ZOSTAVAX Drug Profile

Summary for Tradename: ZOSTAVAX

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ZOSTAVAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOSTAVAX

Recent Clinical Trials for ZOSTAVAX

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Alabama at Birmingham	Phase 2
Oregon Health and Science University	Phase 2
University of Washington	Phase 4

See all ZOSTAVAX clinical trials

Recent Litigation for ZOSTAVAX

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC.	2024-01-19
NOVO NORDISK INC. v. DR. REDDY'S LABORATORIES, LTD.	2023-11-08
Teva Pharmaceuticals International GmbH v. BendaRx USA	2023-05-04

See all ZOSTAVAX litigation

PTAB Litigation

Petitioner	Date
Amneal Pharmaceuticals LLC et al.	2019-11-27
CSL Behring GmbH et al.	2018-12-21
	2018-09-28

See all ZOSTAVAX litigation

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ZOSTAVAX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ZOSTAVAX Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ZOSTAVAX Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2032-03-19	Patent claims search
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2039-09-23	Patent claims search
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2039-09-23	Patent claims search
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2035-03-18	Patent claims search
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2034-06-18	Patent claims search
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2032-10-31	Patent claims search
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2032-04-25	Patent claims search

ZOSTAVAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Zostavax

Introduction

Zostavax, a live, attenuated varicella-zoster virus vaccine, has been a significant player in the global zoster vaccine market. However, its market dynamics and financial trajectory have been influenced by several factors, including the introduction of newer vaccines, changing healthcare policies, and demographic shifts.

Market Size and Growth

The global zoster vaccine market, which includes Zostavax, was valued at USD 4.2 billion in 2023 and is expected to grow at a CAGR of 8.1% from 2024 to 2033, reaching USD 9.1 billion by 2033[1].

Competitive Landscape

The zoster vaccine market is dominated by several key products, with Shingrix leading the market. Shingrix, developed by GSK, holds around 42% of the market share due to its higher efficacy and longer-lasting protection compared to Zostavax[1].

Zostavax Market Share

While Zostavax was once a leading vaccine for shingles, its market share has declined significantly with the introduction of Shingrix. Zostavax, developed by Merck & Co., Inc., has seen a reduction in its sales as healthcare providers and patients prefer the more effective Shingrix vaccine.

Regional Performance

The global zoster vaccine market is segmented into several regions, with North America being the largest market. However, the Asia-Pacific region is expected to be the fastest-growing market due to expanding healthcare infrastructure and increasing public awareness about shingles vaccination[4].

Product Segmentation

The market is segmented by product into Shingrix, Zostavax, and SKYZoster. Zostavax, being a live, attenuated vaccine, has specific storage and handling requirements, which can be a drawback compared to the more convenient and effective Shingrix[4].

Financial Performance

Merck & Co., Inc., the manufacturer of Zostavax, has seen a mixed financial performance in recent years. While the company's overall pharmaceutical sales have grown, the decline in Zostavax sales has been a notable factor. For example, in 2018, Merck's pharmaceutical sales increased by 6%, but this growth was partially offset by declines in certain product lines, including virology products like Zostavax[2].

Revenue Impact

The revenue from Zostavax has been decreasing as Shingrix gains more market share. GSK's Shingrix, for instance, generated £3.4 billion in sales in 2023, highlighting the significant shift in market preference towards more effective vaccines[3].

Regulatory and Healthcare Policy Impact

Changes in healthcare policies and recommendations by health organizations have also impacted the sales of Zostavax. For example, the Centers for Disease Control and Prevention (CDC) recommends Shingrix as the preferred vaccine for preventing shingles, which has further reduced the demand for Zostavax.

Consumer and Healthcare Provider Preferences

Healthcare providers and consumers increasingly prefer vaccines with higher efficacy and longer-lasting protection. Shingrix offers a 90% efficacy rate in preventing shingles, significantly higher than Zostavax, which has led to a decline in Zostavax prescriptions[5].

Future Outlook

Given the current market dynamics, the future outlook for Zostavax appears challenging. The market is expected to continue growing, but the share of Zostavax is likely to decline further as newer, more effective vaccines dominate the market.

Key Takeaways

• Market Size and Growth: The global zoster vaccine market is growing, but Zostavax's share is declining.
• Competitive Landscape: Shingrix dominates the market due to its higher efficacy.
• Regional Performance: North America is the largest market, but Asia-Pacific is the fastest-growing.
• Product Segmentation: Zostavax faces challenges due to its live, attenuated nature.
• Financial Performance: Merck's overall sales growth is offset by declines in Zostavax sales.
• Regulatory Impact: Healthcare policy changes favor more effective vaccines like Shingrix.
• Consumer Preferences: Higher efficacy and longer-lasting protection drive preference for Shingrix.

FAQs

What is the current market size of the global zoster vaccine market?

The global zoster vaccine market was valued at USD 4.2 billion in 2023[1].

Which vaccine dominates the zoster vaccine market?

Shingrix dominates the market with around 42% market share due to its higher efficacy and longer-lasting protection[1].

What is the expected CAGR of the global zoster vaccine market from 2024 to 2033?

The market is expected to grow at a CAGR of 8.1% from 2024 to 2033[1].

Why is the demand for Zostavax declining?

The demand for Zostavax is declining due to the higher efficacy and longer-lasting protection offered by Shingrix, as well as changes in healthcare policy recommendations[3][5].

What are the key regions driving the growth of the zoster vaccine market?

North America is the largest market, but the Asia-Pacific region is expected to be the fastest-growing due to expanding healthcare infrastructure and increasing public awareness[4].

How has Merck's financial performance been affected by Zostavax sales?

Merck's overall pharmaceutical sales growth has been partially offset by declines in Zostavax sales, reflecting the market's preference for more effective vaccines[2].

Sources

1. The Brainy Insights - Zoster Vaccine Market Size, Share | CAGR of 8.1%
2. Merck - Merck Announces Fourth-Quarter and Full-Year 2018 Financial Results
3. GSK - Annual Report 2023
4. Straits Research - Global Shingles Vaccine Market Size, Top Share, Report to 2032
5. GlobeNewswire - Insights on the Shingles Vaccine Global Market to 2028