You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 10, 2025

SHINGRIX Drug Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Tradename: SHINGRIX
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for SHINGRIX
Recent Clinical Trials for SHINGRIX

Identify potential brand extensions & biosimilar entrants

SponsorPhase
GlaxoSmithKlinePhase 2
University of Colorado, DenverPhase 2
Columbia UniversityPhase 4

See all SHINGRIX clinical trials

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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 SHINGRIX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: SHINGRIX

Introduction

SHINGRIX, developed by GlaxoSmithKline (GSK), is a highly successful shingles vaccine that has significantly impacted the pharmaceutical market. Here, we will delve into the market dynamics and financial trajectory of SHINGRIX, exploring its performance, challenges, and future prospects.

Market Performance of SHINGRIX

Global Demand and Sales

SHINGRIX has been a top-selling vaccine for GSK, with its sales driven by strong demand globally. In the first quarter of 2024, SHINGRIX generated £945 million in sales, with half of the worldwide sales coming from markets outside the U.S.[1].

International Growth

The vaccine has seen substantial growth in international markets, particularly in Europe and other regions. This international demand has been a key factor in offsetting the decline in U.S. sales, which have been affected by changes in Medicare Part D and the prioritization of flu and COVID-19 vaccines[1][4].

Financial Performance

Quarterly Sales

In the second quarter of 2024, SHINGRIX sales were £832 million, down from the first quarter but still up year-to-date. This decline was attributed to channel inventory reductions, changes in retail vaccine prioritization, and lower demand in the U.S.[4][5].

Annual Projections

Despite the quarterly decline, GSK expects SHINGRIX sales to eventually climb to more than $4 billion annually, driven by its introduction in countries other than the U.S.[4].

Market Dynamics

Seasonality

SHINGRIX sales are influenced by seasonal patterns. Vaccinations are more common in the summer and early fall, leading to higher sales during these periods. However, sales tend to decline in the second quarter due to lower demand during the spring[1][4].

Competition and Market Share

SHINGRIX faces competition in the shingles vaccine market, but it remains a dominant player. The vaccine's success is partly due to its high efficacy and strong market penetration. However, GSK faces challenges in convincing harder-to-reach adults in the U.S. to get vaccinated, with only about 37% of the over 120 million U.S. adults recommended for SHINGRIX having been vaccinated[4].

Regulatory and Expansion Efforts

Regulatory Approvals

GSK is working to expand the use of SHINGRIX to younger adults. Currently, the vaccine is cleared for use in people aged 60 and above, but the company is seeking regulatory approval to include adults between the ages of 50 and 59. An FDA decision on this expansion is expected by June 7, 2024[1].

Public Immunization Programs

New public immunization programs in Europe and other international markets have significantly boosted SHINGRIX sales. These programs have helped increase vaccination rates and drive revenue for GSK[1].

Financial Outlook and Guidance

Revised Forecasts

GSK has revised its financial forecasts for 2024, reflecting both the strong performance of SHINGRIX and the challenges faced. The company now expects its overall sales to grow between 7% and 9%, with core operating profit and core EPS increasing by 11% to 13% and 10% to 12%, respectively[2][4].

Segment Performance

While vaccine sales, including SHINGRIX, have shown mixed results, other segments such as specialty medicines (including HIV medications) and general medicines have performed strongly. This broad-based performance has helped GSK maintain its financial growth trajectory[2][5].

Challenges and Future Prospects

Inventory and Retail Prioritization

SHINGRIX sales have been impacted by inventory changes and shifts in retail vaccine prioritization in the U.S. These factors have led to a decline in U.S. sales, despite strong international growth[4].

CDC Recommendations

The Centers for Disease Control and Prevention (CDC) have adjusted their recommendations to focus more strongly on adults aged 75 years or older for RSV vaccines, but not yet for SHINGRIX. This could influence future vaccination rates and sales[4].

Conclusion

SHINGRIX has been a cornerstone of GSK's vaccine portfolio, driving significant revenue and growth. Despite facing challenges such as seasonality, inventory changes, and retail prioritization, the vaccine is expected to continue its strong performance globally.

Key Takeaways

  • Global Sales: SHINGRIX has generated substantial sales globally, with half of its sales coming from markets outside the U.S.
  • International Growth: Strong demand in Europe and other regions has offset declines in U.S. sales.
  • Seasonality: Sales are influenced by seasonal patterns, with higher sales in summer and early fall.
  • Regulatory Expansion: GSK is seeking approval to expand SHINGRIX use to younger adults.
  • Financial Outlook: GSK has revised its forecasts, expecting overall sales and core operating profit to grow significantly.

FAQs

Q: What are the primary drivers of SHINGRIX sales?

A: The primary drivers of SHINGRIX sales include strong demand in international markets, particularly in Europe, and new public immunization programs.

Q: How has seasonality affected SHINGRIX sales?

A: SHINGRIX sales are higher in the summer and early fall due to vaccination patterns, but decline in the second quarter due to lower demand during the spring.

Q: What are the challenges faced by SHINGRIX in the U.S. market?

A: SHINGRIX faces challenges in the U.S. due to inventory changes, shifts in retail vaccine prioritization, and lower demand among harder-to-reach adults.

Q: What are GSK's plans for expanding SHINGRIX use?

A: GSK is seeking regulatory approval to expand SHINGRIX use to adults between the ages of 50 and 59, with an FDA decision expected by June 7, 2024.

Q: How does SHINGRIX contribute to GSK's overall financial performance?

A: SHINGRIX is a key contributor to GSK's financial performance, with its sales helping to drive overall revenue and growth, despite mixed results in the vaccine segment.

Sources

  1. Biopharma Dive - GSK raises forecasts on strong vaccine, HIV drug sales
  2. MMM Online - GSK raises outlook amid mixed vaccine results, Shingrix sales dip
  3. SkyQuest - Shingles Vaccine Market Growth, Size & Share Analysis | 2031
  4. Biopharma Dive - GSK cuts vaccine forecasts, while predicting faster overall growth
  5. GSK - Q2 2024 Results Announcement

More… ↓

⤷  Free Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.