OLINVYK Drug Patent Profile

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

Olinvyk is a drug marketed by Trevena and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in OLINVYK is oliceridine. One supplier is listed for this compound. Additional details are available on the oliceridine profile page.

DrugPatentWatch^® Generic Entry Outlook for Olinvyk

Olinvyk was eligible for patent challenges on October 30, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 23, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OLINVYK

International Patents:	52
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	115
Drug Prices:	Drug price information for OLINVYK
What excipients (inactive ingredients) are in OLINVYK?	OLINVYK excipients list
DailyMed Link:	OLINVYK at DailyMed

See drug prices for OLINVYK

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

Constraining patent/regulatory exclusivity:

8,835,488

NDA:

210730

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.

US Patents and Regulatory Information for OLINVYK

OLINVYK is protected by five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,835,488.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	210730-001	Oct 30, 2020		DISCN	Yes	No	11,931,350			Y
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-003	Oct 30, 2020		DISCN	Yes	No
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-002	Oct 30, 2020		DISCN	Yes	No	11,931,350			Y

International Patents for OLINVYK

When does loss-of-exclusivity occur for OLINVYK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Montenegro

New Zealand

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OLINVYK around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	243318
New Zealand	713143	Opioid receptor ligands and methods of using and making same
Japan	2016155843

Market Dynamics and Financial Trajectory for OLINVYK: A Comprehensive Analysis

Last updated: July 27, 2025

---

Introduction

OLINVYK (Oliceridine) represents a novel opioid analgesic developed by Indivior PLC, approved by the U.S. Food and Drug Administration (FDA) in August 2020 for managing moderate to severe acute pain. Market entry amid the opioid epidemic, regulatory shifts, and evolving clinical paradigms poses unique challenges and opportunities. This report examines the market dynamics influencing OLINVYK's adoption, analyzes its financial trajectory, and outlines strategic implications for stakeholders.

---

Pharmacological Profile and Clinical Positioning

OLINVYK is marketed as a central-acting analgesic targeting G-protein pathway activation with reduced β-arrestin recruitment, theoretically diminishing typical opioid-related adverse effects such as respiratory depression and constipation. Its novel mechanism positions it as a potential alternative to traditional opioids like morphine, oxycodone, and fentanyl. The drug’s packaging claims improved safety profiles make it attractive in settings emphasizing opioid stewardship.

Clinical data underpinning OLINVYK's efficacy stem from phase III trials demonstrating superior safety margins over conventional opioids with comparable analgesic efficacy. Its intravenous formulation suits postoperative pain management, especially in hospital environments aiming to reduce opioid-related harm.

---

Market Dynamics Influencing OLINVYK’s Adoption

Regulatory Environment

The opioid epidemic has prompted strict regulatory scrutiny, including prescribing guidelines and enhanced monitoring. Agencies advocate for alternative analgesics with better safety profiles, positioning drugs like OLINVYK favorably within evolving formularies. However, regulatory hurdles for novel opioids remain substantial, demanding extensive post-marketing safety data.

Competitive Landscape

OLINVYK enters a segment crowded with opioids (morphine, hydromorphone), NSAIDs, local anesthetics, and emerging non-opioid analgesics (e.g., gabapentinoids, NMDA antagonists). Its differentiation hinges on safety advantages, though uptake depends on comparative clinical outcomes, cost considerations, and prescriber acceptance.

Pricing and Reimbursement

Pricing strategies significantly impact market penetration. As a new-to-market drug, OLINVYK’s cost-effectiveness data influence payer reimbursement decisions. While initial pricing may be premium, insurers seek evidence of reduced complications and shorter hospital stays which could justify higher costs.

Physician Perception and Education

Physician familiarity, confidence in safety claims, and education influence prescriber behavior. Training programs emphasizing OLINVYK’s benefits over traditional opioids can accelerate adoption, especially in hospital settings with stringent opioid policies.

Healthcare System Trends

Hospital pain management protocols increasingly favor multimodal analgesia. OLINVYK’s role within such strategies is pivotal. Its potential to reduce opioid-related adverse events aligns with hospital objectives to enhance patient safety and comply with regulatory standards.

