VOTRIENT Drug Patent Profile

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

Votrient is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in VOTRIENT is pazopanib hydrochloride. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the pazopanib hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Votrient

A generic version of VOTRIENT was approved as pazopanib hydrochloride by APOTEX on October 19^th, 2023.

Summary for VOTRIENT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	104
Patent Applications:	186
Drug Prices:	Drug price information for VOTRIENT
What excipients (inactive ingredients) are in VOTRIENT?	VOTRIENT excipients list
DailyMed Link:	VOTRIENT at DailyMed

See drug prices for VOTRIENT

Recent Clinical Trials for VOTRIENT

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

Sponsor	Phase
University Medical Center Groningen	Phase 4
Centre Leon Berard	Phase 1/Phase 2
National Cancer Institute, France	Phase 1/Phase 2

See all VOTRIENT clinical trials

Pharmacology for VOTRIENT

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

US Patents and Regulatory Information for VOTRIENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009	AB	RX	Yes	Yes
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009		DISCN	Yes	No

Expired US Patents for VOTRIENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009

International Patents for VOTRIENT

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1343782
European Patent Office	1343782	COMPOSES CHIMIQUES (PYRIMIDINEAMINES AS ANGIOGENESIS MODULATORS)
Germany	122010000038
Israel	156306	5 - ({4 - [(2,3 - DIMETHYL l - 2H - INDAZOL - 6 - YL)(METHYL) AMINO] PYRIMIDIN - 2 - YL} AMINO) - 2 -
Portugal	1343782
Cyprus	1117079
Austria	430742

Supplementary Protection Certificates for VOTRIENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1343782	2010C/030	Belgium		PRODUCT NAME: PAZOPANIB, OPTIONNELLEMENT SOUS LA FORME DE SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU DE SON SOLVATE; AUTHORISATION NUMBER AND DATE: EU/1/110/628/01 20100616
1343782	389	Finland
1343782	C300456	Netherlands		PRODUCT NAME: PAZOPANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT, IN HET BIJZONDER PAZOPANIB HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/10/628/001-004 20100614
1343782	122010000038	Germany		PRODUCT NAME: PAZOPANIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/10/628/001-004 20100614
1343782	C01343782/01	Switzerland		FORMER OWNER: GLAXOSMITHKLINE LLC, US
1343782	91710	Luxembourg		91710, EXPIRES: 20250614
1343782	10C0037	France		PRODUCT NAME: PAZOPANIB; REGISTRATION NO/DATE: EU/1/110/628/001 20100614

Market Dynamics and Financial Trajectory for VOTRIENT (Pazopanib)

Last updated: July 27, 2025

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Introduction

VOTRIENT (pazopanib) is an oral multi-kinase inhibitor primarily approved for the treatment of advanced renal cell carcinoma (RCC) and soft tissue sarcoma (STS). Since its launch by Novartis in 2009, VOTRIENT has carved a distinct position within the targeted oncology landscape. Understanding the intricate market dynamics and projected financial trajectory of VOTRIENT requires a comprehensive analysis of clinical positioning, market competition, regulatory landscape, and evolving treatment paradigms.

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Market Overview

Current Indications and Treatment Landscape

VOTRIENT is approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for advanced RCC following cytokine therapy failure and for certain STS subtypes post-chemotherapy. Its mechanism involves inhibition of vascular endothelial growth factor receptors (VEGFRs) and other kinases, disrupting tumor angiogenesis—a critical pathway in oncology.

The global oncology drug market, valued at approximately USD 180 billion in 2022 (per GlobalData), continues to grow driven by increasing cancer prevalence, innovations in targeted therapy, and personalized medicine shifts. VOTRIENT occupies a niche within targeted therapies, with its primary competition emanating from other VEGFR inhibitors, such as sunitinib, sorafenib, and newer agents like avelumab and immunotherapies, which are gradually expanding treatment options for RCC and STS.

Market Share and Competitive Positioning

Since its launch, VOTRIENT's market share has been influenced by efficacy profiles, adverse event management, and evolving treatment guidelines. While it maintains a strong position in second-line RCC, its competition from tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) has resulted in a competitive landscape where its relative market share is gradually declining. Nonetheless, exclusivity in indications and solid clinical trial data bolster its position, especially for patients intolerant of immunotherapies.

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Regulatory and Clinical Development Trajectory

The regulatory environment is pivotal for sustaining and expanding VOTRIENT’s market access. Ongoing clinical trials for additional indications—such as first-line RCC, hepatocellular carcinoma (HCC), and other sarcomas—serve as avenues for growth.

Recent approvals or trial results could enhance its usage, particularly if future data depict superior efficacy or safety profiles compared to emerging therapies. Regulatory agencies also emphasize safety profiles; VOTRIENT’s manageable toxicity has historically contributed to its acceptability.

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Market Dynamics Influencing VOTRIENT’s Financial Trajectory

1. Competitive Oncology Ecosystem

The oncology market is highly competitive with rapid innovation cycles. The advent of immunotherapies, such as PD-1/PD-L1 inhibitors, has shifted frontline RCC treatment paradigms. For example, combinations like pembrolizumab with axitinib demonstrate superior efficacy in extending progression-free survival (PFS), impacting VOTRIENT’s positioning [2].

