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 is one patent protecting this drug and three Paragraph IV challenges.

This drug has twenty-three patent family members in eighteen 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:	23
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	160
Patent Applications:	199
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 one 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	020533-007	Sep 24, 1996	AP	RX	Yes	No	7,857,802		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	020533-005	Sep 24, 1996	5,670,524
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	4,695,576
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	8,118,802
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-006	Sep 24, 1996	8,162,915

International Patents for NAROPIN

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

Country	Patent Number	Title	Estimated Expiration
Argentina	242561	PROCEDIMIENTO PARA LA PREPARACION DE CLORHIDRATO DE S-(-)-1-PROPIL-2',6'-PIPECOLOXILIDIDA OPTICAMENTE SUSTANCIALMENTE PURO Y PROCEDIMIENTO (PROCEDURE FOR THE PREPARATION OF S-(-)-1-PROPYL-2',6'-PIPECOLOXYLIDIDE HYDROCHLORIDE THAT IS SUBSTANTIALLY PURE, AND THE PROCEDURE INVOLVED.)
Austria	56956
Australia	592392
Australia	6644986

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	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
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

Last updated: July 22, 2026

NAROPIN market dynamics and financial trajectory (Ropivacaine hydrochloride)

NAROPIN (ropivacaine hydrochloride) is a long-cycle local anesthetic with revenue driven by perioperative use in regional anesthesia and pain management, tempered by competitive substitutes (other amide local anesthetics and expanding use of multimodal analgesia). Financial trajectory is shaped by (1) patent and exclusivity timing for drug substance and branded formulations, (2) FDA and payer dynamics for hospital formularies, (3) generic and authorized generic penetration risk, and (4) contract behavior in anesthesia and surgery-driven purchasing channels.

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What is NAROPIN’s market size by use case and where does demand come from?

NAROPIN is used for local/regional anesthesia across perioperative surgery and for postoperative pain strategies. Demand is concentrated in settings where clinicians use block techniques and continuous infusions.

Primary demand drivers

• Perioperative regional anesthesia: adoption of nerve blocks and local infiltration for orthopedic, abdominal, and thoracic surgeries.
• Postoperative analgesia: continued infusions and catheter-based pain control protocols.
• Multimodal pain pathways: substitution pressure from non-opioid analgesics and evolving ERAS protocols affects absolute local anesthetic unit volume, but does not eliminate regional anesthesia demand.

Where revenue typically concentrates

• Hospitals and ambulatory surgery centers with established anesthesia pain pathways.
• Large IDNs with centralized pharmacy contracting that standardize preferred local anesthetic brands (or preferred generics).

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How competitive is NAROPIN versus bupivacaine, lidocaine, and other local anesthetics?

NAROPIN competes in the amide local anesthetic class against brands and generics of:

• Bupivacaine (including long-acting formulations)
• Bupivacaine liposome products (different mechanism and use profile)
• Lidocaine (shorter-acting, broad topical and injection uses)
• Mepivacaine
• Generic ropivacaine products where approved

Competitive dynamics

• Formulary switching: hospitals can replace a branded local anesthetic with a cheaper generic or therapeutic equivalent if procurement allows.
• Clinical preference constraints: dosing, onset, duration, and safety profile influence anesthesiologist selection but often follow institutional protocols.
• Supply and pack-size economics: contract packs, vial sizes, and infusion compatibility matter for pharmacy and anesthesia workflows.

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When does NAROPIN lose exclusivity, and when do generics typically enter?

NAROPIN’s market exclusivity profile is governed by U.S. patent estate status and any listed FDA exclusivities (data exclusivity and marketing exclusivity, if applicable), plus formulation and method-of-use patents for specific presentations.

Market timing mechanics

• If patents covering specific NAROPIN presentations (strengths, pack sizes, and labeling) are expired, generic entry risk rises.
• If only certain presentations remain protected, generics can enter selectively, creating partial erosion.

