NAROPIN Drug Patent Profile

When do Naropin patents expire, and what generic alternatives are available?

Naropin is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There are three patents protecting this drug and three Paragraph IV challenges.

This drug has seventy-six patent family members in twenty countries.

The generic ingredient in NAROPIN is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naropin

A generic version of NAROPIN was approved as ropivacaine hydrochloride by NAVINTA LLC on July 17^th, 2014.

Summary for NAROPIN

International Patents:	76
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	159
Patent Applications:	6,454
Drug Prices:	Drug price information for NAROPIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAROPIN
What excipients (inactive ingredients) are in NAROPIN?	NAROPIN excipients list
DailyMed Link:	NAROPIN at DailyMed

See drug prices for NAROPIN

Recent Clinical Trials for NAROPIN

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

Sponsor	Phase
Hartford Hospital	Phase 4
The University of Texas Health Science Center at San Antonio	Phase 2
United States Department of Defense	Phase 2

See all NAROPIN clinical trials

Pharmacology for NAROPIN

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Paragraph IV (Patent) Challenges for NAROPIN

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 NAROPIN

NAROPIN is protected by three US patents.

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	020533-010	Jan 4, 2011	AP	RX	Yes	No
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	AP	RX	Yes	No
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-002	Sep 24, 1996	AP	RX	Yes	No
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-006	Sep 24, 1996	AP	RX	Yes	No	7,828,787		Y

Expired US Patents for NAROPIN

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	5,834,489
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996	5,670,524
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-007	Sep 24, 1996	8,118,802
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	5,834,489

International Patents for NAROPIN

See the table below for patents covering NAROPIN around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1507502
Spain	2036179
Canada	2518617	CONNECTEUR POUR EMBALLAGES CONTENANT DES LIQUIDES MEDICAUX ET EMBALLAGE POUR LIQUIDES MEDICAUX (CONNECTOR FOR PACKINGS CONTAINING MEDICAL LIQUIDS, AND CORRESPONDING PACKING FOR MEDICAL LIQUIDS)
World Intellectual Property Organization (WIPO)	9500148

Supplementary Protection Certificates for NAROPIN

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	C960005	Netherlands		PRODUCT NAME: ROPIVACAINI HYDROCHLORIDUM MONOHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 18437, RVG 18440, RVG 18441 19951003; FIRST REGISTRATION: SE 12319, 12322, 12323 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

NAROPIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ropivacaine (NAROPIN)

Introduction to Ropivacaine (NAROPIN)

Ropivacaine, commonly known by its brand name NAROPIN, is a local anesthetic drug widely used in medical procedures for pain management. It is particularly favored for its efficacy in reducing postoperative pain and its relatively lower toxicity compared to other local anesthetics.

Market Segmentation

The global ropivacaine hydrochloride market can be segmented based on several key factors:

Application

• Anesthesia: This segment dominates the market due to the drug's effectiveness as a local anesthetic and its lower side effects compared to other anesthetics[1].
• Labor Pain: Ropivacaine is used to manage pain during labor, contributing to its market growth.
• Postoperative Pain: The drug is extensively used for managing pain after surgeries, which is a significant driver of market demand[1].

Distribution Channel

• Hospital Pharmacies: This segment holds a major market share due to the high number of surgeries performed in hospitals and the easy access to local anesthetics in these settings[1].
• Retail Pharmacies: These pharmacies also play a crucial role, especially for outpatient procedures.
• Online Pharmacies: Although smaller, this segment is growing due to increased online healthcare services[1].

Geographical Regions

• North America: This region dominated the global market in recent years, driven by a high number of surgical procedures and the presence of major pharmaceutical companies[1].
• Europe: Follows closely behind North America in terms of market share.
• Asia Pacific: Expected to grow at a high CAGR due to increasing surgical procedures and rising awareness about surgical safety measures[1].

Market Drivers

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

Increasing Number of Surgical Procedures

The global rise in surgical procedures, including cosmetic, dental, and plastic surgeries, significantly boosts the demand for local anesthetics like ropivacaine[4].

Geriatric Population and Labor Pain Management

The increasing geriatric population and the need for effective labor pain management are key drivers of the market. According to the U.S. Institute of Medicine, 80% of patients who undergo surgery report postoperative pain, with 88% of these patients experiencing moderate, severe, or extreme pain levels[1].

