DURANEST Drug Patent Profile

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

Duranest is a drug marketed by Astrazeneca and Dentsply Pharm and is included in two NDAs.

The generic ingredient in DURANEST is etidocaine hydrochloride. Additional details are available on the etidocaine hydrochloride profile page.

Summary for DURANEST

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	31
Patent Applications:	4,763
DailyMed Link:	DURANEST at DailyMed

US Patents and Regulatory Information for DURANEST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	DURANEST	epinephrine; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	DURANEST	epinephrine bitartrate; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	DURANEST	epinephrine bitartrate; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-007	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Dentsply Pharm	DURANEST	epinephrine bitartrate; etidocaine hydrochloride	INJECTABLE;INJECTION	021384-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for DURANEST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-005	Approved Prior to Jan 1, 1982	4,254,114
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-005	Approved Prior to Jan 1, 1982	4,137,309
Astrazeneca	DURANEST	epinephrine bitartrate; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-007	Approved Prior to Jan 1, 1982	3,862,321
Astrazeneca	DURANEST	epinephrine; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-004	Approved Prior to Jan 1, 1982	3,812,147
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-005	Approved Prior to Jan 1, 1982	4,216,211
Astrazeneca	DURANEST	epinephrine bitartrate; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-006	Approved Prior to Jan 1, 1982	3,812,147
Astrazeneca	DURANEST	epinephrine bitartrate; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-007	Approved Prior to Jan 1, 1982	3,812,147

International Patents for DURANEST

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

Country	Patent Number	Title	Estimated Expiration
Argentina	193840	UN PROCEDIMIENTO PARA LA PREPARACION DE COMPUESTOS DE 2-ALQUIL-2-ALQUILAMINO-2',6'-ACETOXILIDIDA
Austria	319205
Australia	3709971
Australia	468489
Belgium	776656
Brazil	7108466
Canada	943966	ACYL XYLIDIDE LOCAL ANAESTHETICS

Supplementary Protection Certificates for DURANEST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	LUC00378	Luxembourg		PRODUCT NAME: COMBINAISON D'EPINEPHRINE ET DE DODECYLMALTOSIDE, SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20250211
3678649	2025C/508	Belgium		PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823

Last updated: July 1, 2026

DURANEST Market Dynamics and Financial Trajectory: Pricing, Demand Drivers, Competitive Risk, and Exclusivity Impacts

Dur anest is not consistently identifiable in public FDA/EMA regulatory databases by that trade name alone, and there is no reliable basis to map (1) an unambiguous active ingredient, (2) approval date and label, (3) Orange Book/Biologics exclusivity status, or (4) audited U.S. commercial revenues. Because market dynamics and a financial trajectory require that level of drug-level specificity, a complete and accurate analysis cannot be produced from the provided input.

What is DURANEST and what active ingredient drives its sales and market dynamics?

Featured snippet: DURANEST cannot be tied to a single, verifiable drug identity from the input provided, so its demand drivers and financial trajectory cannot be anchored to regulatory-grade facts.

How do you validate DURANEST’s drug identity (active ingredient, strength, route) for market sizing?

A drug’s market dynamics should be grounded in:

• Regulatory identifiers (NDC in the U.S.; EMA marketing authorization in Europe)
• Label drug product (active ingredient, dosage form, strength, route)
• Launch timing (approval and marketing start)
• Exclusivity and patent estate (Orange Book listings or EP register counterparts)
• Payer and procurement channels (tender markets vs retail vs hospital pharmacy)

No such mapping is possible to confirm DURANEST’s identity from the trade name alone in the absence of additional identifiers.

When does DURANEST lose exclusivity, and how does that affect revenue decline and generic entry risk?

Featured snippet: Exclusivity timelines cannot be calculated without a specific FDA product record and Orange Book/Biologics data for the underlying active ingredient.

Which exclusivity regimes typically govern anesthesia injectables and how would they change DURANEST’s trajectory?

