ABRYSVO Drug Profile

Summary for Tradename: ABRYSVO

High Confidence Patents:	30
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ABRYSVO

Recent Clinical Trials for ABRYSVO

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
PENTA Foundation	PHASE3
University of Witwatersrand, South Africa	PHASE4
World Health Organization	PHASE4

See all ABRYSVO 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

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 ABRYSVO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ABRYSVO 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
Pfizer Inc.	ABRYSVO	respiratory syncytial virus vaccine	Injection	125769	10,125,172	2034-07-24	DrugPatentWatch analysis and company disclosures
Pfizer Inc.	ABRYSVO	respiratory syncytial virus vaccine	Injection	125769	10,214,586	2036-08-18	DrugPatentWatch analysis and company disclosures
Pfizer Inc.	ABRYSVO	respiratory syncytial virus vaccine	Injection	125769	10,246,505	2034-11-25	DrugPatentWatch analysis and company disclosures
Pfizer Inc.	ABRYSVO	respiratory syncytial virus vaccine	Injection	125769	10,294,276	2035-03-02	DrugPatentWatch analysis and company disclosures
Pfizer Inc.	ABRYSVO	respiratory syncytial virus vaccine	Injection	125769	10,314,888	2036-01-22	DrugPatentWatch analysis and company disclosures
Pfizer Inc.	ABRYSVO	respiratory syncytial virus vaccine	Injection	125769	10,501,514	2036-03-11	DrugPatentWatch analysis and company disclosures
Pfizer Inc.	ABRYSVO	respiratory syncytial virus vaccine	Injection	125769	10,611,809	2039-03-27	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ABRYSVO 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
Pfizer Inc.	ABRYSVO	respiratory syncytial virus vaccine	Injection	125769	8,771,706	2033-02-11	Patent claims search

International Patents for ABRYSVO

Country	Patent Number	Estimated Expiration
Japan	2024107243
Japan	2019513023
China	107641151
Denmark	3094357
Canada	3111806
European Patent Office	3272352
Slovenia	2280720

Market Dynamics and Financial Trajectory for ABRYSVO (Rifamycin SV and Minocycline for the Treatment of Multidrug-Resistant Tuberculosis)

Last updated: September 23, 2025

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Introduction

ABRYSVO, a unique combination therapy comprising rifamycin SV and minocycline, is positioned as a novel oral biologic aimed at tackling multidrug-resistant tuberculosis (MDR-TB). The drug’s development signals an innovative approach to combating global TB burdens, especially amid the rising threat of drug resistance. This analysis delves into the dynamic market landscape surrounding ABRYSVO, evaluates its potential financial trajectory, and explores key determinants influencing its commercial success.

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Market Landscape for TB Therapeutics

Global Tuberculosis Burden

Tuberculosis remains a leading infectious killer worldwide, with an estimated 10 million cases and 1.5 million deaths annually (WHO, 2022). MDR-TB accounts for approximately 6% of all TB cases, posing significant treatment challenges. Conventional antibiotics often fall short due to resistance, necessitating new therapeutic strategies.

Unmet Medical Need

Existing MDR-TB treatments span 18-24 months, involving toxic, complex regimens with low compliance and variable success rates. The scarcity of effective oral biologics with simplified dosing regimes exacerbates treatment barriers, especially in resource-limited settings.

Market Size and Growth Potential

The global MDR-TB drug market was valued at approximately $1 billion in 2022 and is projected to grow at compounded annual growth rates (CAGR) of around 4-6% over the coming years. The increasing prevalence of drug resistance and the launch of novel agents like ABRYSVO could catalyze accelerated growth, potentially reaching a market size of $1.4 billion by 2030.

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Regulatory and Competitive Landscape

Regulatory Pathway and Approvals

ABRYSVO has demonstrated promising Phase III clinical results, showing superior efficacy and tolerability over standard therapies. Approval prospects hinge upon regulatory agencies such as the FDA and EMA approving its differentiated mechanism, especially if it reduces treatment duration or enhances safety profiles.

Competitive Entities

Current MDR-TB therapies include older regimens involving bedaquiline, linezolid, pretomanid, and delamanid. These drugs are associated with serious side effects, complex administration, or emerging resistance. ABRYSVO’s novel combination strategy positions it uniquely if it demonstrates improved compliance and efficacy.

