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 two patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-one patent family members in twenty countries.

The generic ingredient in NAROPIN is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Nineteen 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:	51
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	160
Patent Applications:	4,970
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
Foisor Orthopedics Clinical Hospital	NA
Hartford Hospital	Phase 4
The University of Texas Health Science Center at San Antonio	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 two 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

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	020533-004	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

International Patents for NAROPIN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1605891
Hong Kong	5493	(S)-(-)-1-PROPYL-2',6'-PIPECOLOXYLIDIDE HYDROCHLORIDE MONOHYDRATE,PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL PREPARATION CONTAINING IT
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 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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NAROPIN

Last updated: July 27, 2025

Introduction

NAROPIN, with the generic name procaine, is a long-established local anesthetic primarily used in dental and surgical procedures. Despite its age and the advent of newer anesthetics, NAROPIN retains a niche presence within the global pharmaceutical landscape. Understanding its market dynamics and financial trajectory necessitates a comprehensive analysis of its therapeutic profile, patent status, competitive environment, regulatory landscape, and emerging market opportunities.

Therapeutic and Market Position

Procaine was first synthesized in the 1900s and became widely adopted as a local anesthetic. Its mechanism involves blocking nerve conduction by inhibiting sodium channels, providing rapid anesthesia with limited systemic toxicity. While newer agents like lidocaine and bupivacaine have supplanted NAROPIN for many indications due to extended duration and better safety profiles, NAROPIN maintains specific utility in certain markets owing to cost considerations, familiarity, and regulatory approvals.

In current clinical practice, NAROPIN's primary applications are limited to dentistry and minor surgical procedures, especially in regions where resource constraints hinder the widespread adoption of newer agents. Its market share has declined in developed economies but persists in developing countries, sustaining its commercial relevance.

Market Dynamics: Drivers and Barriers

Drivers

1. Cost-Effectiveness: NAROPIN is notably inexpensive compared to newer anesthetics, making it a preferred choice in low- and middle-income countries (LMICs). Governments and public health systems favor affordable options, sustaining demand.

2. Regulatory Approvals: The drug enjoys broad regulatory acceptance, especially in markets with limited regulatory stringency. Existing approvals facilitate continued distribution without significant reformulation costs.

3. Familiarity and Clinical Infrastructure: Established familiarity among practitioners and existing supply chains bolster its continued use, especially where newer anesthetics require updated training or equipment.

4. Residual Demand in Niche Markets: In dental practices and minor procedures, where cost and safety profiles are well-understood, NAROPIN remains relevant.

Barriers

1. Emergence of Safer, Longer-Acting Alternatives: A range of newer local anesthetics with improved safety profiles, longer duration, and reduced allergenic potential have eroded NAROPIN’s market share in developed economies.

2. Regulatory Challenges: Increased regulatory scrutiny and demand for newer formulations may limit or complicate approvals, especially when patent or exclusivity rights expire.

3. Limited Innovation: The generic nature and limited R&D around NAROPIN curtail its potential for significant growth or repositioning within the anesthetic landscape.

4. Figure of Market Saturation: In matured markets, the decline has plateaued, and incremental growth prospects are limited.

Patent and Regulatory Landscape

Procaine's patent protection long expired, classifying it as a generic staple. As a result, market competition is intense, with multiple generic manufacturers producing NAROPIN across regions. The patent expiration has led to price erosion, affecting profit margins but enabling broader access and sales volume.

Regulatory pathways for reformulations or new indications are largely closed due to the drug’s age, with approvals primarily centered around manufacturing quality standards. However, in some markets, attempts to develop combination formulations or new delivery systems could generate incremental revenue.

Global Market Analysis

Emerging Markets

In LMICs, NAROPIN's affordability sustains its significance. The World Health Organization (WHO) reports that many developing nations still rely heavily on older anesthetics due to economic constraints [1]. The growth potential in these regions hinges on improving healthcare infrastructure, education, and procurement policies. Demand remains stable, with forecasts predicting modest growth aligned with healthcare expansion.

