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 ten patents protecting this drug.

This drug has eighty-six patent family members in thirty-four countries.

The generic ingredient in UZEDY is risperidone. There are thirty drug master file entries for this compound. Thirty-six 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 APOTEX INC on September 15^th, 2008.

Summary for UZEDY

International Patents:	86
US Patents:	10
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 ten 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	213586-003	Apr 28, 2023		RX	Yes	Yes	9,895,447		Y
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-004	Apr 28, 2023		RX	Yes	Yes	9,925,268		Y
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-005	Apr 28, 2023		RX	Yes	Yes	8,802,127		Y
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-006	Apr 28, 2023		RX	Yes	Yes	10,736,965		Y
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-007	Apr 28, 2023		RX	Yes	Yes	9,023,897		Y

Expired US Patents for UZEDY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-005	Apr 28, 2023	9,895,447
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-003	Apr 28, 2023	10,736,965
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-002	Apr 28, 2023	9,439,905
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-006	Apr 28, 2023	9,717,799
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-007	Apr 28, 2023	9,439,905

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/005406 Treatment 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
Cuba	24203	COMPOSICIONES DE SUMINISTRO DE FÁRMACOS BIODEGRADABLES
Eurasian Patent Organization	201390783	БИОРАЗЛАГАЕМЫЕ КОМПОЗИЦИИ ДЛЯ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ
European Patent Office	2658525	COMPOSITIONS BIODÉGRADABLES D'ADMINISTRATION DE MÉDICAMENTS (BIODEGRADABLE DRUG DELIVERY COMPOSITIONS)
Mexico	2008000573	IMPLANTES QUE CONTIENEN FARMACOS Y METODOS DE USO DE LOS MISMOS. (DRUG-CONTAINING IMPLANTS AND METHODS OF USE THEREOF.)
South Korea	101242486

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 UZEDY

Introduction

UZEDY, a long-acting injectable formulation of risperidone, has been making significant waves in the antipsychotic drugs market since its launch. Here, we delve into the market dynamics and financial trajectory of UZEDY, highlighting its growth, market impact, and future prospects.

Market Context

The global antipsychotic drugs market is experiencing robust growth, driven by the increasing prevalence of mental health disorders. The U.S. antipsychotic drugs market, in particular, was valued at $7.49 billion in 2022 and is projected to grow at a CAGR of 6.4% during the forecast period[1].

Product Overview

UZEDY is developed by Medincell and commercialized by Teva Pharmaceuticals. It is administered as a subcutaneous injection every one or two months, utilizing a pre-filled syringe. This formulation has shown promising results in managing schizophrenia in adults, with recent phase 3 trials validating its efficacy and safety[4].

Sales Performance

Since its launch, UZEDY has demonstrated strong sales performance. Here are some key financial highlights:

• Revenue Growth: As of Q3 2024, UZEDY's U.S. revenues year-to-date have reached $75 million, with $35 million generated in the third quarter alone. This performance has led to an upward revision of the 2024 sales forecast from $80 million to $100 million[2][5].
• Royalties: Medincell has invoiced €2.8 million in royalties based on UZEDY's net sales in the United States during the first half of the 2024-2025 fiscal year[5].

Market Impact

UZEDY's success can be attributed to several factors:

• Efficacy and Safety: The drug has shown positive efficacy results in clinical trials, including the phase 3 RISE study published in The Lancet Psychiatry. No cases of post-injection delirium/sedation syndrome (PDSS) were observed after 100% of the targeted injections, which is a significant safety milestone[4][5].
• Convenience: The long-acting injectable formulation makes it easier for patients to adhere to their treatment regimens, as it reduces the frequency of injections compared to traditional oral medications.
• Regulatory Approval: UZEDY received FDA approval in April 2023 for the management of schizophrenia in adults, which has been a crucial factor in its market acceptance[4].

Competitive Landscape

The antipsychotic drugs market is semi-consolidated, with major players like Otsuka Pharmaceutical Co. Ltd. and Janssen Global Services LLC dominating the market. However, UZEDY's unique formulation and strong clinical data have positioned it as a significant competitor in the long-acting injectable segment[1].

Future Prospects

Several factors indicate a promising future for UZEDY:

• Expanded Indications: While currently approved for schizophrenia, there is potential for UZEDY to be explored for other psychiatric conditions, further expanding its market reach.
• Strategic Partnerships: Medincell's strategic co-development and licensing agreements, such as the one with AbbVie, are expected to drive innovation and growth in the company's product portfolio[5].
• Financial Projections: With a revised sales forecast of $100 million for 2024, UZEDY is on track to contribute significantly to Medincell's revenue growth. The company anticipates a 2- to 3-fold increase in revenue and a significant improvement in operating profit by the end of the fiscal year[5].

Key Milestones

• Clinical Trials: The completion of the pivotal phase 3 trial for UZEDY without any cases of PDSS is a critical milestone. The submission of the U.S. marketing application for Olanzapine Long-Acting Injectable (mdc-TJK) is expected in the first half of 2025[5].
• Financial Performance: Medincell's revenue has already reached 95% of the total revenue from the previous year, highlighting the company's strong momentum in 2024[5].

Conclusion

UZEDY has established itself as a significant player in the antipsychotic drugs market, particularly in the long-acting injectable segment. Its strong sales performance, positive clinical data, and strategic partnerships position it for continued growth and market dominance.

Key Takeaways

• UZEDY's U.S. revenues are projected to reach $100 million in 2024.
• The drug has shown strong efficacy and safety in clinical trials.
• Medincell's strategic partnerships are driving innovation and revenue growth.
• UZEDY is expected to contribute significantly to Medincell's financial performance.

FAQs

1. What is UZEDY and how is it administered? UZEDY is a long-acting injectable formulation of risperidone, administered as a subcutaneous injection every one or two months using a pre-filled syringe.

2. What are the key financial highlights for UZEDY in 2024? As of Q3 2024, UZEDY's U.S. revenues year-to-date have reached $75 million, with a revised sales forecast of $100 million for the year.

3. What are the safety and efficacy results for UZEDY? UZEDY has shown positive efficacy results in clinical trials, including the phase 3 RISE study, and no cases of post-injection delirium/sedation syndrome (PDSS) were observed after 100% of the targeted injections.

4. Who are the major players in the antipsychotic drugs market? The market is dominated by companies like Otsuka Pharmaceutical Co. Ltd. and Janssen Global Services LLC, but UZEDY is a significant competitor in the long-acting injectable segment.

5. What are the future prospects for UZEDY? UZEDY is expected to expand its market reach through potential new indications, strategic partnerships, and continued strong financial performance.

Sources

1. Fortune Business Insights - U.S. Antipsychotic Drugs Market Size, Share | Growth [2030]
2. Business Wire - Medincell: 25% Raise in 2024 UZEDY® Revenue Outlook & Key Milestone Reached for Olanzapine LAI Clinical Phase 3
3. Fortune Business Insights - Antipsychotic Drugs Market Size, Share | Growth [2024-2032]
4. Knowledge Sourcing - Antipsychotic Drugs Market Size: Industry Report, 2024-2029
5. Business Wire - Medincell Publishes Its Consolidated Half-year Financial Results