TEKTURNA HCT Drug Patent Profile

When do Tekturna Hct patents expire, and when can generic versions of Tekturna Hct launch?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEKTURNA HCT

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.

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

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:

Chile

Malaysia

Taiwan

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
Austria	183997
Australia	1642095
Australia	1642195
Australia	1642395

Supplementary Protection Certificates for TEKTURNA HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0678503	C300386	Netherlands		PRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028
0678503	07C0055	France		PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
0678503	C00678503/01	Switzerland		PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007

TEKTURNA HCT (aliskiren + hydrochlorothiazide) investment scenario and patent/regulatory fundamentals: exclusivity timeline, generic risk, and licensing implications

Last updated: July 18, 2026

TEKTURNA HCT (aliskiren hydrochloride + hydrochlorothiazide) is a fixed-dose combination (FDC) antihypertensive. The investment profile is driven by (1) patent and exclusivity clocks tied to aliskiren and HCT components, (2) FDA regulatory status and market access pathway outcomes for generics, and (3) litigation and Orange Book entry complexity that can delay but rarely eliminate FDC generic entry once key exclusivities and patents expire. Current fundamentals skew toward limited long-term upside for new commercialization investment because the platform economics are constrained by mature competitive entry and a regulatory backdrop that has historically limited broader aliskiren clinical use.

What patents protect TEKTURNA HCT (aliskiren HCT) in the US and how strong is the estate?

Key investment point: for an FDC like TEKTURNA HCT, the relevant IP estate is usually a blend of (a) drug substance/formulation patents covering aliskiren, (b) combination/FDC patents covering aliskiren + HCT in specific dosage forms/ratios, and (c) use patents that may narrow covered patient populations or dosing regimens. The strength and remaining life of those subsets determine whether generic entry is delayed by Orange Book-listed IP.

Core patent estate categories that typically drive TEKTURNA HCT generic delay

• Composition-of-matter coverage on aliskiren (active ingredient)
• Formulation patents on solid oral dosage design (tablets, coatings, release characteristics)
• Combination patents specific to aliskiren + hydrochlorothiazide fixed dosing
• Method-of-use claims (if present) tied to hypertension treatment claims

What investors should model

• Whether Orange Book listings for TEKTURNA HCT are dominated by expiring aliskiren substance/formulation patents versus combination-specific patents.
• Whether any later-expiring patents cover the specific FDC ratio and tablet manufacture.
• Whether multiple independent patent barriers exist (high delay probability) or a single dominant barrier (event-driven risk).

How many patents cover TEKTURNA HCT and which assignees typically hold them?

Without the TEKTURNA HCT-specific Orange Book listing set, the number of patents and their assignees cannot be stated precisely here. The correct investment workflow is to extract:

• Listed patents for the drug product code and strength(s)
• Patent numbers, assignees, expiration dates, and whether they are “NCE,” “method of use,” or “formulation” type
• Exclusivity codes (marketing exclusivity and any pediatric exclusivity affecting timing)

This is the single most important diligence step for quantifying generic launch risk and settlement likelihood in Paragraph IV contexts.

When does TEKTURNA HCT lose exclusivity in the US (Hatch-Waxman) and what is the expiration timeline?

Key investment point: FDC products lose commercial exclusivity once (1) regulatory exclusivity expires and (2) all Orange Book-listed patents tied to that drug product expire or are cleared via litigation/settlement.

Timelines investors should calculate

• Earliest Orange Book patent expiration for TEKTURNA HCT drug product
• Additional delays from pediatric exclusivity or terminal disclaimers
• Any remaining exclusivity triggered by NDA amendments or new dosing strengths
• Expected generic approval windows for ANDA filing and launch timing

Does TEKTURNA HCT have data exclusivity and how long does it last?

TEKTURNA HCT’s exclusivity depends on the underlying NDA approval year and any supplemental NDA (sNDA) for the specific strengths or formulation. The exclusivity structure is typically:

• 5 years new chemical entity exclusivity (if applicable to the active ingredient)
• 3 years exclusivity for changes under 505(b)(2) or certain sNDAs (if applicable)
• Patent term protections that extend effective market exclusivity

A precise exclusivity schedule requires the FDA exclusivity and Orange Book record for the specific TEKTURNA HCT NDA/supplement(s).

What generic entry risks exist for TEKTURNA HCT (ANDAs, Paragraph IV, and settlement dynamics)?

Key investment point: combination products experience faster competitive erosion when either (a) FDC-specific patents are limited, or (b) litigation settlements clear multiple barriers at once. Conversely, if combination formulation patents and method-of-use claims persist, Paragraph IV challenges can drive multi-year delays.

Generic entry risk drivers

• Remaining life of FDC-specific claims versus aliskiren-only claims
• Whether patents are product-specific (tablet strength/ratio) or platform claims (aliskiren)
• Whether “carve-out” strategies can bypass asserted claims (design-around)
• Number of qualified ANDA challengers and whether early entrants receive first-launch exclusivity

What is the Paragraph IV litigation landscape for TEKTURNA HCT?

An investment-grade analysis requires:

• ANDA filer names
• Listed patents asserted in complaints
• Court docket status, trial dates, and settlement announcements
• Stipulated launch dates or agreed “skinny label” timelines

Without the TEKTURNA HCT litigation dataset, the litigation landscape cannot be stated accurately here.

What is the Orange Book status of TEKTURNA HCT (NDA number, drug product codes, and listed patents)?

Key investment point: Orange Book listings define the legal “firewall” for generic competition. The investment model depends on drug product code-specific patent sets.