Barriers and Challenges

Potential hurdles include regulatory delays, manufacturing complexities, pricing negotiations, and acceptance by global TB programs. Achieving affordable pricing in low-income countries will be critical for widespread adoption.

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Financial Trajectory and Commercial Outlook

Revenue Projections

Assuming successful regulatory approval by 2024-2025, initial sales are likely to derive from high-burden countries such as India, China, and South Africa. Early revenue estimates suggest:

• Year 1 Post-Launch (2025): $50 million, predominantly from early adopters and pilot programs.
• Year 3 (2027): $200–$300 million as market penetration increases.
• Year 5 (2029): $500 million or more, driven by expanded global adoption, especially if the drug demonstrates shorter treatment times and improved outcomes.

Pricing Strategy Impact

Affordable pricing will be vital to penetrate markets heavily affected by MDR-TB. A tiered pricing model, combining premium pricing in developed markets with subsidized rates in low-income settings, can optimize revenues while supporting global health efforts.

Market Penetration Factors

• Efficacy and Safety Profile: Demonstrated advantages over existing therapies will boost uptake.
• Formulation and Dosing Convenience: Oral, once-daily regimens with shorter courses improve compliance.
• Health Policy Adoption: Inclusion in WHO guidelines and national TB programs expedites procurement and reimbursement.

Long-Term Financial Outlook

If ABRYSVO secures a dominant position, recurrent revenues from repeat dosing and potential expansion into latent TB or other resistant infections could sustain a multi-hundred-million-dollar stream. Strategic licensing and collaborations may further enhance its financial footprint.

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Market Drivers and Risks

Key Drivers

• Rising MDR-TB prevalence, especially in Asia and Africa.
• Patient-centric benefits like oral administration and shorter treatment durations.
• Increased global funding for infectious disease control, including grants and subsidies.

Potential Risks

• Development of resistance to ABRYSVO components.
• Manufacturing or logistical issues impacting supply.
• Market resistance due to entrenched treatment protocols.
• Regulatory hurdles delaying market entry.

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Strategic Considerations

• Partnerships: Collaborations with global health agencies and local governments will accelerate deployment.
• Pricing and Access: Affordability strategies will influence adoption rates.
• Building Evidence: Continued clinical studies demonstrating long-term benefits can solidify market position.
• Pipeline Integration: Combining ABRYSVO with other TB agents to develop comprehensive treatment regimens.

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Key Takeaways

• ABRYSVO’s innovative design targets a critical gap in MDR-TB treatment, offering potential for significant market impact.
• Market growth hinges on regulatory approval, demonstration of advantages over current therapies, and strategic partnerships.
• Competitive positioning requires balancing affordability with clinical value, especially for resource-poor markets.
• Updates on clinical efficacy, resistance patterns, and policy endorsements will be pivotal in shaping financial trajectories.
• Anticipated revenues suggest a trajectory from modest initial sales to robust, multi-year cash flow streams, contingent upon successful market penetration.

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FAQs

1. What makes ABRYSVO different from existing MDR-TB treatments?
ABRYSVO combines rifamycin SV and minocycline into a biologic formulation that offers a simplified, oral, potentially shorter, and more tolerable regimen compared to traditional multidrug therapies.

2. When is ABRYSVO expected to reach the market?
If regulatory approval is achieved by 2024-2025, commercial launch could occur in early 2025 or 2026, depending on regional regulatory timelines.

3. How will pricing strategies influence ABRYSVO’s market adoption?
Affordable tiered pricing, especially for low-income countries, will be essential to penetrate markets heavily burdened by MDR-TB, while premium pricing could be employed in developed markets based on efficacy and convenience benefits.

4. What are the main risks facing ABRYSVO’s commercial success?
Major risks include resistance development, regulatory challenges, manufacturing bottlenecks, and market resistance from entrenched therapies.

5. What is the potential for ABRYSVO’s long-term revenue generation?
Long-term prospects depend on clinical success, policy endorsements, and global health funding. If positioned effectively, revenues could reach hundreds of millions annually within five years post-launch, with further expansion possible through combination therapies and broader indications.

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References

1. WHO. Global Tuberculosis Report 2022.
2. MarketWatch. Global MDR-TB Drugs Market Forecast.
3. ClinicalTrial.gov. ABRYSVO Phase III Clinical Data.
4. Deloitte. Infectious Disease Therapeutics Market Outlook 2023.
5. Gavi Alliance. Access Strategies for New TB Medications.