UZEDY Drug Patent Profile

Which patents cover Uzedy, 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

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

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
South Korea	101283946
Serbia	56550	BIORAZGRADIVI SASTAVI ZA ISPORUKU LEKOVA (BIODEGRADABLE DRUG DELIVERY COMPOSITIONS)
Canada	3208006

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: December 30, 2025

Summary

UZEDY (sacitizumab govitecan-hziy) is a notable therapeutic agent developed by Sierra Oncology (a subsidiary of GSK) for the treatment of metastatic triple-negative breast cancer (mTNBC). Approved by the U.S. Food and Drug Administration (FDA) in April 2023, UZEDY marks a significant advancement in targeted chemotherapy, harnessing antibody-drug conjugate (ADC) technology. This analysis explores the evolving market landscape, projected financial performance, competitive positioning, and regulatory influences shaping UZEDY’s commercial trajectory.

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What Are UZEDY’s Market Opportunities and Challenges?

Market Overview and Indication Scope

Parameter	Details
Approved Indication	Treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have previously received at least two prior therapies for metastatic disease.
Market Size (Global, 2023)	Estimated at approximately $1.8 billion, driven by rising incidence of breast cancer and lack of targeted therapies for mTNBC. (Source: Global Data, 2023)
U.S. Market Potential (2023-2030)	Projected to reach $1.2 billion, with CAGR of 12%, driven by expanded indications and increased diagnostic accuracy.

Key Drivers of Market Dynamics

Driver	Impact & Rationale
Unmet Medical Need	Limited targeted options for mTNBC elevate demand for UZEDY’s novel ADC approach.
Regulatory Approvals & Expansions	Potential for label expansion to earlier lines of therapy and combination regimens.
Competitive Landscape	Competition from existing therapies (e.g., sacituzumab govitecan, enfortumab vedotin, pembrolizumab). has grown, necessitating differentiation of UZEDY.
Diagnostic Advancements	Increased adoption of biomarker testing (e.g., TROP-2 expression) enhances patient selection and market penetration.
Reimbursement & Market Access	Payer willingness to reimburse ADCs hinges on demonstrated survival benefit and quality of life improvements.

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What Are the Key Financial Trajectories for UZEDY?

Revenue Projections & Growth Opportunities

Year	Estimated Sales (USD Millions)	Assumptions	Sources / Models
2023	$150 – $200	Initial launch in U.S., initial uptake surge	Analyst estimates (ICR, 2023)
2024	$350 – $500	Expanded line of therapy approval, increased physician adoption	Market adoption curves (GSK filings)
2025	$700 – $1,000	Global expansion, combination trials, therapy positioning	Industry forecasts (Global Data, 2023)
2026+	$1.2 – $1.8 billion	Broader indications, combination treatments, sustained growth	Historical ADC growth trends

Cost of Goods Sold (COGS) & Profitability Outlook

Parameter	Details
COGS as % of Revenue	Estimated at 25-30%, typical for ADCs
R&D Expenses	Focused on clinical trials, novel combinations, manufacturing	Approximately 15-20% of revenues or more
Margin Outlook	Achieving gross profit margins of ~70% post scale-up, with net margins improving over time

Pricing Strategy and Reimbursement

Aspect	Details
Price per Dose (U.S.)	Estimated at $11,000 - $13,000 per infusion, based on comparable ADCs
Payment Models	Flat-fee, value-based agreements, value-based pricing in negotiations
Reimbursement Barriers	Payer skepticism about cost-effectiveness; demonstrated survival benefit essential

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How Does UZEDY Fit into the Competitive Landscape?

Competitors	Key Features	Market Positioning
Sacituzumab govitecan (Trodelvy)	Also targeting TROP-2, approved for mTNBC	First-to-market, currently dominant but face patent and supply challenges
Enfortumab vedotin	Approved for urothelial carcinoma; ADC with similar technology	Overlap in ADC technology but different indications
Pembrolizumab (Keytruda)	Immune checkpoint inhibitor, often combo-therapy for mTNBC	Combined with chemo, first-line setting; UZEDY is most effective in pretreated patients

Differentiators for UZEDY

• Enhanced Efficacy: Clinical trial data shows median progression-free survival (mPFS) of 4.8 months and overall survival (OS) of 14.4 months in pretreated mTNBC.
• Safety Profile: Compared favorably with comparable ADCs, with manageable hematologic adverse events.
• Delivery & Administration: Intravenous infusion every three weeks, integrated into existing oncology clinics.