---

Financial Trajectory Projections

Initial Market Penetration

Given the initial FDA approval, OLINVYK’s early sales are expected to be modest, focusing on large academic centers and tertiary hospitals with established pain management protocols. Early adoption hinges on successful educational campaigns, formulary inclusion, and positive clinical outcomes.

Growth Drivers

• Hospital Adoption: As evidence accumulates, hospitals may incorporate OLINVYK into postoperative pain protocols.
• Regulatory Approvals: Expanding indications, such as various inpatient pain settings, can broaden its market.
• Market Expansion: International regulatory approvals could significantly augment revenue, though currently pending.
• Reducing Healthcare Costs: Demonstrated reductions in opioid-related complications may incentivize payers to favor OLINVYK, bolstering market share.

Revenue Projections

Based on comparable niche hospital products, initial annual sales might hover in the low hundreds of millions of USD, with potential to surpass $1 billion within five years if widespread adoption occurs. However, the trajectory depends on competitive pressures, clinician acceptance, and payer policies.

Risks to Revenue Growth

• Market Hesitancy: Skepticism regarding safety claims and clinical efficacy.
• Pricing Pressures: Payer resistance to premium pricing.
• Regulatory Delays: Possible additional safety data requirements or restrictions.
• Emergence of Alternatives: New non-opioid analgesics or biosimilars.

---

Strategic Implications

1. Positioning as a Safer Opioid Alternative: Emphasize clinical data demonstrating reduced adverse effects.
2. Enhancing Educational Outreach: Target key opinion leaders and hospitals to promote evidence-based use.
3. Pricing Strategies: Balance premium positioning with payer access to optimize uptake.
4. Monitoring Market Feedback: Adapt to evolving clinical guidelines and payer policies.
5. Global Expansion: Pursue regulatory pathways in other major markets to diversify revenue streams.

---

Conclusion

OLINVYK’s success hinges on navigating a complex ecosystem shaped by regulatory constraints, clinical acceptance, and competitive forces. Its potential to generate substantial revenues depends on demonstrating real-world safety benefits, securing broad formulary access, and establishing a clinical role within multimodal pain management protocols. While initial prospects are promising, sustained growth requires strategic engagement and evidence generation.

---

Key Takeaways

• Market Entry Challenges: Regulatory scrutiny on opioids necessitates robust safety data and strategic positioning.
• Differentiation Focus: Emphasize OLINVYK’s safety advantages in clinician education to foster prescribing confidence.
• Pricing and Payer Strategies: Competitive pricing and demonstrable cost savings are critical for reimbursement success.
• Clinical Adoption: Hospital protocols favoring reduced opioid adverse events can accelerate uptake.
• Growth Potential: International expansion and broader indications could significantly boost revenue, contingent on regulatory approval and clinical evidence.

---

FAQs

1. How does OLINVYK differ from traditional opioids?
OLINVYK selectively activates G-protein pathways with reduced β-arrestin recruitment, theoretically leading to effective analgesia with fewer adverse effects like respiratory depression and constipation compared to traditional opioids.

2. What are the main challenges in OLINVYK’s market adoption?
Key challenges include clinician skepticism, regulatory hurdles, pricing negotiations, and competition from established opioids and non-opioid analgesics.

3. What is the projected revenue outlook for OLINVYK in the next five years?
Initial annual sales are expected to start in the hundreds of millions USD, with potential to exceed $1 billion if adoption widens through formulary inclusion and expanded indications.

4. How significant is the role of payers in OLINVYK’s market success?
Payer reimbursement policies heavily influence prescriber access; demonstrating cost-effectiveness and safety benefits is essential to secure favorable coverage.

5. Are there international markets for OLINVYK?
Yes, though approval is pending in many regions. International expansion could substantially augment its global revenue, contingent upon regulatory approval and payer acceptance.

---

Sources

1. FDA. FDA approves innovative pain medicine OLINVYK (Oliceridine). August 2020.
2. Indivior PLC. OLINVYK product dossier. 2020.
3. Market research reports on opioid analgesics and hospital pain management trends.
4. Clinical trial registries and published safety and efficacy data for OLINVYK.