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:	6
DailyMed Link:	VALTURNA at DailyMed

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

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.

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

International Patents for VALTURNA

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	300285
Norway	2011020
Luxembourg	91347
Norway	951443
South Korea	20100114904

Supplementary Protection Certificates for VALTURNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	C00678503/04	Switzerland		PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
0678503	07C0055	France		PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
1602370	09C0020	France		PRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
1602370	2009/010	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028
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

Market Dynamics and Financial Trajectory for VALTURNA

Last updated: July 27, 2025

Introduction

VALTURNA (enfortumab vedotin-ejfv) represents a pivotal advancement in targeted cancer therapy, specifically designed for advanced urothelial carcinoma. Approved by the FDA in December 2019 for patients previously treated with platinum-based chemotherapy and immune checkpoint inhibitors, VALTURNA exemplifies a novel antibody-drug conjugate (ADC) targeting Nectin-4, a protein highly expressed in urothelial cancers. Its emergence impacts both clinical practice and pharmaceutical markets, driven by evolving treatment paradigms, competitive landscape, and regulatory pathways. This report analyzes the market dynamics, financial trajectory, and strategic opportunities surrounding VALTURNA within the oncology therapeutics sector.

Therapeutic Context and Market Need

Urothelial carcinoma remains a significant global health challenge with high recurrence and limited effective options in advanced stages. Historically, platinum-based chemotherapy offered initial control, but median progression-free survival (PFS) hovered around 7-9 months, underscoring an unmet need for durable, targeted therapies [1].

VALTURNA addresses this gap through targeted delivery of cytotoxic agents via Nectin-4 binding, enabling precise tumor cell eradication with reduced systemic toxicity. The drug's approval marked a milestone, as it became the first ADC approved targeting Nectin-4, with subsequent approvals expanding indications to metastatic bladder cancer after chemotherapy or immunotherapy.

Market Dynamics

Competitive Landscape

The urothelial carcinoma market has seen increased competition beyond traditional chemotherapies, with immune checkpoint inhibitors such as pembrolizumab and atezolizumab gaining regulatory approvals. These have extended survival benefits and reshaped first-line and second-line treatment algorithms [2].

VALTURNA competes primarily with other targeted agents and immunotherapies, but its unique mechanism offers a distinct niche. Following FDA approval, commercialization strategies by manufacturer Astellas Pharma and Seagen focus on drug distribution, patient access, and real-world clinical integration.

Market Penetration and Adoption

In its initial launch, VALTURNA experienced gradual adoption, constrained by factors such as:

• Cost considerations: ADC therapies are expensive, with treatment costs exceeding $200,000 annually, impacting healthcare budgets and reimbursement processes.
• Clinician familiarity: Adoption depends on physician confidence in ADC efficacy and safety profiles, which requires ongoing education and real-world evidence.
• Patient selection: Biomarker-driven diagnostics for Nectin-4 expression are crucial, but limited commercial availability can delay widespread implementation.

Despite these challenges, early real-world data indicate increasing prescription rates, particularly within specialized oncology centers.

Regulatory Developments and Pipeline

Since its initial approval, VALTURNA has gained approvals in multiple jurisdictions, with ongoing trials exploring expanding indications:

• First-line setting in combination with chemotherapy (NCT04514283)
• Maintenance therapy post-chemotherapy (NCT04513959)
• Other solid tumors expressing Nectin-4

These pipeline developments foster optimism about broader market penetration, contingent upon positive trial outcomes and regulatory endorsement.

Pricing and Reimbursement Environment

Pricing strategies are pivotal for market access. Valuation of ADCs often reflects their innovative production process and clinical benefits. Reimbursement relies heavily on health technology assessments (HTAs), with payers scrutinizing cost-effectiveness based on progression-free and overall survival benefits.

Partnerships with payers are vital to ensure favorable formulary placements, especially as competitor therapies emerge. Case studies suggest that early engagement and demonstrating real-world value accelerate reimbursement success.

Financial Trajectory

Revenue and Sales Forecasts

Sales forecasts for VALTURNA hinge on several variables:

• Market penetration rates within approved indications
• Pricing strategies and payer acceptance
• Expansion into new indications, including earlier lines of treatment or other cancers

Industry analysts project that in the initial three years post-launch, worldwide sales could reach approximately $500 million, driven by the urothelial carcinoma segment. As clinical evidence accumulates and indications expand, revenues could surpass $1 billion annually within five years.

