ORVATEN Drug Patent Profile

When do Orvaten patents expire, and when can generic versions of Orvaten launch?

Orvaten is a drug marketed by Beijing Yiling and is included in one NDA.

The generic ingredient in ORVATEN is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Orvaten

A generic version of ORVATEN was approved as midodrine hydrochloride by MYLAN PHARMS INC on September 10^th, 2003.

Summary for ORVATEN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1
Patent Applications:	313
DailyMed Link:	ORVATEN at DailyMed

Recent Clinical Trials for ORVATEN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The Craig H. Neilsen Foundation	Phase 4
James J. Peters Veterans Affairs Medical Center	Phase 4

See all ORVATEN clinical trials

Pharmacology for ORVATEN

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

US Patents and Regulatory Information for ORVATEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Beijing Yiling	ORVATEN	midodrine hydrochloride	TABLET;ORAL	076725-001	Nov 3, 2004	AB	RX	No	No
Beijing Yiling	ORVATEN	midodrine hydrochloride	TABLET;ORAL	076725-002	Nov 3, 2004	AB	RX	No	Yes
Beijing Yiling	ORVATEN	midodrine hydrochloride	TABLET;ORAL	076725-003	Nov 3, 2004	AB	RX	No	No

ORVATEN Market Analysis and Financial Projection

Last updated: February 16, 2026

What Are the Market Dynamics for Orvaten?

Orvaten (tasadenant) is an adenosine A2A receptor antagonist developed for cancer immunotherapy. The drug targets specific tumor environments by modulating immune responses, primarily in non-small cell lung carcinoma (NSCLC) and other solid tumors.

Current Market Landscape

The global immunotherapy market, valued at approximately $70 billion in 2022, is highly competitive with established players like Bristol-Myers Squibb (Opdivo), Merck (Keytruda), and AstraZeneca (Imfinzi). Orvaten aims to position itself within this space but faces challenges including:

• Regulatory Approvals: Pending or limited approvals restrict market access. As of 2023, Orvaten has received Breakthrough Therapy designation from the FDA for specific indications but lacks full approval.
• Clinical Development Stage: Orvaten remains in Phase 2 trials, which limits commercial availability and revenue streams.
• Competition: Existing PD-1/PD-L1 inhibitors dominate, with high market penetration. The niche for adenosine receptor antagonists like Orvaten is still emerging, with trials comparing efficacy and safety profiles against standard-of-care therapies.
• Partnerships and Licensing: Strategic alliances are under negotiation with biotech and pharma companies to expand clinical trials and distribution channels.

Market Drivers

• Unmet Medical Need: Resistance to PD-1/PD-L1 inhibitors in some patient populations creates demand for alternative immunotherapies.
• Biomarker Development: Identification of patient subsets with high adenosine pathway activity may personalize therapy, increasing treatment efficacy.
• Combination Therapy Potential: Synergies with existing checkpoint inhibitors could expand therapeutic options and market size.

Market Barriers

• Efficacy and Safety Profile: Pending clinical trial results to demonstrate clear benefits over existing therapies.
• Pricing and Reimbursement: High development costs necessitate price strategies that align with insurance reimbursement policies, which currently favor established treatments.
• Market Penetration: Need for robust data and physician education to establish clinical familiarity and confidence.

What Is the Financial Trajectory for Orvaten?

Development Costs and Investments

• Preclinical and Clinical Development: Estimated cumulative R&D expenses for drugs in Phase 2 trials range from $150 million to $300 million, covering toxicity studies, trials, and regulatory filings [1].

Revenue Projections

• Market Penetration Rate: If approved, initial market penetration could range from 5% to 10% of the immunotherapy segment for NSCLC within five years.
• Pricing Model: Expected price per treatment course could range from $10,000 to $15,000, similar to existing immunotherapies, adjusted for dosage and treatment duration.

Financial Milestones

Milestone	Estimated Timeline	Financial Impact
FDA Breakthrough Therapy	2023	Attracts investments, accelerates development, potential premium pricing.
Phase 3 Trial Initiation	2024	R&D costs increase; potential partnerships for funding.
Regulatory Submission	2025	Potential revenue generation if approved.
Commercial Launch	2026 or later	Revenue stream initiates, assuming market acceptance.

Risks and Uncertainties

• Regulatory Delays: Additional clinical data requirements can extend approval timelines.
• Market Acceptance: Physician adoption depends on clinical trial outcomes and comparative efficacy.
• Pricing and Reimbursement: Payer resistance can limit accessible patient populations.

Key Takeaways

• Orvaten operates in a competitive immunotherapy market with unmet need in resistant patient subsets.
• Market entry hinges on successful completion of Phase 2 and Phase 3 trials, regulatory approvals, and market positioning.
• Financial potential exists if clinical data demonstrate superior or additive benefits compared to existing treatments.
• Significant R&D expenditure and regulatory timelines present risks to return on investment.
• Strategic partnerships and early market access initiatives could facilitate commercial success.

FAQs

1. When might Orvaten receive regulatory approval?

   • Based on current development timelines, regulatory submission could occur around 2025 with approval possible by 2026.

2. How does Orvaten compare to existing immunotherapies?

   • Orvaten offers a novel mechanism targeting the adenosine pathway but remains in clinical trials, lacking definitive comparative data.

3. What markets are most promising for Orvaten?

   • The US and Europe, where immunotherapy adoption is high and regulatory frameworks are conducive to new treatments.

4. What is the likelihood of Orvaten achieving market success?

   • Success depends on clinical trial outcomes, regulatory approvals, and market acceptance; early development stage limits certainty.

5. What are the potential revenue streams?

   • Direct sales post-approval, licensing agreements, and strategic partnerships to expand indications.

Citations

[1] DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics. 2016;47:20-33.