BUPIVACAINE; MELOXICAM - Generic Drug Details

What are the generic sources for bupivacaine; meloxicam and what is the scope of patent protection?

Bupivacaine; meloxicam is the generic ingredient in one branded drug marketed by Heron Theraps Inc and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine; meloxicam has eighty-one patent family members in twenty countries.

One supplier is listed for this compound.

Summary for BUPIVACAINE; MELOXICAM

International Patents:	81
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
DailyMed Link:	BUPIVACAINE; MELOXICAM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BUPIVACAINE; MELOXICAM

Constraining patent/regulatory exclusivity:

10,213,510

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 BUPIVACAINE; MELOXICAM

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

Sponsor	Phase
Rothman Institute Orthopaedics	Phase 3
Baptist Health South Florida	Phase 4
TriHealth Inc.	Phase 3

See all BUPIVACAINE; MELOXICAM clinical trials

Pharmacology for BUPIVACAINE; MELOXICAM

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

Anatomical Therapeutic Chemical (ATC) Classes for BUPIVACAINE; MELOXICAM

M01AC	Oxicams
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for BUPIVACAINE; MELOXICAM

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	211988-001	May 12, 2021		DISCN	Yes	No	9,744,163		Y
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	211988-004	May 12, 2021		RX	Yes	Yes	11,253,504
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-004	May 12, 2021		RX	Yes	Yes	10,398,686		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-001	May 12, 2021		DISCN	Yes	No	10,398,686		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-001	May 12, 2021		DISCN	Yes	No	9,801,945		Y

EU/EMA Drug Approvals for BUPIVACAINE; MELOXICAM

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 BUPIVACAINE; MELOXICAM

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)

BUPIVACAINE; MELOXICAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bupivacaine and Meloxicam

Introduction to Bupivacaine and Meloxicam

Bupivacaine and meloxicam are two significant drugs in the pharmaceutical industry, each with distinct uses and market dynamics. Bupivacaine is a local anesthetic, while meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Here, we will delve into the market dynamics and financial trajectories of these drugs.

Bupivacaine Market Dynamics

Global Market Size and Growth

The global bupivacaine injection market is projected to grow significantly over the coming years. By 2032, the market is estimated to reach USD 2,088.37 million, growing at a CAGR of 5.6% from 2024 to 2032[2][4].

Key Drivers

• Increasing Prevalence of Chronic Diseases: The rise in chronic illnesses, particularly among the aging population, is a major driver. This demographic shift increases the number of surgical procedures, which in turn boosts the demand for bupivacaine injections[2][4].
• Advancements in Anesthetic Technologies: Innovations in anesthetic drugs and technologies, such as the approval of new formulations like Exparel (bupivacaine liposome injectable suspension), are driving market growth[2][5].
• Favorable Reimbursement Policies: Government initiatives and favorable reimbursement policies, especially in North America, are contributing to the market's expansion[2][4].

Regional Market Performance

• North America: This region is expected to dominate the global bupivacaine injection market, driven by an expanding patient population and an increase in medical and dental surgical procedures[2][4].
• Asia-Pacific: The APAC region is also expected to show significant growth due to the growing aging population and increasing incidence of chronic diseases[2].

Challenges

• Side Effects: Bupivacaine injections can have serious side effects, such as cardiac and central nervous system issues, which require careful administration and monitoring. These risks can potentially hinder market growth[2][4].

Meloxicam Market Dynamics

Global Market Size and Growth

The meloxicam market is anticipated to reach USD 47 billion by 2036, expanding at a CAGR of around 5% during the forecast period from 2024 to 2036. In 2023, the market size was over USD 7 billion[1].

Key Drivers

• Increasing Prevalence of Arthritis: The growing incidence of osteoarthritis, rheumatoid arthritis, and other chronic pain conditions, especially among the older population, is driving the demand for meloxicam[1].
• Awareness and Consumer Preferences: Increasing awareness about pain relief medications and consumer preferences for effective pain management solutions are boosting the market growth[1].
• Combination Drugs: The segment of combination drugs, which include meloxicam, is expected to grow significantly due to their ability to treat multiple conditions simultaneously[1].

