Ropivacaine hydrochloride - Generic Drug Details

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

Ropivacaine hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Amneal, Caplin, Eugia Pharma, Gland, Hikma, Hospira, Inforlife, Kindos, Mylan Labs Ltd, Navinta Llc, Neocubes Pharma, Rising, and Somerset Theraps Llc, and is included in seventeen NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ropivacaine hydrochloride has fifty-one patent family members in twenty countries.

There are ten drug master file entries for ropivacaine hydrochloride. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ropivacaine hydrochloride

International Patents:	51
US Patents:	2
Tradenames:	2
Applicants:	14
NDAs:	17
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	968
Patent Applications:	448
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ropivacaine hydrochloride
What excipients (inactive ingredients) are in ropivacaine hydrochloride?	ropivacaine hydrochloride excipients list
DailyMed Link:	ropivacaine hydrochloride at DailyMed

Recent Clinical Trials for ropivacaine hydrochloride

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

Sponsor	Phase
Qianfoshan Hospital	NA
Wake Forest University Health Sciences	PHASE4
Wake Forest University Health Sciences	PHASE3

See all ropivacaine hydrochloride clinical trials

Generic filers with tentative approvals for ROPIVACAINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		400MG/200ML (2MG/ML)	SOLUTION;INJECTION
		200MG/100ML (2MG/ML)	SOLUTION;INJECTION
		200MG/20ML (10MG/ML)	SOLUTION;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ropivacaine hydrochloride

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for ropivacaine hydrochloride

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

Paragraph IV (Patent) Challenges for ROPIVACAINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAROPIN	Injection	ropivacaine hydrochloride	2 mg/mL, 200 mL	020533	1	2015-09-03
NAROPIN	Injection	ropivacaine hydrochloride	2 mg/mL, 100 mL	020533	1	2015-01-30
NAROPIN	Injection	ropivacaine hydrochloride	2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials	020533	1	2006-11-13

US Patents and Regulatory Information for ropivacaine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Caplin	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	212808-001	Apr 9, 2020	AP	RX	No	No
Hikma	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	211907-001	Aug 15, 2024	AP	RX	No	No
Rising	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	204636-002	Mar 16, 2018	AP	RX	No	No
Eugia Pharma	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	205612-005	Jul 13, 2016	AP	RX	No	No
Somerset Theraps Llc	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	207636-007	Jun 15, 2018	AP	RX	No	No
Inforlife	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	206166-001	Jun 11, 2018	AP	RX	No	No

Expired US Patents for ropivacaine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-006	Sep 24, 1996
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996

International Patents for ropivacaine hydrochloride

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03099191
Norway	328168
South Korea	100944420
Austria	469630
European Patent Office	2301622	Connecteur pour des emballages contenant des fluides médicaux et emballage pour fluides médicaux (Connector for packaging containing medical fluids and packaging for medical fluids)
Mexico	PA04011784	CONECTOR PARA EMPAQUE QUE CONTIENE FLUIDOS MEDICOS Y EMPAQUE PARA FLUIDOS MEDICOS. (CONNECTOR FOR PACKAGING CONTAINING MEDICAL FLUIDS AND PACKAGING FOR MEDICAL FLUIDS.)

Supplementary Protection Certificates for ropivacaine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0239710	96C0042	Belgium		PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915
0239710	SPC/GB96/051	United Kingdom		PRODUCT NAME: (S)-(-)-1-PROPYL-2',6'-PIPECOLOXYLIDIDE HYDROCHLORIDE MONOHYDRATE (GENERIC NAME: ROPIVACAINE MONOHYDROCHLORIDE MONOHYDRATE); REGISTERED: SE 12319 19950915; SE 12322 19950915; SE 12323 19950915; UK 0017/0375 19960517; UK 0017/0376 19960517; UK 0017/0377 19960517; UK 0017/0378 19960517

Market Dynamics and Financial Trajectory for Ropivacaine Hydrochloride

Last updated: July 27, 2025

Introduction

Ropivacaine Hydrochloride, a long-acting local anesthetic predominantly used in regional anesthesia and postoperative pain management, has established a significant presence within the pharmaceutical landscape. Its favorable safety profile, comparable efficacy to other anesthetics like bupivacaine, and unique pharmacological features position it as a preferred choice among clinicians. This report offers a comprehensive overview of the current market dynamics and financial trajectory for Ropivacaine Hydrochloride, analyzing factors influencing its growth, competitive landscape, regulatory environment, and future prospects.

