PNEUMOVAX 23 Drug Profile

Summary for Tradename: PNEUMOVAX 23

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for PNEUMOVAX 23
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PNEUMOVAX 23

Recent Clinical Trials for PNEUMOVAX 23

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sanofi	Phase 2
GPN Vaccines	Phase 1
Merck Sharp & Dohme Corp.	Phase 1/Phase 2

See all PNEUMOVAX 23 clinical trials

Recent Litigation for PNEUMOVAX 23

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.	2018-05-31

See all PNEUMOVAX 23 litigation

Pharmacology for PNEUMOVAX 23

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Pneumococcal Vaccine
Chemical Structure	Pneumococcal Vaccines Vaccines, Inactivated

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 PNEUMOVAX 23 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PNEUMOVAX 23 Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for PNEUMOVAX 23 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	PNEUMOVAX 23	pneumococcal vaccine, polyvalent	Injection	101094	10,391,160	2034-03-14	Patent claims search
Merck Sharp & Dohme Llc	PNEUMOVAX 23	pneumococcal vaccine, polyvalent	Injection	101094	10,555,993	2034-03-14	Patent claims search
Merck Sharp & Dohme Llc	PNEUMOVAX 23	pneumococcal vaccine, polyvalent	Injection	101094	10,994,003	2039-12-30	Patent claims search

PNEUMOVAX 23 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PNEUMOVAX 23

Introduction to PNEUMOVAX 23

PNEUMOVAX 23 is a pneumococcal polysaccharide vaccine developed by Merck & Co., Inc. It is designed to protect against 23 serotypes of Streptococcus pneumoniae, a bacteria that can cause serious infections such as pneumonia, meningitis, and sepsis. Here’s a detailed look at the market dynamics and financial trajectory of PNEUMOVAX 23.

Market Size and Growth

The global pneumococcal vaccine market, which includes PNEUMOVAX 23, was estimated to be around USD 8.07 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.21% from 2024 to 2030, reaching USD 12.19 billion by 2030[4].

Segmentation and Market Share

The pneumococcal vaccine market is segmented by vaccine type, age group, end user, and region. PNEUMOVAX 23 falls under the pneumococcal polysaccharide vaccine category. While pneumococcal conjugate vaccines, such as Prevnar 13 and the newly approved Prevnar 20, dominate the market due to their broader use in children and adults, PNEUMOVAX 23 still holds a significant share, particularly among older adults[1][4].

Growth Drivers

• Government Initiatives and Awareness: Government health agencies and organizations actively promote vaccination campaigns, which drive the demand for pneumococcal vaccines, including PNEUMOVAX 23. For instance, the high burden of pneumonia globally, with around 2,000 children affected daily, underscores the need for these vaccines[3].
• Established Healthcare Infrastructure: In regions like North America, the well-established healthcare infrastructure supports the distribution and administration of vaccines like PNEUMOVAX 23, contributing to its market share[4].

Challenges and Decline

• Shift to Conjugate Vaccines: The market is witnessing a shift towards pneumococcal conjugate vaccines, such as Prevnar 13 and Prevnar 20, which offer broader serotype coverage and are preferred for their ability to provide immune response in younger populations. This shift has led to a decline in the sales of PNEUMOVAX 23[5].
• Side Effects and Limitations: PNEUMOVAX 23, like other polysaccharide vaccines, has limitations in terms of immune response and potential side effects, which can hinder its adoption compared to conjugate vaccines[1].

Financial Performance

• Revenue Trends: Merck & Co., Inc. reported lower sales of PNEUMOVAX 23 in 2023, as the market continues to shift towards newer adult pneumococcal conjugate vaccines. This decline is part of a broader trend where pharmaceutical sales growth is driven more by newer vaccines and other product lines[5].
• Full-Year 2023 Results: Merck's full-year 2023 pharmaceutical sales grew 3% to $53.6 billion, but this growth was partially offset by lower sales of PNEUMOVAX 23 and other products facing generic competition or declining demand[5].

Regional Performance

• North America: This region dominates the pneumococcal vaccine market, including PNEUMOVAX 23, due to its well-established healthcare infrastructure and high awareness of vaccination importance. However, the shift towards conjugate vaccines is more pronounced here, affecting PNEUMOVAX 23's market share[4].

Competitive Landscape

The pneumococcal vaccine market is highly competitive, with key players like Pfizer Inc., Merck & Co., Inc., GSK plc, Sanofi, and others. The recent approvals and developments of newer conjugate vaccines, such as Pfizer's Prevnar 20 and Sanofi's 21-valent conjugate vaccine candidate, further intensify the competition and contribute to the decline in PNEUMOVAX 23's market share[4].

Future Outlook

While PNEUMOVAX 23 will continue to be used, especially among older adults where it remains a viable option, its market share is expected to decline as newer conjugate vaccines gain more acceptance and approval. The overall pneumococcal vaccine market, however, is expected to grow driven by increasing prevalence of target diseases, rising awareness, and favorable government initiatives[3][4].

Key Takeaways

• Market Shift: The pneumococcal vaccine market is shifting towards conjugate vaccines, impacting PNEUMOVAX 23's sales.
• Government Initiatives: Government promotion of vaccination campaigns continues to drive demand for pneumococcal vaccines.
• Regional Dominance: North America remains a significant market for pneumococcal vaccines, including PNEUMOVAX 23.
• Competitive Landscape: The market is highly competitive with newer vaccine developments affecting PNEUMOVAX 23's market share.

FAQs

1. What is PNEUMOVAX 23 used for? PNEUMOVAX 23 is a pneumococcal polysaccharide vaccine used to protect against 23 serotypes of Streptococcus pneumoniae, which can cause serious infections like pneumonia, meningitis, and sepsis.

2. Why is the market share of PNEUMOVAX 23 declining? The market share of PNEUMOVAX 23 is declining due to the shift towards pneumococcal conjugate vaccines, such as Prevnar 13 and Prevnar 20, which offer broader serotype coverage and are preferred for their immune response in younger populations.

3. What are the key growth drivers for the pneumococcal vaccine market? Key growth drivers include government initiatives and awareness campaigns, the high prevalence of pneumonia, and the introduction of new pneumococcal vaccines.

4. Which regions dominate the pneumococcal vaccine market? North America dominates the pneumococcal vaccine market due to its well-established healthcare infrastructure and high awareness of vaccination importance.

5. Who are the key players in the pneumococcal vaccine market? Key players include Pfizer Inc., Merck & Co., Inc., GSK plc, Sanofi, and others.

Cited Sources

1. Research Nester: Pneumococcal Vaccine Market Size & Share, Growth Report 2036[1]
2. Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance[2]
3. Mordor Intelligence: Pneumococcal Vaccine Market Size & Share Analysis[3]
4. Grand View Research: Pneumococcal Vaccine Market Size And Share Report, 2030[4]
5. Merck: Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results[5]