Advancements in Drug Delivery Systems

Improvements in drug delivery systems, such as extended-release formulations, enhance the efficacy and safety of ropivacaine, further driving its adoption[4].

Market Restraints

Despite the growth drivers, there are several restraints affecting the market:

Side Effects and Over-Dosage

Side effects associated with ropivacaine and the increasing rate of over-dosage mortality are significant concerns that could restrain market growth[1].

Regulatory Challenges

Stringent regulatory requirements and the risk of drug failure during clinical development can also impact the market negatively[5].

Financial Trajectory

The financial outlook for ropivacaine hydrochloride is promising:

Revenue Projections

The revenue for ropivacaine ER is expected to reach an annual total of $44 million by 2036 globally, according to GlobalData's Expiry Model[5].

Market Size and Growth

The global local anesthesia drugs market, which includes ropivacaine, is anticipated to reach USD 5.14 billion by 2030, growing at a CAGR of 3.6% from 2024 to 2030[4].

Competitive Landscape

The market is highly competitive and fragmented, with key players including Apin Chemicals Limited, NAVINTA LLC, Pfizer, Inc., Aurobindo Pharma, Teva Pharmaceutical Industries Ltd., and others. This competition drives innovation and pricing strategies that can impact the financial trajectory of the drug[1].

Regional Analysis

• North America: Dominates the market due to a high number of surgical procedures and the presence of major pharmaceutical companies.
• Europe: Follows closely behind North America.
• Asia Pacific: Expected to grow significantly due to increasing surgical procedures and rising healthcare expenditure in countries like India, China, and Brazil[1][4].

Key Players and Their Strategies

Major players in the market are focusing on several strategies to maintain and expand their market share:

Product Development

Companies are investing in research and development to improve the efficacy and safety of ropivacaine formulations. For example, PainReform Ltd's Ropivacaine ER is expected to see significant revenue growth due to its extended-release formulation[5].

Market Expansion

Expanding into emerging markets, particularly in Asia Pacific, is a key strategy. Rising healthcare expenditure and an increasing number of surgeries in these regions offer substantial growth opportunities[1][4].

Illustrative Statistics

• The global local anesthesia drugs market is projected to grow at a CAGR of 3.6% from 2024 to 2030, reaching USD 5.14 billion by 2030[4].
• Approximately 65% of total surgical procedures require post-operative pain management, driving the demand for local anesthetics like ropivacaine[4].

Quotes from Industry Experts

"The introduction of new and effective drugs such as levobupivacaine, articaine, and ropivacaine is also driving the growth of the local anesthesia drugs market across the globe."[4]

Highlight and Citation

"The revenue for Ropivacaine ER is expected to reach an annual total of $44 mn by 2036 globally based off GlobalData’s Expiry Model." - Source: Pharmaceutical Technology[5]

Key Takeaways

• The ropivacaine hydrochloride market is driven by the increasing number of surgical procedures and the need for effective pain management.
• The market is segmented by application, distribution channel, and region, with North America and Europe being the dominant regions.
• Side effects and over-dosage are significant restraints that could impact market growth.
• The financial trajectory is promising, with projected revenue growth and a competitive market landscape.

FAQs

1. What are the primary applications of ropivacaine hydrochloride? Ropivacaine hydrochloride is primarily used in anesthesia, labor pain management, and postoperative pain management.

2. Which region dominates the global ropivacaine hydrochloride market? North America dominates the global ropivacaine hydrochloride market, followed closely by Europe.

3. What are the key drivers of the ropivacaine hydrochloride market? The key drivers include the increasing number of surgical procedures, the growing geriatric population, and advancements in drug delivery systems.

4. What are the major restraints affecting the ropivacaine hydrochloride market? Major restraints include side effects associated with the drug and the increasing rate of over-dosage mortality.

5. Who are some of the key players in the ropivacaine hydrochloride market? Key players include Apin Chemicals Limited, NAVINTA LLC, Pfizer, Inc., Aurobindo Pharma, and Teva Pharmaceutical Industries Ltd.

Cited Sources:

1. Biospace: Ropivacaine Hydrochloride Market: The Anesthesia Segment Dominated the Global Market[1]
2. Pharmaceutical Technology: What is the current valuation of PainReform's Ropivacaine ER[5]
3. GlobeNewswire: Local Anesthesia Drugs Market Size, Share & Trends Analysis Report 2024-2030[4]