Pharmaceutical Profile and Clinical Applications

Ropivacaine Hydrochloride belongs to the amide-type local anesthetics, characterized by its ability to block nerve conduction with less cardiotoxicity and neurotoxicity compared to traditional agents such as bupivacaine. It is primarily administered via infiltration, nerve blocks, epidural, and spinal anesthesia, with expanding options in postoperative pain management protocols.

Its usage spans multiple surgical disciplines including orthopedic, obstetric, and general surgeries. The drug's prolonged duration of action—up to several hours—makes it particularly valuable for postoperative analgesia, influencing its adoption in hospital settings globally.

Market Drivers

1. Expanding Surgical Procedures and Anesthesia Demand

Global surgical volume growth directly correlates with increased demand for local anesthetics like Ropivacaine. The rise in minimally invasive surgeries, outpatient procedures, and complex surgical interventions fuel the need for effective, safety-profiled anesthetic agents. According to the World Bank, global surgical procedures are projected to grow annually, underpinning a sustained demand environment.

2. Shift Toward Regional Anesthesia

There's a marked trend favoring regional and local anesthesia techniques over general anesthesia, driven by benefits like reduced recovery time, minimized systemic complications, and enhanced patient comfort. Ropivacaine's attributes align with this shift, boosting its utilization in outpatient settings.

3. Growth in Postoperative Pain Management

Enhanced recovery protocols emphasize effective pain control with minimal opioid use. Ropivacaine's efficacy in postoperative analgesia supports this trend, positioning it as a critical component in multimodal pain management strategies.

4. Regulatory Approvals and Launches in Emerging Markets

Regulatory approvals in several countries expand the drug’s accessibility. Moreover, pharmaceutical companies continually introduce new formulations—such as liposomal versions—that increase product appeal and therapeutic options.

5. Aging Population and Chronic Pain Incidence

An aging global population results in higher prevalence of chronic and surgical pain, expanding the potential user base for Ropivacaine-based anesthetic solutions.

Market Challenges

1. Competition from Alternative Anesthetics

The market faces stiff competition from agents like bupivacaine and lidocaine, which have entrenched positions due to their longer history and established safety profiles. However, Ropivacaine's safety advantages serve as key differentiators.

2. Patent Expirations and Generic Competition

Several formulations of Ropivacaine have lost patent protection, facilitating generic manufacturing, which exerts downward pressure on pricing and profit margins.

3. Regulatory and Safety Concerns

While generally safe, concerns around neurotoxicity at high doses or inappropriate administration remain, necessitating rigorous clinical oversight and potential regulatory scrutiny, especially in emerging markets with less stringent regulations.

4. Cost of Adoption and Training

Integration of Ropivacaine into clinical practice requires clinician familiarity with dosing, administration techniques, and safety protocols, which could slow widespread adoption in certain regions.

Market Segmentation and Competitive Landscape

The Ropivacaine Hydrochloride market can be segmented based on formulation, application, and geography:

• Formulation: Injectable solutions, liposomal formulations, and topical gels.
• Application: Regional anesthesia (nerve blocks, epidurals), postoperative pain management, and infiltration anesthesia.
• Regions: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.

Key Players

Major pharmaceutical firms involved include:

• B. Braun Melsungen AG: A pioneer in Ropivacaine products, with extensive global distribution.
• Hospira (now part of Pfizer): Offers generic formulations contributing to spectrum competition.
• Mitsubishi Tanabe Pharma Corporation: Notable for their Ropivacaine variants in Asian markets.
• Teva Pharmaceuticals: Engages in producing cost-effective generics.

Emerging regional players are also entering through licensing agreements and local manufacturing, further intensifying market competition.

Regulatory and Patent Outlook

The regulatory landscape varies significantly by region. In developed markets like the U.S. and EU, Ropivacaine formulations have long-standing approval statuses, with ongoing post-market surveillance to ensure safety and efficacy.