Financial impact pattern

• Branded anesthetic revenue typically shows:
  • Pre-loss: stable brand volume if contracts are locked.
  • Launch window: rapid share shift after generic availability and substitution decisions.
  • Post-entry: sustained decline unless rebated access keeps brand preferred.

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What does the Orange Book status imply for NAROPIN generic erosion risk?

NAROPIN Orange Book listings determine whether patents are still listed for:

• Drug substance
• Drug product
• Use patents (method-of-use)
• Formulation and manufacturing methods

How Orange Book structure affects commercialization

• Drug product patents: protect a specific strength or dosage form, often delaying substitution for that exact SKU.
• Method-of-use patents: restrict generic labels and can delay full substitution if the competing generic cannot legally market the same claim.
• Device/combination coverage (if any): can complicate switch decisions if protocols require a specific delivery system.

Generic risk hierarchy

1. No remaining listed patents for a presentation and label: highest risk of near-term erosion.
2. Expiration near term: step-down planning by hospitals and payers accelerates pre-switch procurement.
3. Use or formulation patents remain: partial protection, with generics entering only where label carve-outs are legally feasible.

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What patent estate strength issues drive NAROPIN financial outcomes?

Brand longevity in local anesthetics is less about “blockbuster” utilization and more about contract lock, SKU coverage, and patent geography. The NAROPIN financial trajectory depends on how broadly patents covered:

• ropivacaine hydrochloride substance,
• specific drug product presentations,
• and any use claims in regional anesthesia and postoperative analgesia.

Estate-driven outcomes

• Broad, long-lived protection: slower erosion and longer branded pricing power.
• Fragmented estate across SKUs: staggered generic entry and gradual revenue decline rather than a single cliff.
• Settled generic challenges: often results in authorized generics or delayed launches, reducing volatility.

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What NAROPIN patent litigation or Paragraph IV challenges have shaped entry timing?

Paragraph IV certifications and litigations are typically visible through:

• FDA ANDA litigation tracking,
• federal court dockets,
• and settlement filings that often include an agreed launch date.

How litigation affects financial trajectory

• Filed challenge: triggers market anticipation and payer preparations.
• Settlement: often introduces a defined “delayed generic launch” window.
• Unfavorable rulings: can accelerate generic launches and trigger faster revenue erosion.

Outcome pattern in this category

• Local anesthetic brands often face multiple filings across strengths and packaging.
• Even if one strength is protected, others may lose first, producing “rolling” erosion.

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How do NAROPIN payer and contracting dynamics affect realized price and revenue?

Even when unit demand holds, realized price can decline from:

• formulary tier changes,
• PBM contracting strategies (if applicable by channel),
• hospital group purchasing organization (GPO) negotiations,
• and rebating practices tied to volume commitments.

Hospital procurement behavior

• Regional anesthesia supply chains use standardized block kits and catheter systems.
• If a therapeutic alternative enters as a low-cost generic, pharmacy typically pushes conversion for cost containment.

Financial translation

• A stable number of cases can still produce lower revenue through:
  • unit price compression,
  • mix shift to cheaper vials,
  • and contract-driven rebates.

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Which FDA pathway and regulatory status factors matter for NAROPIN commercialization and generic substitution?

NAROPIN is an FDA-approved injectable local anesthetic. Generic substitution depends on whether the competing product:

• matches strength and dosage form,
• meets labeling requirements,
• and has an Orange Book challenge outcome that supports approval and marketing.

Regulatory factors that affect financial impact

• Label match vs. carve-outs: if use patents constrain labeling, substitution can be delayed.
• Presentation match: if only certain strengths remain protected, generics can still take share in unprotected SKUs.
• Post-approval changes: supplements and labeling updates can sometimes trigger new patent-relevant labeling restrictions.

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What product presentations (strengths, pack sizes) drive NAROPIN revenue and which are most exposed?

Revenue exposure in local anesthetics is typically SKU-specific. Exposed presentations are those where:

• drug product patents have expired,
• or fewer remaining listed patents cover the exact labeled strength and concentration.

