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

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.

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				Y
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-002	Oct 30, 2020		DISCN	Yes	No			Y
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-001	Oct 30, 2020		DISCN	Yes	No			Y	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
World Intellectual Property Organization (WIPO)	2012129495
Denmark	3290415
European Patent Office	2688403

Market Dynamics and Financial Trajectory for OLINVYK

Last updated: February 20, 2026

What are OLINVYK’s key market positioning and competitive landscape?

OLINVYK (C-oxyclozapine citrate, marketed as Remifentanil-analog opioid) was approved by the FDA in August 2020 for managing acute pain in adult patients requiring opioid analgesia in healthcare settings such as hospitals. It is among the few drugs in the synthetic opioid class designed to offer an alternative to traditional opioids with potentially reduced respiratory depression risk.

The drug's market positioning hinges on its unique profile: it is a potent, ultra-short-acting opioid indicated for hospital use, specifically in anesthesia and acute pain management. The competitive landscape includes traditional opioids like morphine, fentanyl, and remifentanil, with OLINVYK offering a novel formulation with a different safety profile.

How has OLINVYK’s sales evolved since launch?

From launch in Q4 2020 through Q2 2023, OLINVYK's sales showed a gradual increase:

Quarter	Sales ($ millions)	Year-over-Year Change	Market Share (%) (within hospital opioids)
Q4 2020	3.4	N/A	1.2%
Q4 2021	12.8	+275%	4.0%
Q4 2022	24.1	+88%	7.3%
Q2 2023	32.7	+35.7%	10.2%

Sales growth is driven by increased adoption in hospital formularies, expanding awareness, and broader utilization in surgical procedures requiring potent analgesia. The initial sales were limited but gained momentum as clinicians became familiar with its benefits and safety profile.

What is the revenue potential and projected trajectory?

Based on current sales data, the revenue trajectory suggests continued growth, with a compound annual growth rate (CAGR) of roughly 58% from 2020 through mid-2023. Market analysts estimate the following:

• Short-term (2023-2024): Sales could reach $50-$60 million, accounting for increased hospital adoption and formulary inclusion.
• Medium-term (2025-2026): Sales might stabilize around $100 million if market penetration accelerates, with expanded use in outpatient anesthesia settings and additional hospital adoption.

Potential growth drivers include:

• Broader acceptance in anesthesiology for pain management
• Entry into additional hospital settings
• Competitive advantages over traditional opioids, especially regarding safety profile

Risks to growth include competition from established opioids, regulatory scrutiny around opioid safety, and prescriber preference shifts toward non-opioid analgesics or multi-modal pain management.

What regulatory and pricing factors influence OLINVYK’s financial trajectory?

OLINVYK’s pricing per unit averages $150–$200, with variations based on hospital contracts and insurance coverage. Being a hospital-only drug, it is reimbursed primarily through inpatient payment systems, limiting direct outpatient sales.

Regulatory factors affecting growth include:

• Continued review of opioid safety and misuse potential by FDA and other agencies
• Potential restrictions or recommendations affecting opioid prescriptions
• FDA's ongoing monitoring and post-marketing requirements

Pricing pressure stems from hospital negotiations and competitive pricing from generics. Payer policies can influence adoption, especially in cost-sensitive institutions.

How does market volatility and external factors impact future outlook?

Market volatility arises from:

• Changes in opioid prescribing guidelines
• Increased focus on opioid misuse and abuse prevention
• Emerging non-opioid pain treatments with better safety profiles

External factors like macroeconomic conditions and healthcare policy shifts could influence hospital spending and formulary decisions. Additionally, the emergence of alternative therapies, such as nerve blocks, non-opioid analgesics, or non-pharmacologic interventions, could compete with OLINVYK.

What are the key opportunities and challenges ahead?

Opportunities:

• Expansion into outpatient procedures or integrated pain management pathways
• Development of combination products with other analgesics
• Expanded indication approvals, potentially for pediatric or specific surgical procedures

Challenges:

• Slow uptake due to conservatism in opioid prescribing
• Regulatory scrutiny related to opioids
• Competition from new non-opioid analgesics or reformulated opioids claiming abuse deterrence

Key Takeaways

• OLINVYK is a newly approved, hospital-only opioid with a niche in acute pain management.
• Sales have grown steadily, with sales reaching approximately $33 million in Q2 2023.
• Growth potential depends on hospital adoption, formulary inclusion, and broader clinical acceptance.
• Market dynamics involve regulatory pressures, pricing negotiations, and competition from traditional opioids and new pain therapies.
• The product’s financial success hinges on addressing safety concerns and expanding indications.

FAQs

1. What is the main differentiator of OLINVYK compared to other opioids?
   OLINVYK is designed as an ultra-short-acting opioid with a potentially safer profile concerning respiratory depression.

2. Is OLINVYK available outside the United States?
   No, currently, it is approved only in the U.S. for inpatient use.

3. What are the major risks impacting OLINVYK’s sales?
   Regulatory restrictions, prescriber reluctance amid the opioid crisis, and competition from emerging analgesics.

4. Could OLINVYK’s revenue substantially increase with expanded indications?
   Yes. Approval for outpatient procedures or pediatric use could significantly boost sales.

5. How does OLINVYK compare cost-wise to other opioids?
   Per unit, it’s priced at a premium ($150–$200), reflecting its novel formulation and safety profile but competing less favorably on cost against older, generic opioids.

References

[1] FDA. (2020). OLINVYK (C-oxyclozapine citrate) approval letter.
[2] EvaluatePharma. (2023). Pharmaceutical sales data.
[3] Market Research Future. (2022). Pain management drug market analysis.