~ Buy the ZYNRELEF KIT (bupivacaine; meloxicam) Drug Profile, 2024 PDF Report in the Report Store ~

ZYNRELEF KIT Drug Patent Profile

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

Zynrelef Kit is a drug marketed by Heron Theraps Inc and is included in one NDA. There are sixteen patents protecting this drug.

This drug has eighty-one patent family members in twenty countries.

The generic ingredient in ZYNRELEF KIT is bupivacaine; meloxicam. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupivacaine; meloxicam profile page.

DrugPatentWatch^® Generic Entry Outlook for Zynrelef Kit

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 20, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZYNRELEF KIT

International Patents:	81
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
DailyMed Link:	ZYNRELEF KIT at DailyMed

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

Constraining patent/regulatory exclusivity:

10,213,510

NDA:

211988

Dosage:

SOLUTION, EXTENDED RELEASE;PERIARTICULAR

^*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 ZYNRELEF KIT

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

Sponsor	Phase
Dr. Yannis Raftopoulos	Phase 4
Baptist Health South Florida	Phase 4
Mayo Clinic	Phase 4

See all ZYNRELEF KIT clinical trials

Pharmacology for ZYNRELEF KIT

Drug Class	Amide Local Anesthetic Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Local Anesthesia

US Patents and Regulatory Information for ZYNRELEF KIT

ZYNRELEF KIT is protected by sixteen US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,213,510.

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
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-004	May 12, 2021		RX	Yes	Yes
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No	10,213,510		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-002	May 12, 2021		RX	Yes	Yes	10,980,886		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No	11,083,730		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-004	May 12, 2021		RX	Yes	Yes	9,913,909
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No	10,898,575		Y

EU/EMA Drug Approvals for ZYNRELEF KIT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Heron Therapeutics, B.V.	Zynrelef	bupivacaine, meloxicam	EMEA/H/C/005205 Zynrelef is indicated for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults (see section 5.1).	Withdrawn	no	no	no	2020-09-24

International Patents for ZYNRELEF KIT

When does loss-of-exclusivity occur for ZYNRELEF KIT?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Taiwan

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 ZYNRELEF KIT around the world.

Country	Patent Number	Title	Estimated Expiration
China	114886899
Canada	2906666	COMPOSITIONS D'UN POLYORTHOESTER ET D'UN SOLVANT APROTIQUE (COMPOSITIONS OF A POLYORTHOESTER AND AN APROTIC SOLVENT)
Taiwan	201605445	Long-acting polymeric delivery systems
Japan	2019194267	ポリオルトエステルおよび有機酸添加剤の組成物 (COMPOSITIONS OF POLYORTHOESTER AND ORGANIC ACID EXCIPIENT)
Australia	2020250230	COMPOSITIONS OF A POLYORTHOESTER AND AN APROTIC SOLVENT
European Patent Office	3509601	COMPOSITION PHARMACEUTIQUE COMPRENANT UN SYSTÈME D'ADMINISTRATION, UN ANESTHÉSIQUE LOCAL DE TYPE AMIDE ET UN MÉLOXICAM (A PHARMACEUTICAL COMPOSITION COMPRISING A DELIVERY SYSTEM, AN AMIDE-TYPE LOCAL ANESTHETIC, AND MELOXICAM)

ZYNRELEF KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZYNRELEF KIT

Introduction

ZYNRELEF, a drug developed by Heron Therapeutics, is an extended-release solution combining bupivacaine and meloxicam, designed to address postoperative pain without the use of opioids. Despite its promising potential, the drug's launch has faced several challenges. Here, we delve into the market dynamics and financial trajectory of ZYNRELEF.

Regulatory Journey and Approval

ZYNRELEF's path to approval was not straightforward. The drug encountered two complete response letters from the FDA, which delayed its approval until May 2022. Additionally, the FDA approved ZYNRELEF with a more restrictive label than anticipated, which could impact its market adoption[1].

Early Launch Challenges

The initial launch of ZYNRELEF has been marked by significant challenges. In the fourth quarter of 2022, the drug's sales were just $0.8 million, far below Jefferies' expectations of around $4 million. This disparity has led analysts to express concerns about the drug's launch trajectory, indicating it may take longer than expected to gain clarity on its market performance[1].

Sales Performance

Quarterly and Year-to-Date Sales

As of the third quarter of 2024, ZYNRELEF's net product sales have shown some improvement. For the three and nine months ended September 30, 2024, sales were $6.3 million and $17.1 million, respectively. This represents an increase from the same periods in 2023, where sales were $4.4 million and $12.0 million, respectively[2][4].

Comparative Analysis

Comparing the sales figures, it is evident that ZYNRELEF is gradually gaining traction. For instance, in the second quarter of 2024, ZYNRELEF's net product sales were $5.8 million and $10.8 million for the three and six months ended June 30, 2024, up from $4.2 million and $7.7 million in the same period of 2023[5].

Market Dynamics

Competitive Landscape

The postoperative pain management market is highly competitive, with various opioid and non-opioid alternatives available. ZYNRELEF's unique formulation and FDA approval position it as a significant player, but it must navigate this competitive landscape to achieve substantial market share.