Orange Book items to extract and quantify

• NDA holder(s)
• Drug product codes for TEKTURNA HCT strengths
• Listed patents with expiration dates
• Exclusivity periods tied to the NDA
• Whether the patent set includes manufacturing and formulation claims that can be bypassed

A complete Orange Book status table cannot be produced here without the TEKTURNA HCT Orange Book listing records.

How does TEKTURNA HCT compare with other aliskiren or ARB/HCT combinations on IP barriers and competitive exposure?

Key investment point: commercial erosion is usually product class-driven, not just IP-driven. TEKTURNA HCT competes in the hypertension FDC market where ARB/HCT and ACE/HCT combinations have deep generic penetration.

Competitive categories

• ARB + HCT FDCs (market structure favors generics once patents expire)
• ACE inhibitor + HCT FDCs (similarly generic-dominant)
• Direct renin inhibitor combinations (aliskiren-based; fewer players)

What matters for investment returns

• Net revenue and share trend for aliskiren-based FDCs versus ARB/HCT generics
• Pricing power after generic entry in the same strength(s)
• Manufacturer and wholesaler contract dynamics that can accelerate substitution

What formulations are protected by TEKTURNA HCT patents (tablet, dosing ratio, and manufacturing method)?

Key investment point: generic designers typically need either bioequivalence plus permissible formulation design or a full carve-out from protected formulation claims. If TEKTURNA HCT has narrow manufacturing-method claims, generic delay risk is lower.

Formulation/IP hotspots to check

• Tablet composition and excipient design
• Release profile (immediate vs controlled release)
• Fixed combination ratio constraints
• Coating or stability-related formulation claims
• Manufacturing method claims that can block simple substitution

What FDA regulatory status does TEKTURNA HCT have (approval pathway, labeling, and safety signals affecting demand)?

Key investment point: investment fundamentals are shaped by label scope. Even if IP barriers delay generics, demand can be constrained by contraindications and limitations.

Regulatory demand-impact levers

• Indicated patient populations and any contraindications (especially those that reduce eligible use)
• Safety communications that affect prescriber behavior
• Switching to alternate therapy classes (ARB/HCT, ACEi/HCT, CCB/HCT FDCs)

Does TEKTURNA HCT face labeling limitations that reduce addressable market?

Historically, the aliskiren class has faced labeling restrictions tied to safety in certain high-risk populations, which can pressure long-term demand. Investment modeling should treat those limitations as permanent competitive headwinds unless label expansion occurs.

Which companies produce TEKTURNA HCT and what commercial exposure does that create for settlement or licensing deals?

Key investment point: combination antihypertensive markets often settle through licensing or by allowing early approval with launch timing restrictions. The commercial exposure is driven by:

• Existing brand market share
• Generic entrants’ timing and willingness to settle
• Payer formulary behavior that accelerates substitution

A precise maker/entrant map requires the FDA label manufacturer(s) and the ANDA applicant list for TEKTURNA HCT.

What patent litigation affects TEKTURNA HCT market timing (court outcomes, injunction risk, and launch triggers)?

Key investment point: the practical schedule is determined by:

• Whether courts grant injunctive relief or only monetary outcomes
• Whether settlements include “trigger dates” tied to patent expiry
• Whether “carve-out” labels permit immediate launch

A court-level timeline for TEKTURNA HCT cannot be reliably provided here without the asserted-patent record and docket outcomes.

What generic entry scenarios should investors model for TEKTURNA HCT (best case, base case, worst case)?

Key investment point: for FDC antihypertensives, scenario modeling should reflect that even when IP delays occur, erosion is typically swift after clearance.

Scenario framework

• Best case: early clearance, multiple patent barriers fall quickly; generic entry in target strengths; rapid price compression
• Base case: limited delay due to one dominant patent barrier; fewer entrants; partial substitution and slower erosion
• Worst case: combination formulation or method-of-use claims sustain longer litigation; entry delayed but ultimately inevitable as platform aliskiren claims expire

Revenue exposure: how much does TEKTURNA HCT face from generic substitution risk?

Key investment point: revenue exposure is the product of (a) the portion of brand sales in affected strengths, (b) elasticity of substitution among prescribers, and (c) payer tier placement.

To quantify exposure, investors need:

• Recent TEKTURNA HCT brand sales by strength
• Generic availability in those strengths (if any)
• Net price trajectory and rebate compression

A quantitative exposure model cannot be produced here without TEKTURNA HCT sales and competitor entry data.

Key Takeaways

• TEKTURNA HCT investment fundamentals hinge on the Orange Book-listed patent set for the specific drug product codes and strengths, plus any exclusivity periods tied to the underlying NDA/supplement.
• The generic substitution risk for hypertension FDCs is typically high once core barriers expire, with settlement and Paragraph IV timing acting mainly as a delay lever.
• Regulatory label scope and safety constraints that limit aliskiren use create structural demand headwinds that can cap brand durability even when IP lasts.

FAQs

1. How do Orange Book drug product codes change the patent barrier for TEKTURNA HCT strengths?
2. What is the typical settlement structure for hypertension FDC Paragraph IV cases (carve-out labels vs launch dates)?
3. What formulation design-around strategies can reduce infringement risk for FDC tablet patents?
4. How do aliskiren label restrictions affect payer formulary placement compared with ARB/HCT products?
5. What does a generic launch model assume about time-to-substitution after ANDA approval for FDC antihypertensives?

References

1. FDA. Approved Drug Products and Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration.
2. FDA. Drug Label Information for TEKTURNA HCT (aliskiren/hydrochlorothiazide). U.S. Food and Drug Administration.
3. U.S. Patent and Trademark Office. Patent assignments and publication records for aliskiren and related formulations.