This shifting paradigm pressures VOTRIENT’s sales, especially for earlier lines. Nonetheless, in later-line settings or for patients ineligible for immunotherapy, VOTRIENT retains clinical value.

2. Evolving Treatment Guidelines

Leading oncology guidelines increasingly incorporate immunotherapy-based regimens, influencing prescription behaviors. However, VOTRIENT’s role persists in niche populations—particularly in cases of contraindications or resistance to immune therapies. Its label extensions or new indications emerging from ongoing trials can sway its market share favorably.

3. Pricing Strategies and Reimbursement Policies

Pricing pressures from payers, driven by cost-effectiveness analyses and comparative effectiveness research, impact revenue streams. VOTRIENT’s cost per quality-adjusted life-year (QALY) benchmarks influence reimbursement, especially in markets with value-based pricing models.

Novartis’s strategy to sustain competitiveness involves differential pricing, patient assistance programs, and engaging with health authorities to demonstrate value.

4. Patent and Exclusivity Landscape

VOTRIENT’s primary patent protections are increasingly challenged by generic competitors once exclusivity expires, potentially around 2024-2025. This expiry could lead to significant revenue erosion unless similar patent extensions or second-generation formulations are developed.

5. Pipeline and Off-Label Opportunities

Development of combination therapies involving VOTRIENT with immunotherapies is underway. Initial trials suggest potential synergistic effects, which could rejuvenate its market prospects if approved.

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Financial Trajectory Forecast

Historical Performance

VOTRIENT’s global sales peaked around USD 1.1 billion in 2014-2015. Since then, revenues have plateaued and declined modestly due to market saturation and therapeutic competition [3].

Forecast Snapshot (2023-2028)

• Short-term (2023-2025): Revenues are expected to stabilize with gradual decline unless new indications or formulations are approved. The expiration of key patents, along with the rising prominence of combination immunotherapies, will intensify competition.

• Mid-term (2025-2028): Revenue decline may accelerate unless Novartis secures new indications or develops next-generation formulations. Conversely, if ongoing trials demonstrate superior outcomes or if combinatorial regimens are approved, revenue could stabilize or even grow.

• Long-term (Beyond 2028): Market penetration in emerging markets, biosimilar competition, and the success of pipeline drugs will primarily determine sustainability. Analogous to other TKIs, significant patent expirations threaten revenue streams unless strategic patent protections or formulations are employed.

Revenue Drivers and Risks

Driver	Impact	Risks
New Indications	Potential revenue growth	Regulatory hurdles or trial failures
Combination Therapy Approvals	Revalidation of value	Market acceptance challenges
Patent Expiry	Revenue decline	Imitator penetration with generics
Market Penetration in Emerging Countries	Revenue expansion	Pricing and reimbursement barriers

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Future Outlook and Strategic Considerations

VOTRIENT’s trajectory depends heavily on its ability to adapt to a competitive, innovation-driven environment. Strategic moves such as expanding indications, participating in combination trials, and securing patent protections are critical.

Novartis’s embrace of personalized medicine and development pipelines may offset downside risks associated with patent cliffs. Additionally, the increasing adoption of targeted therapy and immunotherapy combinations positions VOTRIENT favorably if clinical data continue demonstrating efficacy.

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Key Takeaways

• Market position: VOTRIENT maintains a niche role in later-line RCC and certain STS, but faces erosion from immunotherapy and newer TKIs.
• Competitive pressures: The rapid evolution of combination treatments and first-line regimens challenge its therapeutic relevance.
• Revenue outlook: Expect gradual decline post-patent expiry unless new indications or formulations are approved.
• Growth opportunities: Clinical trials exploring combinations and new indications could extend its market life.
• Strategic focus: Continuous clinical development, patent protections, and market adaptation are essential for sustained financial viability.

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FAQs

1. What are the primary indications for VOTRIENT?
VOTRIENT (pazopanib) is approved for advanced renal cell carcinoma and certain soft tissue sarcomas. Its indications include treatment for metastatic RCC after cytokine therapy failure and for specific sarcoma subtypes following chemotherapy.

2. How does VOTRIENT compare to other VEGFR inhibitors?
VOTRIENT offers comparable efficacy to other TKIs like sunitinib but is distinguished by its safety profile and oral administration. However, emerging data favor combination immunotherapies, which are increasingly preferred in frontline settings.

3. What are the main challenges facing VOTRIENT’s market growth?
Key challenges include competition from immunotherapy-based regimens, patent expiration leading to generic entry, and evolving treatment guidelines favoring newer therapies.

4. Are there ongoing trials that could enhance VOTRIENT’s market potential?
Yes, ongoing trials are exploring VOTRIENT in combinations with immune checkpoint inhibitors and in additional tumor types, which could broaden its utility and market share if successful.

5. What strategic moves should Novartis consider to maximize VOTRIENT’s value?
Novartis should focus on expanding indications through clinical trials, securing patent protections, engaging in strategic partnerships, and positioning VOTRIENT within combination therapies to remain competitive.

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References

[1] GlobalData. Oncology Market Size & Trends, 2022.
[2] Motzer RJ, et al. Nivolumab plus cabozantinib versus sunitinib in untreated RCC. N Engl J Med. 2022.
[3] Novartis Annual Reports 2015-2022.