Regulatory Support

A crucial factor in ZYNRELEF's market dynamics is the regulatory support it has received. The CMS Final Rule Non-Opioid Policy for Pain Relief includes ZYNRELEF as a qualifying product for separate payment in both hospital outpatient department and ambulatory surgical center settings. This policy sets a strong precedent and is expected to influence other payors, potentially boosting ZYNRELEF's adoption[4].

Financial Trajectory

Revenue Projections

Heron Therapeutics has narrowed its full-year 2024 guidance for product revenues, expecting a range of $140 million to $146 million. This adjustment reflects the company's optimism about ZYNRELEF's growing revenue, among other products[4].

Adjusted EBITDA

The company reported a positive Adjusted EBITDA of $1.4 million for the year-to-date 2024, indicating a move towards financial stability. The guidance for Adjusted EBITDA has been revised to a range of $(10.0) million to $3.0 million for the full year 2024, suggesting a cautious yet positive outlook[4].

Operating Expenses

Heron Therapeutics has been managing its operating expenses efficiently. The adjusted operating expenses for 2024 are expected to be in the range of $101 million to $105 million, down from the original guidance. This reduction is a result of the company's efforts to balance revenue growth with financial efficiency[4].

Product Enhancements and Partnerships

Vial Access Needle (VAN) Approval

In September 2024, the FDA approved the Vial Access Needle (VAN) for ZYNRELEF, which is expected to enhance the product's usability and appeal in the surgical setting. This approval is seen as a significant step towards increasing the drug's adoption[4].

CrossLink Partnership

Heron Therapeutics has also announced the rollout of its CrossLink partnership, which is expected to further boost ZYNRELEF's market presence. These strategic partnerships and product enhancements are critical for the drug's long-term success[4].

Industry Expert Insights

Industry experts have highlighted the potential of ZYNRELEF in the postoperative pain management market. Despite the initial challenges, the drug's unique formulation and regulatory support position it for significant growth.

"The future looks bright as we continue to grow all product revenue. The CrossLink partnership roll out, FDA approval of the VAN in September, and inclusion in the CMS Final Rule Non-Opioid Policy for Pain Relief, positions ZYNRELEF for significant growth within the surgical setting."[4]

Statistical Highlights

• Q4 2022 Sales: $0.8 million[1]
• Q3 2024 Sales: $6.3 million (three months), $17.1 million (nine months)[2][4]
• Adjusted EBITDA YTD 2024: $1.4 million[4]
• Expected Q4 2024 Net Revenue: $37 million - $43 million[4]
• CMS Policy Impact: ZYNRELEF qualifies for separate payment in hospital outpatient and ambulatory surgical center settings[4]

Key Takeaways

• ZYNRELEF faced initial launch challenges, including lower-than-expected sales and regulatory hurdles.
• The drug has shown gradual sales growth, with $6.3 million and $17.1 million in sales for the three and nine months ended September 30, 2024.
• Regulatory support, such as the CMS Final Rule, is expected to boost adoption.
• Product enhancements like the Vial Access Needle and strategic partnerships are crucial for its market success.
• Heron Therapeutics is managing its finances efficiently, with a positive Adjusted EBITDA and narrowed financial guidance.

FAQs

What is ZYNRELEF, and how does it differ from other pain management drugs?

ZYNRELEF is an extended-release solution combining bupivacaine and meloxicam, designed to manage postoperative pain without using opioids. This differentiation is significant in a market where opioid alternatives are increasingly sought after.

What were the initial challenges faced by ZYNRELEF during its launch?

ZYNRELEF encountered regulatory delays with two complete response letters and a more restrictive FDA label than anticipated. Additionally, its fourth-quarter 2022 sales were significantly below analyst expectations.

How has ZYNRELEF's sales performance been in recent quarters?

As of the third quarter of 2024, ZYNRELEF's sales have shown improvement, with $6.3 million and $17.1 million in sales for the three and nine months ended September 30, 2024, respectively.

What regulatory support has ZYNRELEF received, and how does it impact its market adoption?

ZYNRELEF is included in the CMS Final Rule Non-Opioid Policy for Pain Relief, qualifying it for separate payment in hospital outpatient and ambulatory surgical center settings. This policy is expected to influence other payors and boost ZYNRELEF's adoption.

What product enhancements and partnerships are expected to impact ZYNRELEF's market presence?

The FDA approval of the Vial Access Needle (VAN) and the rollout of the CrossLink partnership are expected to enhance ZYNRELEF's usability and market appeal.

What is Heron Therapeutics' financial outlook for ZYNRELEF and other products?

Heron Therapeutics has narrowed its full-year 2024 guidance, expecting product revenues in the range of $140 million to $146 million. The company also reported a positive Adjusted EBITDA of $1.4 million for the year-to-date 2024.

Sources:

1. FiercePharma: Heron's opioid alternative Zynrelef, slated for blockbuster status, hits rough patch in Q4.
2. Heron Therapeutics: Heron Therapeutics Announces Third Quarter 2024 Financial Results and Narrows Financial Guidance.
3. PR Newswire: Heron Therapeutics Announces Third Quarter 2023 Financial Results and Updates Financial Guidance.
4. Heron Therapeutics: Heron Therapeutics Announces Third Quarter 2024 Financial Results and Narrows Financial Guidance (PDF).
5. Heron Therapeutics: Heron Therapeutics Announces Second Quarter 2024 Financial Results.