Key SKU exposure logic

• Higher-demand strengths tend to face faster share capture once generics are approved.
• Less common strengths may retain brand preference longer if hospital formularies do not standardize those SKUs.

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How does NAROPIN’s financial trajectory compare with other regional anesthesia brands?

Local anesthetic brand trajectories tend to converge under the same forces:

• patent expiry and generic entry,
• hospital cost-containment,
• and replacement by therapeutic equivalents.

General comparison drivers

• Branded vs. generic mix: measured by contract status and substitution rules.
• Institutional entrenchment: clinicians can be protocol-bound, limiting switching early.
• Competitive intensity: crowded amide anesthetic class increases switching probability.

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What generic entry risks exist for NAROPIN by geography and how fast can erosion occur?

Erosion speed depends on:

• the presence of multiple approved generics,
• distribution coverage,
• hospital formulary policies,
• and whether competitors use authorized generic models.

Geographic risk model

• U.S.: Orange Book and ANDA landscape typically drive the fastest erosion.
• EU and other markets: protection depends on local patent enforcement and local regulatory filings, which can slow or shift entry.

Time-to-erosion pattern

• After approval and contracting, switching can occur quickly within hospital formulary cycles, especially when pharmacy lead time aligns with budget cycles.

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How many patents cover NAROPIN, and what categories most affect business exposure?

Patent count and categories drive exposure more than headline expiration dates. Categories that matter most for business risk:

• Drug substance patents: higher-level protection; if expired, generics can still be constrained by product/use patents.
• Drug product patents: protect specific strengths/concentrations and can slow substitution.
• Use patents: can restrict label and delay switching if the generic cannot fully replicate claims.

A complete coverage map requires matching each Orange Book listed patent to each NAROPIN presentation and determining status (expires, litigation, or stayed entries).

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What NAROPIN commercialization levers (price, contracts, supply) sustain revenue post-entry?

Post-entry durability depends on:

• continued preferred access through contracting and rebates,
• patient safety and clinical familiarity in anesthesia teams,
• supply reliability and distribution coverage,
• and availability of pack sizes aligned with regional anesthesia kits.

Typical brand countermeasures

• negotiate hospital group contracts that keep brand on formularies longer,
• offer competitive net pricing tied to volume,
• maintain clinician-facing training aligned to protocol adoption.

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Key Takeaways

• NAROPIN demand is anchored in perioperative regional anesthesia and postoperative pain management, but unit growth can be offset by multimodal analgesia protocols.
• Financial trajectory is primarily driven by formulary access and realized price, not only by case volume.
• Generic erosion risk hinges on Orange Book coverage by presentation and on patent categories (drug product and use patents) that constrain label substitution.
• Patent litigation and settlements determine whether erosion occurs in a single cliff or rolling SKU-by-SKU declines.
• Competitive pressure from other amide local anesthetics and generic ropivacaine products makes contract behavior and SKU mix the dominant determinants of revenue durability.

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FAQs

1. What drives hospital switching from NAROPIN to generic ropivacaine?
   Net contract price, formulary tier placement, SKU match to protocols, and labeling substitutability.

2. Do method-of-use patents for regional anesthesia delay generic NAROPIN substitution?
   Yes when they force labeling carve-outs that prevent clinicians from using the generic for the same labeled indication.

3. How do payers influence NAROPIN net price during generic entry windows?
   Through PBM and hospital procurement contracting that accelerates substitution when a lower-cost equivalent appears.

4. Which NAROPIN strengths are most likely to lose share first?
   Higher-volume strengths with the weakest remaining patent coverage and the easiest label match for generics.

5. How do settlement agreements typically affect NAROPIN financial outcomes?
   They often define launch timing and can include delayed entry or agreed launch dates, reducing near-term revenue volatility.

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA ANDA approvals and labeling information for ropivacaine hydrochloride injectable products. U.S. Food and Drug Administration.