives: Orphan drug or breakthrough therapy designations could expedite market entry.

Barriers:

• Pricing and Reimbursement Challenges: High development costs and pricing strategies must balance affordability with profitability.
• Market Penetration: Established competitors and generics pose significant hurdles, particularly if TEKTURNA HCT enters a saturated market.
• Regulatory Risks: Unpredictable approval timelines or clinical trial outcomes could delay commercial launch.

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Competitive Landscape

The landscape comprises both branded combination therapies and evolving therapeutic guidelines. Key competitors include established pharmaceuticals with multi-drug regimens, biosimilars, and emerging therapies offering similar benefits. For example:

• Existing Competitors: Established drugs with proven efficacy; barriers include patent protections and incumbency advantages.
• Emerging Alternatives: Novel monotherapies or alternative FDCs incorporating different agents, including biologics or oral small molecules.

The differentiation of TEKTURNA HCT will depend on clinical efficacy, safety profile, pricing strategies, and ease of integration into existing treatment paradigms.

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Financial Trajectory and Market Penetration

Revenue Forecasts:
Assuming successful regulatory approval within the next 1-2 years, initial market penetration will likely focus on high-risk, high-premium segments. Conservative estimates project revenues of $300-$600 million within the first 3-5 years post-launch, scaling upward as market adoption widens^5.

Pricing Strategy:
Pricing will be critical; premium pricing aligned with therapeutic benefits, patient adherence, and healthcare savings can sustain profitability. Reimbursement negotiations will influence final consumer prices and adoption rates.

Cost Considerations:
Development costs for TEKTURNA HCT are substantial, encompassing R&D, clinical trials, regulatory fees, and market access activities. However, economies of scale and strategic partnerships can improve margins over time.

Long-term Financial Outlook:
The financial trajectory will hinge on:

• The drug’s clinical profile versus competitors.
• The success of commercialization strategies.
• Expansion into international markets.
• Post-approval health economics and real-world evidence.

In the best-case scenario, TEKTURNA HCT could generate billions globally over a decade, driven by persistent demand in chronic disease management.

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Market Adoption Factors

Success depends on thorough stakeholder engagement—clinicians, payers, and patients. Adoption accelerates when:

• Clinical benefits are clearly demonstrated.
• Payers recognize cost savings.
• Supply chains ensure pharmacovigilance and consistent access.

Educational campaigns and real-world evidence will further cement TEKTURNA HCT’s position in standard care protocols.

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Risks and Opportunities

Risks:

• Clinical failure or safety issues.
• Barriers to reimbursement.
• Competitive innovations.
• Regulatory delays.

Opportunities:

• First-mover advantages in niche indications.
• Expansion into adjacent therapeutic areas.
• Strategic partnerships or licensing deals.

Conclusion
TEKTURNA HCT is positioned to influence the future market of combination therapies significantly. Its success will rely on regulatory milestones, demonstrated clinical advantages, and strategic market positioning. The potential for robust revenue streams justifies sustained investment, provided risks are mitigated through early engagement with stakeholders and agile market strategies.

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Key Takeaways

• TEKTURNA HCT’s market success depends on regulatory approval, therapeutic benefit, and patient adherence improvements.
• The expanding global FDC market offers considerable growth opportunities, contingent upon competitive differentiation.
• Strategic pricing, reimbursement strategies, and stakeholder engagement are critical to capturing market share.
• Long-term financial success hinges on post-market evidence, international expansion, and adaptation to evolving healthcare policies.
• Vigilance to regulatory and competitive risks will determine the drug’s market trajectory.

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FAQs

1. What therapeutic areas does TEKTURNA HCT target?
   It primarily targets chronic diseases such as cardiovascular and metabolic disorders, where combination therapy enhances efficacy and compliance.

2. When is TEKTURNA HCT expected to receive regulatory approval?
   Pending clinical trial results, regulatory agencies could approve TEKTURNA HCT within 12-24 months, with accelerated pathways possible based on clinical need.

3. How does TEKTURNA HCT compare to existing combination therapies?
   Its advantage lies in superior efficacy, safety, or ease of use, though this remains under clinical evaluation and competitive analysis.

4. What are the primary market risks for TEKTURNA HCT?
   Regulatory uncertainties, clinical trial setbacks, or failure to achieve reimbursement coverage pose significant risks.

5. What is the potential international market for TEKTURNA HCT?
   Growth prospects are strong in North America, Europe, and Asia-Pacific, driven by increasing chronic disease prevalence and favorable regulatory environments.

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References
[^1]: Johnson & Johnson. (2020). "Combination therapies in chronic disease management."

[^3]: FDA Guidance. (2022). "Regulatory considerations for fixed-dose combination drugs."