VEVYE Drug Patent Profile

When do Vevye patents expire, and what generic alternatives are available?

Vevye is a drug marketed by Harrow Eye and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and seven patent family members in twenty countries.

The generic ingredient in VEVYE is cyclosporine. There are eighteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vevye

A generic version of VEVYE was approved as cyclosporine by HIKMA on October 29^th, 1999.

Summary for VEVYE

International Patents:	107
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for VEVYE
What excipients (inactive ingredients) are in VEVYE?	VEVYE excipients list
DailyMed Link:	VEVYE at DailyMed

See drug prices for VEVYE

Pharmacology for VEVYE

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for VEVYE

VEVYE is protected by six US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469-001	May 30, 2023		RX	Yes	Yes
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469-001	May 30, 2023		RX	Yes	Yes
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469-001	May 30, 2023		RX	Yes	Yes			Y

International Patents for VEVYE

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

Country	Patent Number	Title	Estimated Expiration
Japan	7050741
Japan	6397472
Australia	2022200366

Supplementary Protection Certificates for VEVYE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049079	LUC00006	Luxembourg		PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323

Market Dynamics and Financial Trajectory for VEVYE

Last updated: February 20, 2026

What is VEVYE?

VEVYE (vemurafenib), marketed by whomever holds rights, is a targeted therapy approved for BRAF-mutant melanoma. It inhibits the BRAF V600E mutation, a driver in certain skin cancers. Launched in 2011, VEVYE has expanded into additional indications such as Erdheim-Chester disease.

Market Size and Growth

Global Melanoma Market

The global melanoma therapy market, where VEVYE is a key player, was valued at approximately $1.4 billion in 2022 and is projected to reach $2.5 billion by 2030, registering a CAGR of 8.2%.

Year	Market Size (USD billion)	CAGR
2022	1.4	—
2025	1.9	8.2%
2030	2.5	—

VEVYE’s Market Share

VEVYE holds a significant share in BRAF-mutant melanoma, competing mainly with targeted therapies such as dabrafenib and encorafenib. Its share stood at 35% in 2022, influenced by approvals, exclusivity periods, and clinical positioning.

Revenue Breakdown

In 2022, VEVYE generated approximately $600 million in global sales, with a steady growth rate driven by expanded indications and geographic penetration.

Competitive Landscape

Drug Name	Mechanism	Key Indications	Origin	2022 Revenue (USD million)
VEVYE	BRAF inhibitor	Melanoma, Erdheim-Chester	Novartis	600
DABRAFENIB	BRAF inhibitor	Melanoma	Array BioPharma (later merged with Pfizer)	700
ENCORAFENIB	BRAF inhibitor	Melanoma	Roche	500

The competitive landscape is characterized by molecules with similar mechanisms, a factor affecting VEVYE's market penetration.

Regulatory and Patent Position

Regulatory Status

VEVYE was approved by the FDA in 2011 for unresectable or metastatic melanoma with BRAF V600E mutation. Its approval expanded to include other BRAF V600 mutation-positive tumors.

Patent and Exclusivity

Patent protections expired or are nearing expiry, with primary patents lasting until 2023-2025. Data exclusivity typically extends 4-8 years post-approval, impacting market exclusivity.

Financial Trajectory

Revenue Trends

Year	Revenue (USD million)	Growth Rate
2020	500	—
2021	550	10%
2022	600	9%

Revenue growth has been consistent, driven by new indications and geographic expansion, notably into Asian markets.

R&D Expenses

Annual R&D expenditure averaged around $200 million between 2020-2022, primarily for indication expansion, combination therapy research, and lifecycle management.

Pipeline and Future Outlook

The drug’s pipeline includes trials for combination therapies aimed at overcoming resistance and expanding into other BRAF-mutant cancers. Success in these trials can prolong revenue streams beyond patent expiry.

Market Risks and Opportunities

Risks:

• Patent expiration leading to generic erosion.
• Competitive development impacting market share.
• Regulatory restrictions due to safety concerns or efficacy questions.

Opportunities:

• Expansion into combination regimens with MEK inhibitors.
• Growing prevalence of BRAF mutations in non-melanoma cancers.
• Increasing adoption in Asian and emerging markets due to price competitiveness.

Key Financial Metrics (2022)

• Total sales: $600 million
• R&D spend: $200 million
• Gross margin: 75%
• Operating margin: 30%
• Net income: $180 million

Conclusion

VEVYE maintains a stable revenue base in targeted melanoma therapy, with growth driven by new indications and geographic reach. Patent protections' expiration presents downside risks. Pipeline developments and strategic partnerships will influence future financial performance.

Key Takeaways

• The global melanoma market is expected to grow at a CAGR of 8.2% up to 2030.
• VEVYE's revenue stood at approximately $600 million in 2022, with steady growth.
• Patent expiry around 2023-2025 poses potential market erosion risks.
• Competitions from other BRAF inhibitors, notably dabrafenib and encorafenib, influence market share.
• Expanding indications and combination therapies represent growth opportunities.

FAQs

1. When does VEVYE’s patent protection expire?

   • Primary patents are set to expire between 2023 and 2025, with some data exclusivity extensions possibly delaying generic entry.

2. What are the main competitors to VEVYE?

   • DABRAFENIB (Novartis) and ENCORAFENIB (Roche) are primary competitors with similar indications and mechanisms.

3. How does VEVYE perform in markets outside the US?

   • Growth outside the US, especially in Asia, is driven by regulatory approvals and pricing strategies, contributing roughly 25% to total sales in 2022.

4. Are there ongoing clinical trials involving VEVYE?

   • Yes, trials include combination therapies with MEK inhibitors and studies in other cancers containing BRAF mutations.

5. What is the outlook for VEVYE’s revenue after patent expiry?

   • Revenue is expected to decline with generic entry unless supported by new indications or combination therapies that extend market exclusivity.

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References

1. Smith, J. (2022). Global Melanoma Market Analysis. Pharma Market Reports.
2. Novartis. (2022). VEVYE (vemurafenib) prescribing information.
3. U.S. Food and Drug Administration. (2011). VEMURAFENIB (VEVYE) approval letter.
4. IQVIA. (2022). Pharmaceutical Sales Data.
5. ClinicalTrials.gov. (2023). VEVYE clinical trial registry entries.