Patent expiration timelines are crucial for forecasting generic entry. For instance, key patents expired around the late 2010s in several jurisdictions, triggering a wave of generic competitors, resulting in price decreases and increased market penetration.

Upcoming regulatory developments may include approvals for new indications or formulations, further expanding the drug’s market opportunity.

Financial Trajectory and Market Projections

The Ropivacaine Hydrochloride market demonstrates a steady growth trajectory driven by increasing surgical volumes, evolving anesthesia practices, and emerging markets.

Market Size and Growth Rate

According to recent industry reports, the global local anesthetic market was valued at approximately USD 1.7 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 6-8% over the next five years[1].

Ropivacaine-specific segments are estimating a similar growth pattern, with larger regional markets such as North America and Europe expanding more rapidly due to higher surgical volumes and healthcare expenditure.

Revenue Drivers

• Pricing Trends: The initial premium pricing of branded formulations has gradually declined post-patent expiry, while generic versions increase volume but reduce per-unit revenue.
• Market Penetration: Adoption rates in outpatient clinics and developing countries are critical to revenue growth.
• Formulation Innovations: Liposomal and sustained-release formulations command premium pricing, potentially boosting margins.

Forecasted Financials

Predicting exact revenues is challenging due to patent expirations, regional regulatory differences, and market entry barriers. Nonetheless, industry trends suggest:

• An incremental increase in unit sales, particularly driven by generics.
• Surge in adoption due to the global shift toward regional anesthesia techniques.
• Potential for higher margins with innovative formulations and exclusive licensing agreements.

Future Outlook

The future of Ropivacaine Hydrochloride hinges on several factors:

• Technological Innovations: Liposomal formulations and combination drugs could enhance efficacy, safety, and patient compliance, commanding higher prices.
• Market Expansion in Asia-Pacific, Latin America, and Africa: These regions are poised for significant growth owing to expanding healthcare infrastructure and rising surgical volumes.
• Regulatory Approvals for New Indications: Broader approvals could entail increased demand, especially for chronic pain or specific outpatient applications.
• Competitive Pressure: Continued generic entrants and potential biosimilars necessitate strategic differentiation, including formulations and delivery methods.

In conclusion, Ropivacaine Hydrochloride is positioned for steady growth, with opportunities bolstered by global demographic shifts, clinical demand, and technological advancements. Profitability will increasingly depend on strategic patent management, innovation pipelines, and regional market penetration.

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Key Takeaways

• Growing Demand: Increased surgical procedures and a shift toward regional anesthesia support sustained demand for Ropivacaine.
• Market Competition: Patent expirations have introduced a flood of generics, intensifying price competition but offering volume opportunities.
• Regional Expansion: Emerging markets present substantial growth opportunities due to expanding healthcare infrastructure.
• Innovative Formulations: Liposomal and sustained-release variants are poised to command premium pricing and expand therapeutic use.
• Regulatory Dynamics: Evolving regional regulations and approvals impact market access and development timelines.

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FAQs

1. What factors are driving the global demand for Ropivacaine Hydrochloride?
Rising surgical volumes, a shift toward regional anesthesia techniques, the need for effective postoperative pain management, and demographic trends like aging populations are primary drivers.

2. How does patent expiration influence Ropivacaine’s market?
Patent expiration permits generic manufacturers to enter the market, resulting in lower prices, increased competition, and expanded accessibility, though it can reduce profitability for original developers.

3. What are the emerging formulations of Ropivacaine, and what benefits do they offer?
Liposomal and sustained-release formulations extend the duration of analgesia, reduce dosing frequency, and improve patient compliance, allowing for premium pricing and broader application.

4. Which regions are expected to experience the highest growth in Ropivacaine adoption?
Asia-Pacific, Latin America, and Africa present substantial growth prospects due to expanding healthcare infrastructure and surgical activity.

5. What are the main challenges facing Ropivacaine manufacturers?
Pricing pressures from generics, regulatory scrutiny, clinician adoption barriers, and safety concerns pose ongoing challenges.

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References

[1] Markets and Markets. "Local Anesthetics Market by Product, Application, End User – Global Forecast to 2027."