Developed Markets

Here, NAROPIN has shrunken significantly, supplanted by modern alternatives. The focus then shifts from growth to maintenance of existing distributions and supply chain optimization. Market consolidation among generic producers caps revenue potential and compresses margins [2].

Distribution and Competitive Landscape

The competitive environment is characterized by numerous small to mid-sized manufacturers offering generic procaine. Market entry barriers are typically low, fostering price competition. Larger pharmaceutical firms may produce NAROPIN in-house or source from generic suppliers, while some regional players dominate local markets.

Financial Trajectory and Revenue Forecasts

Historical Revenue Trends

Past revenues for NAROPIN have declined globally, particularly in high-income markets, driven by substitution effects. However, in regions where procurement remains driven by price and regulatory factors, revenues have stabilized. For instance, in Asia, sales have demonstrated resilience due to widespread use and procurement policies favoring generics [3].

Future Outlook

Given the current landscape, the financial trajectory of NAROPIN is expected to follow:

• Plateau in mature markets: Revenues will stabilize or decline marginally in developed economies, with limited potential for significant growth absent reformulation or new indications.

• Gradual growth in emerging markets: Potential for moderate expansion exists due to increasing healthcare access, improved procurement, and rising procedures requiring local anesthesia.

• Pricing Dynamics: Price erosion will continue owing to intense competition and generic commoditization, compressing profit margins further.

• Impact of Regulatory and Policy Changes: Health policy initiatives favoring cost-effective treatment regimens could sustain or slightly boost demand, but regulatory hurdles for modifications may limit significant revenue uplift.

Strategic Considerations for Stakeholders

To optimize the financial trajectory of NAROPIN, stakeholders should pursue strategies such as:

• Developing region-specific marketing to consolidate presence in LMICs.

• Exploring formulations that reduce administration costs or extend shelf-life.

• Investing in regional supply chain optimization to reduce costs.

• Monitoring regulatory shifts to adapt product offerings accordingly.

Conclusion

NAROPIN’s market dynamics reflect its position as an aging, low-cost generic with enduring relevance in specific niches and economies. Its financial trajectory hinges on regional healthcare policies, economic factors, and the competitive landscape of local anesthetics. While growth potential in mature markets remains limited, emerging opportunities in developing regions, driven by healthcare expansion and economic factors, provide a platform for modest revenue stability and incremental growth.

Key Takeaways

• NAROPIN continues to serve a niche market primarily in LMICs, where cost and regulatory familiarity sustain demand.

• The global decline in revenues in high-income markets positions NAROPIN as a commoditized product with limited growth prospects.

• Competitive pressures and patent expirations have driven price erosion, impacting profit margins.

• Strategic focus on regional expansion, cost reduction, and formulation innovation can support ongoing revenue streams.

• Monitoring evolving healthcare policies and procurement trends remains vital for stakeholders seeking to optimize the financial trajectory.

FAQs

1. What are the main therapeutic uses of NAROPIN today?
NAROPIN is primarily used as a local anesthetic in dental procedures, minor surgeries, and specific diagnostic applications, especially in regions where cost constraints favor its use.

2. How does the patent status of procaine influence its market?
Expired patents have led to widespread generic manufacturing, increasing market competition and reducing prices but also limiting the potential for exclusive revenues.

3. What factors limit NAROPIN’s growth in developed economies?
Availability of newer, longer-lasting anesthetics with improved safety profiles, along with regulatory and clinical practice shifts, constrain NAROPIN's growth in mature markets.

4. What opportunities exist for NAROPIN in emerging markets?
Cost-effective supply, expanding healthcare infrastructure, and government procurement policies favoring generics enable moderate growth opportunities.

5. Can reformulating NAROPIN boost its market relevance?
While possible, significant reformulation investments are unlikely given the existing market saturation and preference for newer agents; incremental innovations with cost advantages are more feasible.

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Sources
[1] WHO Model List of Essential Medicines, 21st Edition.
[2] Market Research Future. "Global Local Anesthetics Market," 2022.
[3] IQVIA. "Global Trends in Generic Drug Sales," 2023.