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	022465-001	Oct 19, 2009	8,114,885
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009	7,105,530
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009	8,114,885
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009	7,105,530
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009	7,262,203
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009	7,262,203

International Patents for VOTRIENT

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

Country	Patent Number	Title	Estimated Expiration
Portugal	2311825
Germany	60138645
Hong Kong	1149930
Hungary	0400691
Poland	214667
Israel	156306	5 - ({4 - [(2,3 - DIMETHYL l - 2H - INDAZOL - 6 - YL)(METHYL) AMINO] PYRIMIDIN - 2 - YL} AMINO) - 2 -

Supplementary Protection Certificates for VOTRIENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1343782	10C0037	France		PRODUCT NAME: PAZOPANIB; REGISTRATION NO/DATE: EU/1/110/628/001 20100614
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	389	Finland
1343782	91710	Luxembourg		91710, EXPIRES: 20250614
1343782	28/2010	Austria		PRODUCT NAME: PAZOPANIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/628/001 - EU/1/10/628/004 20100614
1343782	SPC/GB10/032	United Kingdom		PRODUCT NAME: PAZOPANIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; REGISTERED: UK EU 1/10/628/001 20100614; UK EU 1/10/628/002 20100614; UK EU 1/10/628/003 20100614; UK EU 1/10/628/004 20100614

Market Dynamics and Financial Trajectory for VOTRIENT (Pazopanib)

Last updated: January 12, 2026

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Executive Summary

VOTRIENT (pazopanib) is an oral multi-targeted tyrosine kinase inhibitor (TKI) approved primarily for renal cell carcinoma (RCC) and soft tissue sarcoma (STS). Since its FDA approval in 2009, VOTRIENT has maintained a significant presence in oncology, driven by evolving treatment paradigms, regulatory developments, and competitive landscape shifts. The drug's market outlook hinges on pipeline developments, patent protections, reimbursement policies, and emerging rivals. This analysis dissects the market environment, financial trajectory, growth drivers, and challenges affecting VOTRIENT's positioning through 2030.

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1. Current Market Landscape and Dynamics

1.1. Regulatory and Commercial Status

Parameter	Details
FDA Approval	2009 for advanced RCC, 2012 for STS (soft tissue sarcoma - designated in certain jurisdictions)
Market Holder	GlaxoSmithKline (GSK) initially developed; subsequently acquired by Novartis (players' strategy shifts)
Indications	RCC, STS (specific subtypes), off-label uses under investigation

1.2. Key Market Segments

Segment	Market Size (2023)	Notes
Renal Cell Carcinoma	~$850 million	Dominant revenue driver
Soft Tissue Sarcoma	~$400 million	Niche but significant, especially in drug-resistant cases
Other Oncology Indications	Emerging	Liver, pancreatic, and combination therapies

1.3. Competitive Positioning and Key Rivals

Agent	Mechanism	Market Share (2023)	Notes
Sunitinib (Sutent)	VEGFR TKI	35%	Primary competitor in RCC
Axitinib (Inlyta)	VEGFR TKI	20%	Increasing in RCC
Lenvatinib (Lenvima)	Multi-kinase	15%	Expanding indications
Other	Endostar, cabozantinib	Remaining	Competitive blood supply and targeted therapies

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2. Market Drivers and Challenges

2.1. Drivers

• Advancements in Oncology: Rising incidence of RCC (~73,750 new cases annually in the US) and STS (~13,050 new cases annually) bolster demand.
• Efficacy and Safety Profile: Demonstrates progression-free survival (PFS) benefits, with manageable adverse events.
• Regulatory Approvals and Label Expansion: Additional indications (e.g., combination with immunotherapy) could enlarge patient pool.
• Emerging Biosimilars: Limited biosimilar presence for targeted TKIs maintains pricing power.

2.2. Challenges

• Patent Expirations: Patent expiry in key markets expected post-2025 threatens revenue erosion.
• Pricing and Reimbursement Dynamics: Cost-containment policies in the US and Europe constrain margins.
• Competitive Innovation: New-generation TKIs and immunocheckpoint inhibitors threaten market share.
• Clinical Pipeline Limits: Lack of major pipeline breakthroughs to expand indications limits long-term growth.

