UZEDY Drug Patent Profile

When do Uzedy patents expire, and what generic alternatives are available?

Uzedy is a drug marketed by Teva and is included in one NDA. There are twelve patents protecting this drug.

This drug has ninety-nine patent family members in thirty-five countries.

The generic ingredient in UZEDY is risperidone. There are thirty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Uzedy

A generic version of UZEDY was approved as risperidone by RISING on October 8^th, 2008.

Summary for UZEDY

International Patents:	99
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for UZEDY
What excipients (inactive ingredients) are in UZEDY?	UZEDY excipients list
DailyMed Link:	UZEDY at DailyMed

See drug prices for UZEDY

Pharmacology for UZEDY

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for UZEDY

UZEDY is protected by fifteen US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-005	Apr 28, 2023		RX	Yes	Yes			Y
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-002	Apr 28, 2023		RX	Yes	Yes
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-006	Apr 28, 2023		RX	Yes	Yes			Y
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-004	Apr 28, 2023		RX	Yes	Yes

Expired US Patents for UZEDY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-006	Apr 28, 2023
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-007	Apr 28, 2023
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-006	Apr 28, 2023
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-005	Apr 28, 2023

EU/EMA Drug Approvals for UZEDY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Laboratorios Farmacéuticos Rovi, S.A.	Okedi	risperidone	EMEA/H/C/005406Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.	Authorised	no	no	no	2022-02-14

International Patents for UZEDY

See the table below for patents covering UZEDY around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5631811
European Patent Office	3586825
Brazil	112022004535	Formulações de entrega de fármaco
South Africa	201304687	BIODEGRADABLE DRUG DELIVERY COMPOSITIONS

Supplementary Protection Certificates for UZEDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0196132	94C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: UZEDY

Last updated: July 28, 2025

---

Introduction

UZEDY (sotrovimab) is a monoclonal antibody developed for treating COVID-19. As an essential component of pandemic management strategies, UZEDY's market performance is shaped by the evolving landscape of infectious disease therapeutics, regulatory frameworks, and competitive pressures. This analysis examines the current market dynamics influencing UZEDY's commercial trajectory and evaluates its financial outlook amid the shifting pharmaceutical environment.

---

Regulatory Background and Approval Timeline

UZEDY received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in May 2021, primarily targeting high-risk COVID-19 patients. Subsequent regulatory decisions, including full approval processes, impact market adoption rates and reimbursement pathways. The product’s prior EUA status has been refreshed periodically, reflecting ongoing clinical data assessments and variant considerations, notably the Omicron variant's emergence, which affected monoclonal antibody efficacy.

Regulatory flexibility during the pandemic accelerated UZEDY’s market entry but also introduced uncertainty concerning its long-term positioning, especially as regulators in other jurisdictions evaluate variant-specific efficacy and authorize alternative therapeutics.

---

Market Demand Drivers

Pandemic Evolution and Variant Prevalence

The necessity for monoclonal antibody therapeutics like UZEDY has been closely linked to COVID-19 case surges. The emergence of variants, particularly Omicron, challenged UZEDY’s efficacy due to mutations affecting binding affinity. Regulatory agencies responded by restricting use or issuing updated guidance, directly impacting demand.

Therapeutic Positioning and Clinical Efficacy

UZEDY demonstrated strong efficacy in early clinical trials, reducing hospitalization and severe outcomes. However, real-world effectiveness varies with circulating variants, influencing prescriber confidence and adoption rates. The evolving therapeutic landscape, including oral antiviral agents like Paxlovid (Pfizer) and Molnupiravir (Merck), further reshapes demand dynamics.

Competitive Landscape

The market is saturated with monoclonal antibodies, including Eli Lilly's bamlanivimab, Regeneron’s casirivimab/imdevimab, and others. The limited activity of UZEDY against certain variants necessitates continuous development, boosting the importance of next-generation antibodies or combination therapies to maintain market relevance.

Pandemic Outlook and Vaccination Rates

High global vaccination rates and booster campaigns reduce the overall burden of severe COVID-19, leading to decreased demand for therapeutic interventions. However, vulnerable populations and regions with low vaccination coverage sustain unmet needs, providing niche market opportunities for UZEDY.

---

Pharmaceutical Market Dynamics

Pricing and Reimbursement Policies

Initially priced attractively, UZEDY's reimbursement landscape hinges on healthcare system acceptance, cost-effectiveness analyses, and evidence of clinical benefit. Payer policies increasingly favor oral antivirals due to ease of administration, exerting downward pressure on monoclonal antibody pricing.

