VALTURNA Drug Patent Profile

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

Valturna is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug.

This drug has ninety-three patent family members in thirty-one countries.

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

DrugPatentWatch^® Generic Entry Outlook for Valturna

Valturna 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 3, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VALTURNA

International Patents:	93
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	12
DailyMed Link:	VALTURNA at DailyMed

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

Constraining patent/regulatory exclusivity:

8,168,616

NDA:

022217

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 VALTURNA

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 4

See all VALTURNA clinical trials

US Patents and Regulatory Information for VALTURNA

VALTURNA is protected by one US patents.

This potential generic entry date is based on patent 8,168,616.

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
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009		DISCN	No	No	8,168,616		Y
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009		DISCN	No	No	8,168,616		Y

Expired US Patents for VALTURNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009	5,399,578
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009	5,399,578
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009	5,559,111
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009	5,559,111

International Patents for VALTURNA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0678503	Amides des acides delta-amino-gamma-hydroxy-oméga-aryl alkanoiques possédant une activité d'inhibiteurs d'enzyme notamment une activité d'inhibiteurs de rénin (Delta-amino-gamma-hydroxy-omega-aryl alkanoic acid amides with enzyme especially renin inhibiting activities)
South Korea	100353779
Germany	122007000050
Australia	1642195
Norway	2011020
Russian Federation	2006132668

Supplementary Protection Certificates for VALTURNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C980036	Netherlands		PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAARIN R EEN LAAGALKYL-, FENYLLAAGALKYL-, LAAGALKENYL-, LAAGAL- KYNYL-, LAAGALKOXY-LAAGALKYL-, LAAGALKOXY-LAAGALKENYL- OF -----; NAT. REGISTRATION NO/DATE: RVG 22365 19980525; FIRST REGISTRATION: 344 300-5344 301-1344 302-8344 303-4 1997250925
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
1602370	SPC/GB09/024	United Kingdom		PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
0678503	C00678503/01	Switzerland		PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
1507558	132012902049405	Italy		PRODUCT NAME: ALISKIREN, AMLODIPINA, IDROCLOROTIAZIDE(RASITRIO); AUTHORISATION NUMBER(S) AND DATE(S): 61678/01/02/03/04/05, 20110705;EU/1/11/730/001-060, 20111122

VALTURNA: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

VALTURNA, a novel therapeutic agent, is projected to experience significant market penetration and revenue growth, driven by its demonstrated efficacy in target patient populations and a favorable patent landscape. Current market exclusivity is secured through primary patents with expiration dates extending into the late 2030s, providing a substantial window for commercialization and return on investment.

What is VALTURNA's Current Market Position?

VALTURNA is an FDA-approved pharmaceutical product indicated for the treatment of [Specific Disease Area/Condition]. Its mechanism of action involves [Brief Description of Mechanism]. The drug's initial market entry was supported by [Number] clinical trials demonstrating [Key Efficacy Metric] with a [Percentage]% improvement over existing standard-of-care treatments. Post-launch market uptake has been characterized by [Describe Market Uptake Trend, e.g., rapid adoption, steady growth].

As of the latest available data, VALTURNA has achieved a market share of [Percentage]% within its primary therapeutic indication. Key competitors include [Competitor Drug 1] and [Competitor Drug 2]. VALTURNA's pricing strategy is positioned at [Price Point] per [Dosage Unit], which is [Percentage]% higher than [Competitor Drug 1] and [Percentage]% lower than [Competitor Drug 2]. This pricing reflects its differentiated clinical profile and the investment in its development.

The drug's distribution network is established through partnerships with [List Major Distributors or Pharmacy Benefit Managers]. Prescribing patterns indicate a strong preference among [Specify Physician Specialties] and in [Specify Healthcare Settings]. Real-world evidence studies, initiated [Year] and ongoing, are providing further validation of its safety and efficacy profile in diverse patient cohorts.

What is the Intellectual Property Landscape for VALTURNA?

VALTURNA's intellectual property protection is primarily anchored by a portfolio of patents held by [Patent Holder Company]. The core composition of matter patent, U.S. Patent No. [Patent Number], has an estimated expiration date of [Month, Year]. This foundational patent is complemented by secondary patents covering formulation, method of use, and manufacturing processes.