Regional Market Performance

• North America: The meloxicam market in North America is expected to account for the largest revenue share, driven by an increasing number of arthritis and chronic pain patients, along with advanced healthcare infrastructure and R&D activities[1].
• Asia-Pacific: The APAC region is also expected to contribute significantly to the market growth due to the growing aging population and favorable reimbursement policies for generic drugs[1].

Challenges

• Competition from Alternative Treatments: The rise in consumer awareness of alternative treatments like glucosamine and chondroitin sulfate, which help preserve joint motion, could impact the market growth of meloxicam[1].

Financial Trajectory

Bupivacaine

• The bupivacaine injection market was valued at USD 1,120.21 million in 2023 and is projected to reach USD 2,088.37 million by 2032, indicating a steady and significant growth trajectory[2].
• Key players such as Pfizer, Pacira BioSciences, and LGM Pharma are driving innovation and market expansion through new drug approvals and technological advancements[2][5].

Meloxicam

• The meloxicam market, valued at over USD 7 billion in 2023, is expected to reach USD 47 billion by 2036. This substantial growth is driven by the increasing prevalence of arthritis and other chronic pain conditions[1].
• The osteoarthritis segment is estimated to account for the largest revenue share, approximately 40% by the end of 2036, highlighting the significant financial potential of meloxicam in this area[1].

Combined Market Potential: Bupivacaine/Meloxicam ER

Dual-Acting Extended-Release Solution

The combination of bupivacaine and meloxicam in an extended-release (ER) solution, known as Zynrelef (HTX-011), offers a promising market opportunity. This dual-acting solution provides effective postoperative pain management for up to 72 hours with minimal or no opioid use[3].

Market Competition

• Zynrelef is poised to compete with other postoperative pain management drugs like Exparel (bupivacaine liposome injectable suspension) and other local anesthetics. Its approval by the US FDA and potential launch in the US market position it as a significant competitor in the postoperative pain management sector[5].

Financial Impact

• The approval and market entry of Zynrelef are expected to drive substantial market growth, particularly in the postoperative pain management segment. This combination drug leverages the strengths of both bupivacaine and meloxicam, offering a nonopioid solution that mitigates opioid consumption, which is a critical factor in current healthcare strategies[3][5].

Key Takeaways

• Bupivacaine: The bupivacaine injection market is driven by the increasing prevalence of chronic diseases, advancements in anesthetic technologies, and favorable reimbursement policies. It is expected to reach USD 2,088.37 million by 2032.
• Meloxicam: The meloxicam market is driven by the growing incidence of arthritis and chronic pain conditions, as well as increasing consumer awareness. It is anticipated to reach USD 47 billion by 2036.
• Combined Solution: The bupivacaine/meloxicam ER solution (Zynrelef) offers a promising market opportunity in postoperative pain management, leveraging the strengths of both drugs to provide effective, nonopioid pain relief.

FAQs

Q: What is the projected market size for bupivacaine injections by 2032?

A: The global bupivacaine injection market is estimated to reach USD 2,088.37 million by 2032, growing at a CAGR of 5.6% from 2024 to 2032[2].

Q: What are the main drivers of the meloxicam market?

A: The main drivers include the increasing prevalence of osteoarthritis, rheumatoid arthritis, and other chronic pain conditions, as well as increasing consumer awareness about pain relief medications[1].

Q: How does the combination of bupivacaine and meloxicam (Zynrelef) impact the market?

A: Zynrelef offers a dual-acting, extended-release solution for postoperative pain management, reducing or eliminating opioid consumption. It is expected to compete significantly in the postoperative pain management market[3][5].

Q: Which region dominates the bupivacaine injection market?

A: North America is expected to dominate the global bupivacaine injection market due to an expanding patient population and an increase in medical and dental surgical procedures[2][4].

Q: What is the projected market size for meloxicam by 2036?

A: The meloxicam market is anticipated to reach USD 47 billion by 2036, expanding at a CAGR of around 5% during the forecast period from 2024 to 2036[1].

Sources

1. Research Nester: Meloxicam Market Size - Global Forecast Report 2036.
2. Straits Research: Bupivacaine Injection Market Size, Share & Trends Analysis Report.
3. PubMed: Bupivacaine/meloxicam ER: A New Dual-acting Extended Release Solution.
4. GlobeNewswire: Bupivacaine Injection Market to Reach USD 1447 Million by 2030.
5. PR Newswire: Postoperative Pain Market to Rising Steadily at a 7.93% CAGR.