BUPIVACAINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for bupivacaine hydrochloride and what is the scope of freedom to operate?

Bupivacaine hydrochloride is the generic ingredient in thirteen branded drugs marketed by 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, and Amphastar Pharms Inc, and is included in forty-seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine hydrochloride has eighty-three patent family members in twenty-four countries.

There are six drug master file entries for bupivacaine hydrochloride. Twenty-two suppliers are listed for this compound.

Summary for BUPIVACAINE HYDROCHLORIDE

International Patents:	83
US Patents:	2
Tradenames:	13
Applicants:	16
NDAs:	47
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	1,674
Patent Applications:	1,141
What excipients (inactive ingredients) are in BUPIVACAINE HYDROCHLORIDE?	BUPIVACAINE HYDROCHLORIDE excipients list
DailyMed Link:	BUPIVACAINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BUPIVACAINE HYDROCHLORIDE

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 HYDROCHLORIDE clinical trials

Pharmacology for BUPIVACAINE HYDROCHLORIDE

Drug Class	Amide Local Anesthetic Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for BUPIVACAINE HYDROCHLORIDE

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for BUPIVACAINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma Pharms	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	204842-003	Feb 11, 2021	AP	RX	No	No
Hospira	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	018053-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Steriscience Speclts	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-003	Oct 18, 2011	AP	RX	No	No

International Patents for BUPIVACAINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	6720279
European Patent Office	3536748	COLLAGÈNE MODIFIÉ (A MODIFIED COLLAGEN)
Mexico	368037	COLÁGENO MODIFICADO. (A MODIFIED COLLAGEN.)

Market Dynamics and Financial Trajectory for Bupivacaine Hydrochloride

Introduction to Bupivacaine Hydrochloride

Bupivacaine hydrochloride is a local anesthetic belonging to the amide class, widely used for numbing specific areas of the body during medical procedures, managing pain during surgeries, childbirth, and postoperative care. Its long-lasting analgesic effects make it a valuable medication in various medical settings.

Global Market Size and Forecast

The global market for bupivacaine hydrochloride is projected to experience significant growth over the next few years. Here are some key financial projections:

• Current Market Size: The global bupivacaine hydrochloride market was valued at approximately USD 251 million in 2023[1].
• Forecasted Market Size: It is expected to reach USD 361.9 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period of 2024-2030[1].
• Alternative Projections: Another report indicates that the bupivacaine HCl market was valued at USD 265.06 million in 2023 and is projected to reach USD 432.83 million by 2032, with a CAGR of 5.6% from 2024-2032[4].

Market Drivers

Several factors are driving the growth of the bupivacaine hydrochloride market:

• Increasing Surgical Procedures: The rise in surgical procedures, including orthopedic surgeries, dental procedures, and obstetrics, is a significant driver. Bupivacaine HCl is commonly used in these procedures to provide effective pain relief[4].
• Growing Geriatric Population: The expanding geriatric population increases the demand for pain management solutions, as older individuals are more likely to undergo surgeries and experience chronic pain conditions[3][4].
• Technological Advancements: Improvements in drug delivery systems and formulations enhance the efficacy and safety profile of bupivacaine HCl, fostering its adoption in surgical settings[4].
• Regional Anesthesia Demand: The increasing demand for regional anesthesia is a major driving force behind the growth of the bupivacaine HCl market[4].

Regional Market Analysis

The global bupivacaine hydrochloride market is segmented geographically, with different regions contributing significantly:

• North America: This region dominates the market due to high healthcare expenditure, advanced healthcare infrastructure, and a growing number of surgeries performed. The United States is expected to drive significant growth at the national level[3][4].
• Europe: Europe follows closely, driven by increasing awareness of pain management and supportive government initiatives[4].
• Asia Pacific: This region is witnessing significant growth attributed to rising healthcare investments, improving healthcare infrastructure, and increasing adoption of advanced pain management techniques. Countries like China and India offer lucrative opportunities due to their large population base and improved healthcare access[4].