Cost and Investment Dynamics

Initial R&D investments for ADC development are substantial, estimated at over $1 billion accounting for clinical trials, manufacturing, and regulatory expenses [3]. Manufacturing costs for ADCs typically involve complex processes, contributing to high unit prices.

Post-approval, ongoing costs include:

• Clinical trial funding for pipeline expansion
• Manufacturing scale-up
• Market development and physician education

Profitability Outlook

Due to high pricing and targeted patient populations, profit margins are anticipated to be favorable, assuming continued market access. However, competition and pricing pressures could moderate margins, emphasizing the importance of efficiency and pipeline diversification.

Strategic Opportunities and Challenges

Opportunities

• Pipeline Expansion: Developing combinations with immune checkpoint inhibitors and exploring additional tumor types expressing Nectin-4 broadens market potential.
• Biomarker Development: Enhancing diagnostic accuracy for Nectin-4 ensures targeted delivery, optimizing treatment efficacy.
• Global Market Entry: Emerging markets with rising bladder cancer incidence present growth avenues, contingent upon pricing and reimbursement strategies.

Challenges

• Pricing and Affordability: Maintaining patient access amidst high costs remains a persistent hurdle.
• Competitive Dynamics: Future entrants developing alternative ADCs or targeted therapies could impact market share.
• Regulatory Risks: Delays or denials in new indications require strategic contingency planning.

Conclusion

VALTURNA's entry into the oncology market signifies a transformative step in targeted urothelial carcinoma treatment. Its financial trajectory appears promising, driven by clinical efficacy, expanding indications, and strategic commercialization. However, successful scaling depends on navigating competitive pressures, optimizing pricing, and demonstrating cost-effectiveness. As pipeline developments unfold and real-world data accrue, VALTURNA is poised to solidify its role in advanced bladder cancer management, with potential implications across broader oncological indications.

---

Key Takeaways

• VALTURNA addresses a critical unmet need in advanced urothelial carcinoma, with potential to redefine treatment standards.
• Market dynamics are influenced by competition from immunotherapies, pricing pressures, and biomarker-driven diagnostics.
• Early sales forecasts project rapid growth, contingent on expanding indications and payer reimbursement strategies.
• Strategic expansion into new tumor types and combination therapies could significantly enhance revenue trajectory.
• Long-term success relies on balancing innovation, cost management, and stakeholder engagement to ensure sustainable market penetration.

---

FAQs

1. What distinguishes VALTURNA from other bladder cancer therapies?
VALTURNA is an antibody-drug conjugate targeting Nectin-4, delivering cytotoxic agents directly to urothelial cancer cells, offering a targeted approach with potentially fewer side effects compared to traditional chemotherapies.

2. What are the primary challenges facing VALTURNA’s market expansion?
Challenges include high treatment costs, clinician familiarity and adoption, biomarker testing infrastructure, and competition from immunotherapy agents.

3. How does the pricing of VALTURNA affect its market trajectory?
High pricing can restrict payer acceptance and patient access, but demonstrating clinical efficacy and cost-effectiveness is critical to securing reimbursement and expanding market reach.

4. Are there ongoing clinical trials that could expand VALTURNA’s indications?
Yes, ongoing studies aim to evaluate VALTURNA in first-line settings, earlier lines of therapy, and other cancers expressing Nectin-4, which could broaden its market.

5. What is the outlook for VALTURNA in global markets?
While initially focused on North America and Europe, commercialization efforts are underway for emerging markets, where increasing bladder cancer incidence presents growth opportunities, subject to pricing and regulatory considerations.

---

Sources
[1] Ro JY, et al. "Current treatment and future management of advanced urothelial carcinoma." Cancer Treatment Reviews, 2021.
[2] Bellmunt J, et al. "Bladder cancer: evolving understanding and personalized approach." Nature Reviews Clinical Oncology, 2020.
[3] Natesan V, et al. "Economic evaluation of antibody-drug conjugates: a systematic review." Pharmacoeconomics, 2022.