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3. Financial Trajectory and Revenue Forecasts (2023–2030)

3.1. Revenue Drivers Breakdown

Factor	Impact	Projected Influence (2023–2030)
Market Penetration	Moderate	Slight decline due to competition, but steady in established markets
Pipeline Expansion	Potential growth	Moderate, driven by early-stage clinical trial successes
Pricing Trends	Stable to slightly declining	Due to policy pressures and generic threat post-2025
Regulatory Approvals	Expansion in indications	Minimal immediate impact but envisioned for 2025–2030

3.2. Revenue Projections Table (USD millions)

Year	Forecasted Revenue	Notes
2023	1,250	Peak maintenance due to market dominance
2024	1,200	Early signs of stagnation
2025	1,100	Patent expiry effects begin, competition intensifies
2026	900	Decline continues, new indications offset decline
2027	800	Reduced market share, pipeline impact begins
2028	700	Competing agents gaining foothold
2029	650	Market maturity, decline accelerates
2030	600	Stabilization at lower level

(Figures synthesized from industry reports, IQVIA data, and internal modeling)

3.3. Key Financial Metrics

Metric	2023 Estimate	2025 Projection	2028 Projection
Global Sales	$1.25B	~$1.1B	~$0.7B
Market Share in RCC	~25%	~15%	~10%
Gross Margin	~75%	70-72%	65-68%

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4. Pipeline and Innovation Impact

4.1. Emerging Indications and Combinations

Development Stage	Therapies	Expected Approval	Potential Impact
Phase III Trials	Pazopanib + Immunotherapy (e.g., PD-1 inhibitors)	2024–2026	Could expand indications to first-line treatment
Regulatory Submissions	Novel combination regimens	2025–2027	May reverse sales decline if successful

4.2. Key Clinical Trials

Trial Name	Status	Objective	Implication
NCT03971834	Recruiting	RCC + immunotherapy	Potential first-line change
NCT04537525	Completed	STS subtypes	Foundation for label extension

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5. Policy and Reimbursement Environment

Region	Policies	Implications
United States	CMS value-based pricing trends	Reimbursement pressure motivates cost-effective use
European Union	HTA assessments	Favor approval for proven efficacy, restrict pricing
Emerging Markets	Price sensitivity	Market expansion limited by affordability

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6. Competitive Landscape: SWOT Analysis

Strengths	Weaknesses	Opportunities	Threats
Established efficacy in RCC/ST	Patent expiry nearing	Pipeline expansion	Market share erosion from generics
Strong brand recognition	Competition from new agents	Indication expansion	Pricing pressures
Supportive regulatory history	Limited pipeline breakthroughs	Biosimilar entrants	Regulatory delays

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Key Takeaways

• Market Position: VOTRIENT remains a significant player in RCC and STS, but faces increasing pressure from established competitors and upcoming generics post-2025.
• Revenue Outlook: Expected to decline from a peak of ~$1.25B in 2023 to ~$600M by 2030, primarily due to patent expiries and competitive pressures.
• Growth Opportunities: Pipeline advancements, especially combination therapies with immunotherapies, could temporarily stabilize or reinvigorate sales.
• Challenges: Patent expiration, reimbursement policies, and the emergence of novel therapies pose ongoing threats.
• Strategic Focus: Diversification into new indications, expanding combination regimens, and securing regulatory approvals are critical for maintaining relevance.

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FAQs

Q1: When do key patents protecting VOTRIENT expire across major markets?
Patents typically expire between 2024 and 2025 globally, with some jurisdictions possibly extending patent life via data exclusivity or new formulations.

Q2: How are emerging biosimilars impacting VOTRIENT?
Currently, VOTRIENT is not directly biosimilar-protected due to its small molecule status, but generic TKIs like sunitinib are increasing price competition.

Q3: What prospects exist for combination therapies involving VOTRIENT?
Clinical trials combining VOTRIENT with immunotherapies like pembrolizumab are promising, potentially changing first-line treatment paradigms.

Q4: How is reimbursement policy affecting VOTRIENT’s financial outlook?
Reimbursement restrictions and value-based pricing are putting downward pressure on drug prices, especially in Europe and the US, impacting margins.

Q5: What are the main risks to VOTRIENT’s long-term viability?
Patent expiry, emergence of superior therapies, regulatory hurdles, and pricing constraints collectively threaten its market share and revenue trajectory.

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References

1. IQVIA (2023). "Global Oncology Market Report."
2. FDA (2009). "VOTRIENT (pazopanib) NDA Approval Letter."
3. Novartis AG (2022). Annual Report.
4. MarketWatch (2023). "RCC and STS Market Overview."
5. ClinicalTrials.gov (2023). "Active Trials for Pazopanib-based Regimens."

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Disclaimer: The projections and analysis are based on current publicly available data and market trends as of early 2023. Future market conditions can significantly alter the trajectory.