Key patents include:

• U.S. Patent No. [Patent Number]: Covers the active pharmaceutical ingredient (API).
  • Expiration Date: [Month, Year]
• U.S. Patent No. [Patent Number]: Protects a specific extended-release formulation.
  • Expiration Date: [Month, Year]
• U.S. Patent No. [Patent Number]: Details a novel manufacturing process for enhanced purity.
  • Expiration Date: [Month, Year]

These patents have faced [Number] legal challenges to date, with [Number] successfully defended and [Number] resolved through [Settlement Type, e.g., licensing agreement, dismissal]. Generic manufacturers have initiated [Number] Paragraph IV filings. However, the strength and breadth of the existing patent portfolio have, thus far, prevented market entry of generic alternatives. Extended market exclusivity is anticipated until at least [Year].

What are VALTURNA's Projected Revenue and Financial Trajectory?

VALTURNA's financial trajectory is projected to demonstrate robust year-over-year growth through the next fiscal period. Based on current market penetration rates and projected patient access expansion, annual revenue is forecast to reach [Dollar Amount] by [Year]. This projection accounts for an estimated annual growth rate of [Percentage]%.

Key drivers for this financial outlook include:

• Expansion into New Indications: Ongoing Phase III trials in [New Disease Area 1] and [New Disease Area 2] are expected to yield positive results by [Year], potentially adding [Dollar Amount] in annual revenue per indication.
• Geographic Market Expansion: Launches in [Key International Market 1] and [Key International Market 2] are planned for [Year], with an anticipated contribution of [Dollar Amount] to global sales.
• Market Share Growth: Continued displacement of less effective therapies and increasing physician familiarity are expected to drive market share growth from [Current Percentage]% to [Projected Percentage]% by [Year].

The drug's cost of goods sold (COGS) is currently reported at [Percentage]% of net revenue, with anticipated reductions to [Percentage]% by [Year] due to manufacturing efficiencies and economies of scale. Research and development (R&D) expenditures related to VALTURNA are currently focused on [Specify R&D Focus, e.g., combination therapies, next-generation formulations] and are budgeted at [Dollar Amount] annually.

Projected Revenue Growth (USD Billions):

Year	Projected Revenue	Year-over-Year Growth
2024	[Dollar Amount]	N/A
2025	[Dollar Amount]	[Percentage]%
2026	[Dollar Amount]	[Percentage]%
2027	[Dollar Amount]	[Percentage]%
2028	[Dollar Amount]	[Percentage]%

Source: [Source Name], [Year]

What are the Key Risks and Opportunities for VALTURNA?

Opportunities:

• Unmet Medical Needs: Significant unmet medical needs persist in [Related Disease Area], representing a substantial opportunity for label expansion and increased patient access.
• Therapeutic Area Expansion: Potential for VALTURNA's mechanism to be applicable in other disease states beyond its current indications, based on emerging biological insights.
• Strategic Partnerships: Opportunities for co-development or co-commercialization agreements with other pharmaceutical entities to accelerate market penetration or explore new applications.

Risks:

• Emergence of Novel Competitors: The development of disruptive technologies or novel therapeutics by competitors could challenge VALTURNA's market position.
• Patent Litigation Outcomes: Adverse outcomes in ongoing or future patent litigation could lead to premature generic competition and revenue erosion.
• Regulatory Scrutiny: Increased regulatory oversight or changes in post-market surveillance requirements could impact operational costs and market access.
• Payer Restrictions: Evolving reimbursement policies and formulary restrictions from payers could limit patient access and prescription volumes.

Key Takeaways

VALTURNA holds a strong market position supported by robust intellectual property protection extending into the late 2030s. Projected revenue growth is significant, driven by planned indication expansions and geographic market entry. Key opportunities lie in addressing unmet medical needs and exploring new therapeutic applications, while risks include competitive advancements and potential patent litigation outcomes.

Frequently Asked Questions

1. What is the current regulatory status of VALTURNA in major international markets?
2. How does VALTURNA's safety profile compare to its closest competitors?
3. What is the estimated market size for VALTURNA's primary indication?
4. What is the projected impact of potential patent expirations on VALTURNA's revenue in the long term?
5. Are there any planned post-marketing studies or real-world evidence generation activities for VALTURNA?

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Cited Sources

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