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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-one patent family members in twenty-three 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:	51
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	48
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		RX	Yes	Yes	11,931,350			Y
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-003	Oct 30, 2020		RX	Yes	Yes
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-002	Oct 30, 2020		RX	Yes	Yes	11,931,350			Y
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-001	Oct 30, 2020		RX	Yes	Yes	9,309,234		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

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
Cyprus	1119057
South Korea	20180100453	오피오이드 수용체 리간드와 그 용도 및 제조방법 (Opioid Receptor Ligands and Methods of Using and Making Same)
Hungary	E054055
Spain	2632009

OLINVYK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OLINVYK

Introduction

OLINVYK, developed by Trevena, Inc., is a novel G protein-biased (selective) mu-opioid receptor (MOR) ligand approved by the FDA in August 2020 for managing acute pain severe enough to require an intravenous opioid analgesic. Here, we delve into the market dynamics and financial trajectory of OLINVYK.

Market Approval and Launch

OLINVYK was approved by the FDA in August 2020 and commercially launched in February 2021. This approval marked a significant milestone in the treatment of acute pain, especially for patients where alternative treatments are inadequate[4].

Mechanism of Action and Clinical Significance

OLINVYK operates through a novel mechanism of action at the MOR, enabling more selective targeting of newly discovered pathways. This mechanism has the potential for fewer side effects compared to traditional opioids, making it a promising option for acute pain management[3].

Market Forecast and Growth

The global opioid market, which includes OLINVYK, is anticipated to grow at a compound annual growth rate (CAGR) of 1.4% from 2023 to 2030. The market size was valued at USD 22.8 billion in 2022 and is expected to reach USD 25.3 billion by 2030. The growth is driven by the increasing approval and launch of new opioid medicines, including OLINVYK[1].

Segment Performance

OLINVYK falls under the extended-release (ER)/long-acting opioids segment, which accounted for the largest revenue share of 54.2% in 2022 and is expected to grow at the fastest CAGR of 1.7% during the forecast period. The oral segment, which includes opioid tablets like celecoxib and tramadol hydrochloride, is also expected to grow significantly, but OLINVYK's primary route of administration is intravenous[1].

Distribution Channels

The retail pharmacy segment, which accounted for the largest revenue share of 57.0% in 2022, is expected to grow at the fastest CAGR of 1.7%. This growth is attributed to the easy availability of medicines at retail pharmacies and the high opioid dispensing rate. However, OLINVYK is primarily distributed through hospital pharmacies due to its intravenous administration[1].

Financial Performance

Trevena, Inc. has faced significant financial challenges despite the differentiated profile of OLINVYK. The company has reported substantial operating expenses and net losses. For instance, in 2022, Trevena incurred total operating expenses of $55.957 million, leading to a net loss of $53.670 million[2].

Revenue and Expenses

The revenue from OLINVYK has been modest, with the company relying heavily on licensing agreements and other product candidates. The cost of goods sold for OLINVYK increased significantly from $954,000 in 2021 to $3.018 million in 2022, reflecting the commercial launch and initial sales of the product[2].

Cash Flow and Funding

Trevena, Inc. anticipates continuing to incur significant expenses and operating losses as it commercializes OLINVYK and advances other product candidates. The company needs substantial additional funding to support its operations, which it seeks through equity sales, debt financings, or other sources. However, there is no assurance that such funding will be available on favorable terms[2].

Recent Developments and Strategic Adjustments

Despite OLINVYK's potential, Trevena has faced challenges in the hospital environment, leading to a reduction in commercial support for the drug. The company is reviewing strategic alternatives for OLINVYK, including a potential sale, license, or divestiture. This decision aims to preserve capital and focus resources on other promising candidates like TRV045[5].

Real-World Outcomes and Cost Savings

Recent studies, such as the ARTEMIS real-world outcomes study, have highlighted that OLINVYK can reduce cost per admission and average length of stay in hospitals. These findings are significant for healthcare decision-makers but have not yet translated into substantial sales growth for the drug[4].

Competitive Landscape

The opioid market is highly competitive, with major players like Purdue Pharma L.P., Johnson & Johnson Services, Inc., Hikma Pharmaceuticals PLC, and Pfizer, Inc. OLINVYK faces competition from other emerging therapies for acute pain, which could impact its market share in the future[1].

Regulatory and Developmental Activities

OLINVYK has undergone various clinical trials and has received regulatory approvals. The drug's novel mechanism of action and its approval for acute pain management position it as a unique offering in the market. However, the company's ability to navigate regulatory requirements and post-marketing surveillance will be crucial for its continued availability[3].

Key Takeaways

• Market Growth: The global opioid market, including OLINVYK, is expected to grow at a CAGR of 1.4% from 2023 to 2030.
• Financial Challenges: Trevena, Inc. faces significant financial challenges, including high operating expenses and the need for additional funding.
• Strategic Adjustments: The company has reduced commercial support for OLINVYK and is exploring strategic alternatives.
• Competitive Landscape: OLINVYK competes in a highly competitive opioid market with other emerging therapies.
• Regulatory Compliance: Continued regulatory compliance and post-marketing surveillance are essential for OLINVYK's market presence.

FAQs

What is OLINVYK, and how is it used?

OLINVYK is a novel G protein-biased (selective) mu-opioid receptor (MOR) ligand approved for managing acute pain severe enough to require an intravenous opioid analgesic. It is available in various formulations for patient-controlled analgesia (PCA)[4].

What are the key factors driving the growth of the opioid market, including OLINVYK?

The growth is driven by the increasing approval and launch of new opioid medicines, rising incidence of chronic diseases, and the wide availability of extended-release long-acting opioids[1].

What financial challenges is Trevena, Inc. facing with OLINVYK?

Trevena, Inc. is facing significant operating expenses, net losses, and the need for substantial additional funding to support its operations. Despite this, the company has reduced commercial support for OLINVYK to preserve capital[2][5].

How does OLINVYK compare to other opioids in terms of side effects?

OLINVYK has a novel mechanism of action that enables more selective targeting of newly discovered pathways, potentially leading to fewer side effects compared to traditional opioids[3].

What are the strategic alternatives being considered for OLINVYK?

Trevena, Inc. is reviewing strategic alternatives for OLINVYK, including a potential sale, license, or divestiture, to focus resources on other promising candidates[5].

What impact do real-world outcomes studies have on the market perception of OLINVYK?

Studies like the ARTEMIS real-world outcomes study have shown that OLINVYK can reduce cost per admission and average length of stay in hospitals, which is significant for healthcare decision-makers but has not yet translated into substantial sales growth[4].

Sources

1. Grand View Research: Opioids Market Size, Share & Growth Analysis Report, 2030.
2. Marketscreener: TREVENA INC MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
3. GlobeNewswire: United States OLINVYK Drug Insight and Market Forecasts, 2019-2032.
4. Biospace: Trevena Announces New Topline OLINVYK Data Highlighting Reduced Cost Per Admission From ARTEMIS Real-World Outcomes Study.
5. Trevena, Inc.: Trevena Reports Fourth Quarter 2023 Results and Provides Corporate Update.