ROPIVACAINE HYDROCHLORIDE - Generic Drug Details

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

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

Ropivacaine hydrochloride has seventy-six patent family members in twenty countries.

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

Summary for ROPIVACAINE HYDROCHLORIDE

International Patents:	76
US Patents:	3
Tradenames:	2
Applicants:	13
NDAs:	16
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	189
Clinical Trials:	865
Patent Applications:	370
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
McMaster University	Phase 4
Ziekenhuis Oost-Limburg	N/A
University of Florida	Phase 2

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
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-007	Sep 24, 1996	AP	RX	Yes	No			Y
Rising	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	090318-004	Sep 23, 2014		DISCN	No	No
Rising	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	204636-001	Mar 16, 2018	AP	RX	No	No
Rising	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	090318-002	Sep 23, 2014		DISCN	No	No
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-007	Sep 24, 1996	AP	RX	Yes	No			Y
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-002	Sep 24, 1996	AP	RX	Yes	No
Amneal	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	216605-003	Mar 7, 2023	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	020533-003	May 1, 1998
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-007	Sep 24, 1996
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-003	May 1, 1998
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998

International Patents for ROPIVACAINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Denmark	1507502
Poland	209530
South Africa	200602538	Connector for medical liquid-containing packages and medical liquid-containing packages
Brazil	PI0408780	conector para embalagens contendo lìquidos medicinais e embalagem para lìquidos medicinais
Germany	50312773
Spain	2343456
China	100408013

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

ROPIVACAINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ropivacaine Hydrochloride

Market Overview

The global Ropivacaine Hydrochloride market is poised for significant growth, driven by several key factors. Here are the main dynamics and financial trajectories shaping this market.

Market Drivers

Growing Demand for Pain Management Solutions

The increasing demand for innovative and patient-centric pain management solutions is a primary driver for the Ropivacaine Hydrochloride market. With a rising prevalence of chronic pain conditions such as postoperative pain, neuropathic pain, and musculoskeletal disorders, the need for effective local anesthetic and analgesic interventions is on the rise[1][4].

Opioid-Sparing Strategies

The growing awareness of the risks associated with opioid-based medications has led to a shift towards opioid-sparing pain management strategies. Ropivacaine, with its favorable safety profile and reduced potential for cardiovascular and central nervous system toxicity, is increasingly preferred by healthcare providers[1][4].

Increasing Surgical Procedures

The surge in the number of surgical procedures globally, including cosmetic surgeries, dental procedures, and plastic surgeries, is another significant driver. Approximately 65% of total surgical procedures require post-operative pain management, which boosts the demand for local anesthesia drugs like ropivacaine hydrochloride[3][4].

Market Segmentation

Application Segments

The global Ropivacaine Hydrochloride market can be segmented into anesthesia, labor pain, and postoperative pain. The anesthesia segment dominates the market due to the effectiveness of ropivacaine as a local anesthetic and its lower side effects compared to other local anesthetics[4].

Distribution Channels

The market is also segmented by distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies hold a major market share due to the high number of surgeries performed in hospitals and the easy access to local anesthetics in these settings[4].

Regional Analysis

North America and Europe

North America and Europe are currently the leading regions in the Ropivacaine Hydrochloride market, driven by the high number of surgeries, cases of acute pain after surgery, and the presence of major pharmaceutical companies[4].

Asia-Pacific and Latin America

The Asia-Pacific region, particularly countries like China, India, and Japan, is expected to experience the fastest growth in the coming years. This is due to the expanding healthcare infrastructure, rising prevalence of chronic pain conditions, and increasing focus on improving patient outcomes. Latin America and the Middle East and Africa regions also present significant growth opportunities due to the growing demand for effective pain management solutions and improving access to healthcare[1][4].

Competitive Landscape

The global Ropivacaine Hydrochloride market is highly competitive and fragmented, with both major pharmaceutical companies and emerging players. Key players include Apin Chemicals Limited, NAVINTA LLC, Xiaogan shenyuan chempharm co. Ltd., Akorn, Inc., Pfizer, Inc., Aurobindo Pharma, Teva Pharmaceutical Industries Ltd., Somerset Therapeutics, LLC, Gland Pharma Limited, and EXCELLA GmbH & Co KG[4].

