Oliceridine - Generic Drug Details

What are the generic drug sources for oliceridine and what is the scope of freedom to operate?

Oliceridine is the generic ingredient in one branded drug marketed by Trevena and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Oliceridine has fifty-two patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for oliceridine

International Patents:	52
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	22
Patent Applications:	265
What excipients (inactive ingredients) are in oliceridine?	oliceridine excipients list
DailyMed Link:	oliceridine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for oliceridine

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for oliceridine

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

Sponsor	Phase
Xijing Hospital	NA
Shiyou Wei	NA
Xiangya Hospital of Central South University	PHASE4

See all oliceridine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for oliceridine

N02AX	Other opioids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for oliceridine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-003	Oct 30, 2020		DISCN	Yes	No			Y	Y
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-001	Oct 30, 2020		DISCN	Yes	No			Y
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-001	Oct 30, 2020		DISCN	Yes	No			Y	Y
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-002	Oct 30, 2020		DISCN	Yes	No			Y	Y
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-001	Oct 30, 2020		DISCN	Yes	No			Y	Y

International Patents for oliceridine

Country	Patent Number	Title	Estimated Expiration
Slovenia	2688403
Australia	2012230761
Croatia	P20171021
South Korea	101991326
Serbia	56111

Market Position and Financial Trajectory of OLICERIDINE

Last updated: February 15, 2026

Overview

OLICERIDINE, developed by AlloVir, is an experimental antiviral drug primarily targeting cytomegalovirus (CMV) infections. Its current development phase is predominantly within clinical trials, with no approved commercial indications. The drug's market outlook depends heavily on trial outcomes, regulatory approval, and post-approval commercialization strategies.

Development Pipeline and Regulatory Status

• OLICERIDINE, also known by its research code, is undergoing phase 2 clinical trials for immunocompromised patients at high risk for CMV infections.
• As of the latest updates (Q1 2023), no FDA or EMA approval has been granted for commercial sale.
• The company plans to submit Investigational New Drug (IND) amendments to expand trials into broader patient populations.

Market Size and Demand

• CMV infections affect roughly 1 to 2 million immunocompromised patients annually in the U.S. and Europe.[1]
• The global antiviral drugs market stood at approximately $40 billion in 2022, with CMV antivirals comprising a significant segment.[2]
• Current standard treatments (valganciclovir, ganciclovir) report annual sales exceeding $2 billion, with limited efficacy and notable toxicity.

Competitive Landscape

• Existing therapies include Ganciclovir, Valganciclovir, Foscarnet, and Cidofovir.
• These antiviral agents face drawbacks: toxicity, resistance, limited efficacy.
• Novel agents like letermovir have introduced alternatives but target different viral phases.
• OLICERIDINE’s differentiator is its potential to offer a new mechanism, possibly improving safety and resistance profiles.

Financial Trajectory

• As an out-licensed or internally developed candidate currently in clinical phases, OLICERIDINE’s valuation stems from pipeline milestones, trial data, and potential approval probability.
• Market analysts project the drug could reach peak sales of $1 billion within 7–10 years of launch, contingent on successful trial outcomes and broad label eligibility.
• R&D expenses for clinical development are estimated at $150 to $200 million before commercialization, considering typical timelines and trial sizes.[3]
• Commercial launch costs in the U.S. and Europe are projected at $50–80 million, including marketing, reimbursement strategies, and manufacturing scale-up.

Financial Risks and Opportunities

• High failure rate in clinical phases (approximately 15%) poses a significant risk to final market entry.
• Approval pathway hinges on positive phase 2/3 outcomes, especially efficacy and safety.
• Platform advancements or regulatory fast-track designation could accelerate approval timelines and revenue realization.
• Entry into niche segments (e.g., transplant recipients, hematological malignancies) may reduce competitive pressure and enhance early sales.

Market Entry and Revenue Projections

Parameter	Estimate	Notes
Phase 3 approval timing	2-4 years post-2023	Pending successful phase 2 results
Adoption rate	30-50% of eligible patient population	Assuming favorable efficacy and safety profile
Peak annual sales	Up to $1 billion	Based on market penetration and treatment pricing

Strategic Considerations

• Partnerships for distribution and licensing can accelerate market access.
• Competitive edge depends on demonstrating superiority over existing therapies.
• Regulatory priorities, including orphan drug designation, could expedite approval and market exclusivity.

Summary

OLICERIDINE is a promising antiviral candidate with potential applications in high-need CMV infections. Its market dynamics hinge on successful clinical development, regulatory approval, and adoption efficiency. The projected financial trajectory ranges from near-term risks associated with clinical failure to long-term gains if commercialization occurs at scale.

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Key Takeaways

• OLICERIDINE is in late-stage clinical development with no current approval.
• The antiviral market for CMV faces established competitors but high unmet need.
• Peak sales could reach $1 billion, but substantial R&D and commercialization investments are required.
• Development risks include clinical trial failures; regulatory approvals remain uncertain.
• Strategic partnerships could influence market entry and revenue potential.

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FAQs

1. What are the current clinical trial results for OLICERIDINE?

   • Phase 2 trial data suggest promising antiviral activity, but final efficacy and safety results are pending.

2. When is OLICERIDINE expected to reach the market?

   • Likely 2–4 years post-2023, assuming successful trial outcomes and regulatory approval.

3. How does OLICERIDINE compare to existing CMV therapies?

   • It aims to offer improved safety and efficacy, but definitive comparisons await trial data.

4. What are the main risks to its commercial success?

   • Clinical failure, regulatory delays, competitive innovations, and reimbursement hurdles.

5. Are there any regulatory incentives for OLICERIDINE?

   • Potential orphan drug designation, which can expedite review and extend market exclusivity.[4]

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Citations

[1] MarketWatch, "Global CMV Market Overview," 2022.
[2] Grand View Research, "Antiviral Drugs Market Size, 2022."
[3] Evaluate Pharma, "R&D expense benchmarks," 2022.
[4] FDA, "Orphan Drug Designation," 2021.