Supply Chain and Manufacturing Capacity

Manufacturing scalability has proven vital during the pandemic. UZEDY’s production has faced challenges, including supply chain disruptions and the need for cold chain logistics. Efficient production expansion and partnerships influence availability and, consequently, revenues.

Global Distribution and Access

Distribution rights extend through collaborations with international health bodies and regional pharmaceutical companies. US markets dominate sales; however, access in low-resource settings remains limited due to high costs and logistical hurdles, affecting overall market size.

---

Financial Trajectory Analysis

Revenue Projections

While initial sales surged during the early pandemic phases, subsequent decline has been observed due to variant resistance and competition. Analysts project a phased decline in revenue over the next 2-3 years, unless new indications or formulations are pursued.

R&D and Pipeline Potential

Investment in next-generation monoclonal antibodies targeting emerging variants is critical. Success in developing broadly neutralizing antibodies or combination therapies could revive sales momentum. Partnerships with biotech firms and government agencies may accelerate development, impacting future revenues.

Pricing Strategies and Market Penetration

Premium pricing persists in the absence of alternatives; however, market penetration is governed by regulatory approvals and clinical positioning. The shift towards oral antivirals could erode profit margins unless UZEDY is positioned as part of combination regimens or for specific high-risk groups.

Impact of Regulatory Developments

Reconsideration by agencies regarding EUA status or full approval influences revenue streams. As clinical data accumulates, potential for expanded indications (e.g., post-exposure prophylaxis) could diversify revenue sources.

---

Future Outlook and Market Trends

Emergence of Next-Generation Therapeutics

The focus on pan-coronavirus therapies and next-generation monoclonal antibodies aims to address resistance issues. Successful development of such drugs could diminish UZEDY’s relevance unless strategically repositioned.

Integration with COVID-19 Management Strategies

Efforts to embed antibody therapies into outpatient treatment protocols for high-risk populations sustain some demand. Market penetration in hospital and post-exposure settings influences financial performance.

Global Market Expansion

Emerging markets exhibit growing demand for COVID-19 therapeutics, contingent on approval and affordability. UZEDY’s market trajectory depends on Indian and Chinese regulatory pathways, manufacturing capacity, and pricing strategies.

---

Key Takeaways

• Demand is volatile: Fluctuations in variant prevalence and evolving clinical efficacy data significantly impact UZEDY’s market potential.
• Competitive pressure is intensifying: The rise of oral antivirals and next-generation antibodies necessitates strategic repositioning and innovation to sustain sales.
• Regulatory environment is pivotal: Approvals and re-evaluations directly influence access, reimbursement, and revenue streams.
• Manufacturing scalability is essential: Enhanced production capacity is critical to meet demand surges and improve global access.
• Industry dynamics favor diversification: Future growth depends on expanding indications, pursuing pipeline innovation, and entering new markets.

---

Conclusion

UZEDY's market dynamics and financial prospects are intertwined with the ongoing evolution of COVID-19 therapeutics. While initial demand was propelled by urgent pandemic needs, the drug now faces challenges from emerging variants, competitive oral treatments, and changing healthcare priorities. Strategic investments in pipeline development and global access initiatives will determine its long-term financial trajectory.

---

FAQs

1. How has the emergence of COVID-19 variants affected UZEDY’s market potential?
The effectiveness of UZEDY varies with circulating variants; notably, Omicron significantly reduced its efficacy, prompting regulatory restrictions and diminishing demand in some markets.

2. What competitive therapies threaten UZEDY’s market share?
Oral antivirals like Pfizer’s Paxlovid and Merck’s Molnupiravir offer easier administration and broad-spectrum efficacy, challenging monoclonal antibodies including UZEDY.

3. What strategic moves could sustain UZEDY’s financial performance?
Developing next-generation broad-spectrum antibodies, securing expanded regulatory approvals, exploring additional indications, and expanding global access can enhance its market longevity.

4. How does pricing influence UZEDY’s adoption in different regions?
High prices limit access in low-income countries, whereas reimbursement policies and government procurement strategies in high-income settings mitigate this barrier, affecting overall sales.

5. What are the prospects for UZEDY’s pipeline and long-term viability?
Progress in pipeline innovation—such as pan-coronavirus antibodies—and potential new indications could revitalize its market positioning, contingent upon successful R&D and regulatory approval.

---

Sources:

[1] FDA. (2021). Emergency Use Authorization for Sotrovimab.
[2] CDC. (2022). COVID-19 Treatment Guidelines.
[3] Statista. (2023). COVID-19 therapeutic market analysis.
[4] Pfizer. (2022). Paxlovid clinical efficacy data.
[5] Merck. (2022). Molnupiravir approval and usage.