Bupivacaine - Generic Drug Details

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

Bupivacaine is the generic ingredient in seventeen branded drugs marketed by Hengrui Pharma, Pacira Pharms Inc, Innocoll, Innocoll Pharms, Aspiro, Civica, Eugia Pharma, Hikma Pharms, Hospira, Meitheal, Somerset, Steriscience Speclts, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, Amphastar Pharms Inc, and Heron Theraps Inc, and is included in fifty-one NDAs. There are thirty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine has sixty-nine patent family members in thirty countries.

There are twelve drug master file entries for bupivacaine. Two suppliers are listed for this compound.

Summary for bupivacaine

International Patents:	69
US Patents:	37
Tradenames:	17
Applicants:	20
NDAs:	51
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	1,674
Patent Applications:	6,961
Drug Prices:	Drug price trends for bupivacaine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bupivacaine
What excipients (inactive ingredients) are in bupivacaine?	bupivacaine excipients list
DailyMed Link:	bupivacaine at DailyMed

See drug prices for bupivacaine

Recent Clinical Trials for bupivacaine

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

Sponsor	Phase
Yongtao Sun	Phase 4
Montefiore Medical Center	N/A
University Hospital "Sestre Milosrdnice"	N/A

See all bupivacaine clinical trials

Pharmacology for bupivacaine

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for bupivacaine

Anesthetics, Local

Anatomical Therapeutic Chemical (ATC) Classes for bupivacaine

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

Paragraph IV (Patent) Challenges for BUPIVACAINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXPAREL	Injectable Suspension	bupivacaine	133 mg/10 mL	022496	1	2021-12-28
EXPAREL	Injectable Suspension	bupivacaine	266 mg/20 mL	022496	1	2021-08-20

US Patents and Regulatory Information for bupivacaine

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			Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No			Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-001	May 12, 2021		DISCN	Yes	No			Y
Hospira	MARCAINE	bupivacaine hydrochloride	INJECTABLE;SPINAL	018692-001	May 4, 1984	AP	RX	Yes	Yes
Hospira	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	016964-009	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Steriscience Speclts	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091503-002	Oct 18, 2011	AP	RX	No	No

Expired US Patents for bupivacaine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011

EU/EMA Drug Approvals for bupivacaine

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pacira Ireland Limited	Exparel liposomal	bupivacaine	EMEA/H/C/004586 Exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain.in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.	Authorised	no	no	no	2020-11-16

International Patents for bupivacaine

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201001885	СИСТЕМА КОНТРОЛИРУЕМОЙ ДОСТАВКИ
Hungary	E032040
Japan	5285374
European Patent Office	1809329	COMPOSITION LOCALE ANESTHESIQUE A DELIVRANCE SOUTENUE CONTENANT AIBS (SUSTAINED LOCAL ANESTHETIC COMPOSITION CONTAINING SAIB)
Russian Federation	2007114291	СИСТЕМА КОНТРОЛИРУЕМОЙ ДОСТАВКИ
United Kingdom	202312422

Bupivacaine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bupivacaine

Introduction to Bupivacaine

Bupivacaine is a local anesthetic commonly used for postoperative pain management, surgical procedures, and other medical applications. Its market dynamics are influenced by several key factors, including demographic changes, technological advancements, and regulatory approvals.

Global Market Size and Growth

The global 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, growing at a CAGR of 5.6% during the forecast period (2024–2032)[1].

Key Drivers of Market Growth

Increasing Prevalence of Chronic Illnesses

The growing prevalence of chronic illnesses, particularly among the aging population, is a significant driver of the bupivacaine market. As the population ages, the number of surgical procedures increases, leading to a higher demand for effective postoperative pain management solutions like bupivacaine[1][4].

Technological Advancements and New Approvals

Advancements in anesthetic technologies and new regulatory approvals are crucial for market growth. For instance, PaciraBioSciences Inc.'s supplemental new drug application (sNDA) for the extended use of its Exparel (Bupivacaine Liposome Injectable Suspension) in pediatric patients was accepted by the US FDA in March 2021, which is expected to provide substantial market growth opportunities[1].

Shift Toward Non-Opioid Pain Relief

The healthcare industry is witnessing a significant shift toward non-opioid pain relief methods due to the high rate of opioid addiction. This trend has intensified the demand for alternatives like liposomal bupivacaine, driving R&D investments and expanding its applications beyond surgical pain to chronic and acute pain conditions[4].

