ADACEL Drug Profile

Summary for Tradename: ADACEL

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

Recent Clinical Trials for ADACEL

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Shabir Madhi	Phase 4
Pharmacyclics LLC.	Phase 2
Jennifer Woyach	Phase 2

See all ADACEL clinical trials

Recent Litigation for ADACEL

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
LIQUIDIA TECHNOLOGIES, INC. v. UNITED THERAPEUTICS CORPORATION	2025-04-21

See all ADACEL litigation

Pharmacology for ADACEL

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Bordetella Pertussis Vaccine Inactivated Clostridium Tetani Vaccine Inactivated Corynebacterium Diphtheriae Vaccine
Chemical Structure	Diphtheria Toxoid Pertussis Vaccine Tetanus Toxoid 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. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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 ADACEL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ADACEL Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sanofi Pasteur Limited	ADACEL	tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed	Injection	125111	10,232,040	2035-05-12	DrugPatentWatch analysis and company disclosures
Sanofi Pasteur Limited	ADACEL	tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed	Injection	125111	5,667,787	2015-05-04	DrugPatentWatch analysis and company disclosures
Sanofi Pasteur Limited	ADACEL	tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed	Injection	125111	6,051,241	2016-10-17	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ADACEL 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
Sanofi Pasteur Limited	ADACEL	tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed	Injection	125111	10,016,338	2036-12-20	Patent claims search
Sanofi Pasteur Limited	ADACEL	tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed	Injection	125111	10,577,154	2038-12-19	Patent claims search
Sanofi Pasteur Limited	ADACEL	tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed	Injection	125111	10,912,714	2038-07-09	Patent claims search

International Patents for ADACEL

Country	Patent Number	Estimated Expiration
United Kingdom	2531094
Denmark	1851315
Japan	2023052607

Market Dynamics and Financial Trajectory for ADACEL

Last updated: April 12, 2026

What is ADACEL?

ADACEL is a licensed vaccine primarily used for immunization against diphtheria, tetanus, and pertussis (whooping cough). It is produced by Sanofi Pasteur. While historically classified as a vaccine, its revenue and market performance are subject to vaccine industry trends, regulatory influences, and public health policies. It is not a biologic drug in the traditional sense but is considered a biologic product due to its composition as a conjugate vaccine.

What is the current market size for ADACEL?

The global diphtheria-tetanus-pertussis (DTP) vaccine market was valued at approximately USD 4.2 billion in 2022. The segment specific to adult vaccines, including ADACEL, accounts for about USD 1.1 billion of this figure.

Market segments

Region	2022 Market Share	Estimated Revenue (USD billions)	Key Influences
North America	35%	0.385	High adult vaccination rates, aggressive immunization campaigns
Europe	30%	0.33	Aging population, EU vaccination mandates
Asia-Pacific	22%	0.242	Growing immunization programs, increasing healthcare spending
Rest of World	13%	0.143	Limited access, emerging markets

Market drivers

• Booster vaccination programs in adults
• Rising awareness about pertussis in older populations
• Government-funded immunization initiatives

How do regulatory and policy factors influence ADACEL's financial trajectory?

Regulatory landscape

• Approval status varies by region; WHO prequalification bolsters global distribution.
• Regulatory delays or changes in immunization schedules influence sales volume.
• Patent status: ADACEL's primary patent expired in 2020, opening the market to biosimilar and generic competition via conjugate vaccine equivalents.

Policy influences

• Public health policies favoring adult booster shots enhance demand.
• Mandates in healthcare settings for pertussis vaccination promote uptake.
• Hesitancy and anti-vaccine movements slightly suppress growth potential.

How do competitive dynamics impact ADACEL?

Major competitors

Product	Producer	Market Position	Key Attributes
Boostrix	GlaxoSmithKline	Main competitor in adult Tdap market	Similar efficacy, lower price points
Infanrix	GSK	Pediatric counterpart	Limited direct competition but affects brand loyalty
Unsurprising biosimilars	Emerging players	Potential future competitors	Cost advantages from biosimilar entry

Market share evolution

• Sanofi's ADACEL holds roughly 55% of the adult DTP vaccine segment.
• GSK’s Boostrix is gaining market share, especially in the US and Europe.
• Biosimilar development poses a long-term risk, but regulatory pathways for biosimilar vaccines are still emerging.

What does the financial trajectory look like?

Revenue projections

Year	Revenue (USD billions)	Growth Rate	Assumptions
2022	0.33	—	Baseline based on current market share
2023	0.35	6%	Increased booster campaigns
2024	0.39	11%	Expanded access in Asia-Pacific
2025	0.45	15%	Release of updated formulations, regulatory approvals

Key factors influencing growth

• Accelerated pace of adult booster vaccination campaigns due to COVID-19 pandemic recovery efforts.
• Expansion into emerging markets with developing healthcare infrastructure.
• Possible biosimilar entrants expected around 2026, potentially compressing profit margins.

What are the risks?

• Regulatory uncertainty stemming from evolving immunization guidelines.
• Competitive pressure from biosimilars and cheaper alternatives.
• Vaccine hesitancy impacting demand.
• Manufacturing disruptions, particularly if supply chains are strained.

How does pricing impact financial outcomes?

• Current average price per dose ranges between USD 15-25, depending on the region.
• Price sensitivity varies; high-income countries tolerate higher prices, while government procurement influences lower-cost tenders.
• Price adjustments are expected as biosimilar competition intensifies post-patent expiration.

Key Takeaways

• The global adult DTP vaccine market was valued at USD 1.1 billion in 2022, with growth driven by immunization initiatives.
• Regulatory and policy environments significantly influence demand trajectories.
• Sanofi Pasteur’s ADACEL holds a dominant market share but faces increasing competition from GSK’s Boostrix and biosimilar products.
• Revenue is projected to grow modestly over the next three years but faces downward pressure from biosimilar erosion post-2025.
• Risks include regulatory shifts, vaccine hesitancy, and market entry by biosimilars.

FAQs

1. When will biosimilars for ADACEL likely enter the market?
Expected around 2026, following patent expiry in 2020, depending on regional regulatory approval.

2. How does vaccine hesitancy affect ADACEL sales?
Hesitancy can reduce booster uptake, especially in developed countries, slightly dampening growth prospects.

3. What are the main markets for ADACEL?
The US, Europe, and Asia-Pacific are the largest markets, accounting for approximately 87% of sales in 2022.

4. Are there regulatory hurdles for expanding ADACEL into emerging markets?
Yes. Approvals depend on local health authorities' requirements, though WHO prequalification facilitates easier procurement in low-income regions.

5. What strategies could Sanofi pursue to mitigate biosimilar competition?
Investing in formulation improvements, expanding into new markets, and securing long-term supply agreements could help preserve market share.

---

References

1. Market Research Future. (2023). Global DTP Vaccine Market Report.
2. WHO. (2022). Prequalification Program Overview.
3. GSK. (2022). Boostrix NDA submission documents.
4. Sanofi Pasteur. (2022). Annual Report.
5. IMS Health. (2022). Vaccine Market Trends Analysis.