Competitive Landscape

The bupivacaine hydrochloride market is competitive, with several key players:

• Major Companies: Pfizer, Fresenius Kabi, Hikma Pharmaceuticals, Baxter, Eugia Pharma, Hunan Zhengqing Pharmaceutical, and Hunan Kelun Pharmaceutical are among the prominent players in the market[1].
• Innovation and R&D: Local pharmaceutical companies, especially in the Asia Pacific region, are focusing on research and development to develop novel formulations and drug delivery systems, including bupivacaine HCl formulations with improved efficacy and safety profiles[4].

Efficacy and Cost-Effectiveness

Recent studies have evaluated the efficacy and cost-effectiveness of bupivacaine hydrochloride, particularly in comparison to liposomal bupivacaine:

• Clinical Efficacy: A randomized clinical trial found that liposomal bupivacaine did not improve postoperative recovery or pain compared to bupivacaine hydrochloride alone among patients undergoing knee replacement surgery. Liposomal bupivacaine was also found not to be cost-effective[2].
• Cost-Effectiveness: The study concluded that liposomal bupivacaine was dominated by the control intervention (bupivacaine hydrochloride alone) in terms of both effectiveness and cost, indicating that bupivacaine hydrochloride remains a more cost-effective option[2].

Side Effects and Safety Considerations

While bupivacaine hydrochloride is effective, it comes with potential side effects that need careful management:

• Cardiac and CNS Effects: Bupivacaine can cause cardiac toxicity, including atrioventricular block, ventricular arrhythmias, and cardiac arrest if administered intravenously in dangerous blood concentrations. Regular examination and caution are necessary to avoid these adverse effects[3].

Market Trends and Future Outlook

The bupivacaine hydrochloride market is expected to continue growing due to several trends:

• Increasing Demand for Pain Management: The growing need for effective pain management solutions, especially in the geriatric population, will drive market growth[4].
• Advancements in Drug Delivery: Technological advancements in drug delivery systems will enhance the efficacy and safety of bupivacaine HCl, further boosting its adoption[4].

Key Takeaways

• The global bupivacaine hydrochloride market is projected to grow significantly, driven by increasing surgical procedures, a growing geriatric population, and advancements in drug delivery systems.
• North America and Europe are key regions, with the Asia Pacific region showing significant growth potential.
• Bupivacaine hydrochloride remains a cost-effective option compared to liposomal bupivacaine.
• Careful management is necessary due to potential side effects.

Frequently Asked Questions (FAQs)

Q: What is the current market size of bupivacaine hydrochloride? A: The global market for bupivacaine hydrochloride was estimated to be worth USD 251 million in 2023[1].

Q: What is the forecasted market size of bupivacaine hydrochloride by 2030? A: The market is expected to reach USD 361.9 million by 2030, growing at a CAGR of 5.4% during the forecast period of 2024-2030[1].

Q: Which regions dominate the bupivacaine hydrochloride market? A: North America dominates the market, followed closely by Europe, with the Asia Pacific region showing significant growth potential[3][4].

Q: What are the major drivers of the bupivacaine hydrochloride market? A: The market is driven by increasing surgical procedures, a growing geriatric population, and technological advancements in drug delivery systems[3][4].

Q: Is liposomal bupivacaine more effective than bupivacaine hydrochloride? A: No, a recent study found that liposomal bupivacaine did not improve postoperative recovery or pain compared to bupivacaine hydrochloride alone and was not cost-effective[2].

Cited Sources:

1. Valuates Reports: Bupivacaine Hydrochloride - Market Size[1]
2. JAMA Network: Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride[2]
3. Straits Research: Bupivacaine Injection Market Size, Share & Trends Analysis Report[3]
4. Introspectivemarketresearch: Bupivacaine HCl Market - Global Size, Share & Industry Trends[4]

Last updated: 2024-12-18