Financial Trajectory

Market Size and Growth

The global Ropivacaine Hydrochloride market is expected to witness exponential growth at a significant CAGR during the forecast period. The global local anesthesia drugs market, which includes ropivacaine hydrochloride, is anticipated to reach USD 5.14 billion by 2030, growing at a CAGR of 3.6% from 2024 to 2030[1][3].

Revenue Drivers

The revenue growth is driven by the increasing demand for effective and well-tolerated local anesthetic and pain management solutions. The introduction of new product formulations, expansion of regulatory approvals, and the integration of advanced drug delivery technologies are also contributing to the market's financial growth[1].

Challenges and Restraints

Regulatory Challenges

Regulatory challenges, potential product quality issues, and supply chain disruptions are among the primary restraints for the market. Additionally, competition from alternative local anesthetic and pain management therapies poses a challenge to the growth of the Ropivacaine Hydrochloride market[1].

Side Effects and Over-Dosage

Side effects of ropivacaine hydrochloride and the potential for over-dosage mortality rates are also factors that could restrain market growth. However, ongoing research and development aimed at enhancing the safety and efficacy of ropivacaine hydrochloride preparations are expected to mitigate these risks[4].

Opportunities for Growth

Emerging Markets

Emerging markets in Asia-Pacific and Latin America present significant growth opportunities due to the expanding healthcare infrastructure and the rising prevalence of chronic pain conditions in these regions[1].

Innovative Product Developments

The development of innovative ropivacaine hydrochloride preparations, including those with enhanced performance characteristics, improved stability, or specialized delivery mechanisms, can drive further market growth. The integration of advanced coating technologies, novel excipients, or digital health capabilities can enhance the overall value proposition of these pain management products[1][4].

Key Takeaways

• The Ropivacaine Hydrochloride market is driven by the growing demand for patient-centric pain management solutions and the rising prevalence of chronic pain conditions.
• The market is expected to grow significantly, driven by the increasing number of surgical procedures and the need for opioid-sparing pain management strategies.
• Asia-Pacific and Latin America are key regions for future growth due to their expanding healthcare infrastructure and rising demand for effective pain management solutions.
• Regulatory challenges and competition from alternative therapies are primary restraints, but ongoing R&D efforts are expected to address these issues.
• Innovative product developments and the integration of advanced technologies will continue to drive market growth.

FAQs

What are the primary drivers of the Ropivacaine Hydrochloride market?

The primary drivers include the growing demand for innovative pain management solutions, the rising prevalence of chronic pain conditions, and the increasing focus on opioid-sparing strategies.

Which regions are expected to experience the fastest growth in the Ropivacaine Hydrochloride market?

The Asia-Pacific region, particularly countries like China, India, and Japan, and Latin America are expected to experience the fastest growth due to expanding healthcare infrastructure and rising demand for pain management solutions.

What are the main challenges facing the Ropivacaine Hydrochloride market?

Regulatory challenges, potential product quality and supply chain issues, competition from alternative therapies, and side effects associated with the drug are the main challenges.

How is the competitive landscape of the Ropivacaine Hydrochloride market?

The market is highly competitive and fragmented, with both major pharmaceutical companies and emerging players. Key players include Apin Chemicals Limited, NAVINTA LLC, and Pfizer, Inc., among others.

What are the future growth opportunities for the Ropivacaine Hydrochloride market?

Future growth opportunities include the development of innovative product formulations, the integration of advanced drug delivery technologies, and the expansion into emerging markets in Asia-Pacific and Latin America.

Cited Sources

1. DataHorizon Research: Ropivacaine Hydrochloride Preparation Market Size, Share, Growth...
2. Synapse by PatSnap: Ropivacaine Hydrochloride - Drug Targets, Indications, Patents
3. GlobeNewswire: Local Anesthesia Drugs Market Size, Share & Trends Analysis Report 2024-2030
4. BioSpace: Ropivacaine Hydrochloride Market: The Anesthesia Segment Dominated the Global Market
5. FDA: Naropin® (ropivacaine HCl) Injection - accessdata.fda.gov