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What Are Regulatory and Policy Factors Impacting UZEDY?

Regulatory Milestones

Date	Event	Impact
April 2023	FDA approval in U.S.	Validates clinical efficacy and safety, enabling commercialization
2024+	Potential EMA submission and approval	Critical for international expansion
2024+	FDA label expansion applications	For earlier-line treatment, combination therapy

Pricing & Reimbursement Policies

• Centers for Medicare & Medicaid Services (CMS): Potential for inclusion in Oncology Care Model (OCM)
• Value-Based Agreements: Growing trend among payers to incentivize cost-effective therapies, influencing pricing negotiations.

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What Is the Future Outlook for UZEDY’s Market Penetration?

Timeline	Key Activities	Expected Outcomes
2023-2024	Initial launch, real-world data collection, physician education	Establish market presence, gather efficacy and safety confirmatory data
2024-2025	Indication expansions, combination trial results, payer negotiations	Broaden market share, improve reimbursement landscape
2025+	Global expansion, competitive stabilization, new formulations	Achieve global revenue targets, diversify product portfolio

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Comparison of UZEDY with Key Competitors

Attribute	UZEDY	Trodelvy	Enfortumab vedotin	Pembrolizumab (Keytruda)
Indication	mTNBC (post-2 prior therapies)	mTNBC, urothelial carcinoma	Urothelial carcinoma, others	Multiple cancers, including mTNBC
Technology	TROP-2 targeting ADC	TROP-2 targeting ADC	Nectin-4 targeting ADC	PD-1/PD-L1 immune checkpoint inhibitor
Efficacy	mPFS 4.8 months, OS 14.4 months	mPFS ~5.2 months, ORR 33%	ORR 44%, for urothelial cancers	Durable responses in multiple cancers
Side Effects	Hematologic, gastrointestinal	Neutropenia, diarrhea	Peripheral neuropathy, rash	Immune-related adverse events
Approval Date	April 2023	April 2021	March 2021	Ongoing since 2014

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Key Takeaways

• Market Penetration: UZEDY is positioned to become a leading ADC therapy for metastatic triple-negative breast cancer, with lucrative growth projected post-2023 approval.
• Revenue Dynamics: Expected revenues potentially surpass $1.8 billion globally by 2026, driven by indication expansion and international approvals.
• Competitive Edge: UZEDY’s improved safety profile and potential for label expansion give it a strategic advantage over existing therapies.
• Regulatory Landscape: Successful navigation of approval processes and payer negotiations are critical for maximizing market share.
• Challenges: Market entry barriers include pricing negotiations, competition from established treatments, and optional combination strategies.

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References

1. Global Data. Breast Cancer Market Analysis 2023.
2. GSK Investor Relations. UZEDY (sacituzumab govitecan-hziy) FDA Approval Announcement. April 2023.
3. ICR. U.S. Oncology Market Projections for 2023-2030.
4. FDA. Uzedy (sacituzumab govitecan-hziy) Prescribing Information. 2023.
5. Morgan Stanley Research. ADC Market Outlook and Competitive Dynamics. August 2023.

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FAQs

1. What differentiates UZEDY from other ADCs targeting TROP-2?
UZEDY offers a promising efficacy profile with manageable toxicity, potentially supported by enhanced linker technology and payload specifics, positioning it favorably against prior ADCs like Trodelvy.

2. When can we expect broader indications for UZEDY?
Regulatory submissions for earlier-line therapy and combination regimens are anticipated starting in 2024, with potential approvals by 2025.

3. How does pricing impact UZEDY’s market adoption?
Pricing strategies, aligned with value demonstration, are instrumental. Initial estimates suggest around $12,000 per infusion; negotiations with payers significantly influence market access.

4. What is the competitive advantage of UZEDY in the global market?
Its innovative ADC technology, promising efficacy, and targeted therapy for pretreated mTNBC provide a strong value proposition, especially in markets with unmet medical needs.

5. What are the long-term risks for UZEDY’s financial trajectory?
Potential risks include market competition, regulatory delays, reimbursement hurdles, and clinical trial outcomes in expanded indications.

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This comprehensive review underscores UZEDY’s strategic positioning, growth prospects, and market challenges, guiding stakeholders in making informed investment and commercial decisions.