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. Eight 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:	102
Clinical Trials:	104
Patent Applications:	521
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	7,105,530
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009	7,262,203
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009	8,114,885

International Patents for VOTRIENT

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

Country	Patent Number	Title	Estimated Expiration
Hungary	0400691
Israel	156306	5 - ({4 - [(2,3 - DIMETHYL l - 2H - INDAZOL - 6 - YL)(METHYL) AMINO] PYRIMIDIN - 2 - YL} AMINO) - 2 -
Portugal	1343782

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	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	C01343782/01	Switzerland		FORMER OWNER: GLAXOSMITHKLINE LLC, US

Market Dynamics and Financial Trajectory for Votrient

Introduction to Votrient

Votrient, also known as pazopanib, is a protein-kinase inhibitor used in the treatment of advanced renal-cell carcinoma (RCC) and soft-tissue sarcoma. Developed by GlaxoSmithKline (GSK), it has been approved by regulatory bodies such as the FDA and the European Medicines Agency (EMA)[1][3].

Mechanism of Action

Votrient works by blocking specific enzymes known as protein kinases, which are involved in the growth and spread of cancer cells. These enzymes include VEGFR, PDGFR, and KIT, which are crucial for the formation of new blood vessels that tumors need to grow[1].

Clinical Efficacy

Clinical trials have shown that Votrient is more effective than placebo in treating advanced RCC and soft-tissue sarcoma. For RCC, patients treated with Votrient had a median progression-free survival (PFS) of 9.2 months, compared to 4.2 months for those receiving placebo. In the case of soft-tissue sarcoma, the median PFS was 20 weeks with Votrient versus seven weeks with placebo[1][3].

Regulatory Approval

Votrient received conditional marketing authorization from the European Commission in June 2010, which was later converted to full marketing authorization in July 2013 after additional evidence was provided. In the U.S., the FDA approved Votrient for advanced RCC in October 2009[1][3].

Market Segmentation

The global kidney cancer drugs market, which includes Votrient, is segmented by type, product, and end users. Votrient falls under the category of RCC treatments and competes with other drugs like Nexavar (Sorafenib), Sutent (Sunitinib), and Afinitor (Everolimus)[4].

Market Trends

The kidney cancer drugs market has experienced fluctuations due to various factors. The COVID-19 pandemic led to a decline in the market from $3.3 billion in 2020 to $3.29 billion in 2021, primarily due to the deferment of treatments for immunocompromised patients. However, the market is expected to recover and reach $3.6 billion by 2025, growing at a CAGR of 2.3%[4].

Competitive Landscape

Votrient faces significant competition from other targeted therapies and immune-oncology agents. Major players in the kidney cancer drugs market include Bayer AG, Pfizer Inc., Novartis International AG, Exelixis, Inc., and F. Hoffmann-La Roche AG. The increasing competition, especially from immune-oncology agents, has led to a decline in Votrient sales[2][5].

Financial Performance

Sales Decline

Votrient's sales have been declining due to increased competition. In the third quarter of 2023, Votrient sales dropped by 14% compared to the previous year, largely due to the rise of immune-oncology agents in metastatic treatments[2].

Revenue Figures

In the first quarter of 2023, Votrient generated $105 million in sales, which was a 19% decline compared to the same period in the previous year. This decline is consistent with the trend observed in the third quarter of 2023, where sales also dropped by 14%[5].

Impact on Company Financials

The decline in Votrient sales has had a noticeable impact on the financial performance of its parent company. While the overall net sales and core operating income of Novartis (which acquired GSK's oncology portfolio) have shown growth, the specific decline in Votrient sales has been a contributing factor to the challenges faced by the company in maintaining its market share in the oncology segment[2][5].

Future Outlook

Despite the current decline, Votrient remains a significant player in the treatment of advanced RCC and soft-tissue sarcoma. However, its market position is under pressure due to the emergence of new therapies and the evolving landscape of cancer treatment.

Market Recovery

The kidney cancer drugs market is expected to recover and grow modestly over the next few years. As the market adjusts to post-pandemic conditions and new treatments become available, Votrient may need to adapt to maintain its market share[4].

Strategic Considerations

To mitigate the impact of increased competition, GSK and its successors may need to focus on strategic marketing, expanding the drug's indications, or developing combination therapies that include Votrient. This could help in retaining and potentially growing the patient base.

Key Takeaways

• Clinical Efficacy: Votrient has demonstrated significant efficacy in treating advanced RCC and soft-tissue sarcoma.
• Regulatory Approval: It has received full marketing authorization in the EU and FDA approval in the U.S.
• Market Trends: The kidney cancer drugs market is recovering from pandemic-related declines but faces intense competition.
• Financial Performance: Votrient sales have declined due to increased competition from immune-oncology agents.
• Future Outlook: The drug's market position is under pressure, but strategic adaptations could help in maintaining its relevance.

FAQs

What is Votrient used for?

Votrient is used to treat patients with advanced renal-cell carcinoma (RCC) and soft-tissue sarcoma.

How does Votrient work?

Votrient works by blocking specific protein kinases involved in the growth and spread of cancer cells.

What are the main competitors of Votrient?

Votrient competes with other targeted therapies such as Nexavar, Sutent, Afinitor, and immune-oncology agents.

Why have Votrient sales declined?

Votrient sales have declined due to increased competition from immune-oncology agents in metastatic treatments.

What is the future outlook for Votrient in the market?

The future outlook for Votrient is challenging due to competition, but strategic adaptations and market recovery could help in maintaining its market share.

Sources

1. European Medicines Agency (EMA). Votrient | European Medicines Agency (EMA).
2. Novartis. Novartis Q3 2023 Condensed Interim Financial Report.
3. GlaxoSmithKline. FDA approves GlaxoSmithKline's Votrient™ for advanced renal cell cancer.
4. GlobeNewswire. Kidney Cancer Drugs Industry Assessment and Recovery to 2030.
5. Novartis. Novartis Q1 2023 Condensed Financial Report – Supplementary Data.