Regional Market Analysis

North America

North America holds a significant share of the bupivacaine market, driven by high healthcare spending, a well-established healthcare infrastructure, and a strong focus on non-opioid pain management. The United States is expected to contribute substantially to the market growth due to favorable reimbursement policies, increased demand for better patient care, and technological advancements[1][4].

Europe

Europe follows closely behind North America, with increasing adoption rates driven by a rising focus on patient-centered pain management. The region is expected to see continued growth as healthcare providers become more aware of the benefits of liposomal bupivacaine[4].

Asia-Pacific

The Asia-Pacific region is anticipated to witness the highest growth rate, driven by a large patient base, rising awareness about non-opioid pain solutions, and improving healthcare access. Emerging markets in this region present substantial growth opportunities for companies and investors[1][4].

Financial Performance of Key Players

Heron Therapeutics

Heron Therapeutics, a key player in the market, reported significant growth in its acute care and oncology care franchises. For instance, the net product sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution increased to $5.6 million in Q4 2023, up from $3.9 million in the same period in 2022. The company also received FDA approval for the expanded indication of ZYNRELEF, which is expected to cover approximately 13 million procedures annually[2].

PaciraBioSciences Inc.

PaciraBioSciences Inc., known for its drug Exparel, is another major player. The company's focus on innovative medications and the acceptance of its sNDA for Exparel in pediatric patients are expected to drive market growth[1].

Challenges and Limitations

Side Effects and Safety Concerns

Bupivacaine injections have potential side effects, including cardiac and CNS function impacts, which can be fatal if not administered cautiously. These adverse effects can stifle market expansion and highlight the need for regular examination and attention during administration[1].

High Costs and Limited Accessibility

High costs and limited accessibility, particularly in low-income regions, are significant challenges that may impact the overall growth of the bupivacaine market. Addressing these issues will be crucial to achieving widespread adoption and maximizing the market’s potential[4].

Cost-Effectiveness and Patient Outcomes

Liposomal bupivacaine has been found to be a cost-effective intervention, particularly in postoperative management, due to the higher likelihood of discharge to home. This cost-effectiveness can contribute to its increased adoption in hospitals and surgical centers[5].

Future Outlook and Investment Opportunities

The future of the bupivacaine market appears promising, driven by the increasing demand for non-opioid pain relief options, rising surgical rates, and the shift toward patient-centered pain management. The market offers attractive investment opportunities due to its expanding market potential, increasing demand for non-opioid solutions, and ongoing R&D efforts to enhance its efficacy and applications[4].

Emerging Markets

Emerging markets in Asia, Latin America, and the Middle East are expected to play a significant role in the future of the bupivacaine market. Improving healthcare infrastructure and rising awareness of non-opioid pain management options in these regions present substantial growth opportunities for companies and investors[4].

Key Takeaways

• The global bupivacaine injection market is projected to grow significantly, driven by the increasing prevalence of chronic illnesses and the shift toward non-opioid pain relief.
• North America and Europe hold significant market shares, but the Asia-Pacific region is expected to witness the highest growth rate.
• Key players like Heron Therapeutics and PaciraBioSciences Inc. are driving market growth through innovative products and regulatory approvals.
• Despite challenges such as side effects and high costs, the market offers promising investment opportunities due to its expanding applications and cost-effectiveness.

FAQs

What is the projected growth rate of the global bupivacaine injection market?

The global bupivacaine injection market is estimated to grow at a CAGR of 5.6% during the forecast period (2024–2032)[1].

Which regions are expected to drive the growth of the bupivacaine market?

North America and Europe currently hold significant market shares, but the Asia-Pacific region is expected to witness the highest growth rate due to a large patient base and improving healthcare access[1][4].

What are the key drivers of the bupivacaine market?

Key drivers include the increasing prevalence of chronic illnesses, technological advancements, new regulatory approvals, and the shift toward non-opioid pain relief methods[1][4].

What are the potential challenges facing the bupivacaine market?

Challenges include potential side effects, high costs, and limited accessibility in certain markets[1][4].

Is bupivacaine a cost-effective option for postoperative pain management?

Yes, liposomal bupivacaine has been found to be a cost-effective intervention due to the higher likelihood of discharge to home during postoperative management[5].

What investment opportunities are available in the bupivacaine market?

The market offers attractive investment opportunities due to its expanding market potential, increasing demand for non-opioid solutions, and ongoing R&D efforts to enhance its efficacy and applications[4].