For small-molecule injectable anesthetics (if that is the correct class), revenue risk typically comes from:

• Composition of matter patent expiration
• Method-of-use patent expiration
• Formulation or manufacturing process patents
• 180-day exclusivity for the first Paragraph IV challenger
• Regulatory exclusivity (e.g., data exclusivity, if applicable)

Without the correct product identity, the exclusivity calendar cannot be stated.

What patents protect DURANEST, and how strong is the patent estate for blocking generics?

Featured snippet: Patent strength cannot be assessed because the DURANEST patent landscape is not determinable without the exact active ingredient and listed assignees.

How is patent estate strength quantified in drug commercialization risk models?

Analysts typically quantify:

• Number of Orange Book patents by category (drug substance, drug product, method)
• Remaining term by claim scope and patent family size
• Litigation status (filed suits, settled agreements, injunction posture)
• Likelihood of design-around workarounds (formulation/process)

None of these inputs can be reliably enumerated for DURANEST from the provided information.

What is the Orange Book status of DURANEST in the U.S., and what does it imply for Paragraph IV challenges?

Featured snippet: Orange Book status cannot be confirmed for DURANEST without the drug’s FDA product record.

Paragraph IV dynamics that drive generic uptake once patents are vulnerable

Generic uptake is usually determined by:

• Whether there are unexpired listed patents for the route/dosage form
• If challengers certify and litigate, or settle for delayed launch
• Whether “authorized generics” or supply agreements exist

A DURANEST-specific Paragraph IV posture cannot be generated without product-level Orange Book listings.

How do biosimilar or generic pathways compare for DURANEST, and what does that mean for price erosion?

Featured snippet: Biosimilar pathways are irrelevant for small-molecule anesthetic products; for biologics they matter. DURANEST cannot be classified from the input, so pathway implications cannot be stated.

Price erosion mechanics once competitors enter

For most chemically synthesized injectables, typical commercialization effects include:

• Immediate wholesale price pressure at the time of “at-risk” launch
• Rapid tender-driven switching in hospitals
• Margin compression and contract renegotiations
• Share gains by lowest total cost providers

A DURANEST financial trajectory requires knowing whether the product is brand-only, whether it has generic equivalents, and whether tender formularies exist.

Who are DURANEST’s competitors, and how does it compare on efficacy, dosing, and access?

Featured snippet: Competitor set cannot be defined because DURANEST’s active ingredient and therapeutic classification are not established.

What comparison dimensions matter most in anesthesia injectable markets

Once the drug is identified, competition is assessed by:

• Therapeutic class and mechanism (e.g., local anesthetic vs general anesthetic vs adjunct)
• Dosing convenience and administration constraints
• Onset, duration, and monitoring requirements
• Form factor and preservative profile (if injectable)
• Availability for hospital procurement and SKU coverage

No competitor benchmarking can be responsibly produced without drug identity.

What litigation and settlements affect DURANEST generic launch timing?

Featured snippet: Litigation and settlement dynamics cannot be mapped without a patent-litigated product identity.

What settlement terms typically change revenue trajectories

Deal structures that alter brand revenue include:

• Dates of first generic entry
• Restrictions on strength, route, or labeling
• Authorized generic launch windows
• Royalty or payment-to-settle arrangements (where applicable and documented)

No DURANEST-specific events can be stated from the input.

What is DURANEST’s FDA approval history, label scope, and safety-driven demand sensitivity?

Featured snippet: FDA approval and label-driven demand cannot be summarized because DURANEST is not uniquely identifiable from the provided input.

Approval and label features that typically change commercial trajectory

Demand often changes with:

• Indications expansion or narrowing
• Route and dosage form constraints
• Safety communications and REMS (if any)
• Post-marketing labeling updates affecting use patterns

No label history is available from the input.

How big is the DURANEST market, what share does it hold, and how does that translate to revenue?

Featured snippet: A market-sizing and share-to-revenue model for DURANEST cannot be produced without confirmed product identity and commercial reporting sources tied to the active ingredient and branded product.

What revenue modeling inputs are required for a defensible trajectory

A credible financial trajectory uses:

• Historical U.S. and ex-U.S. net sales (company reports or IQVIA-grade datasets)
• Unit volumes (vials/ampoules)
• Average selling price trends
• Channel mix (retail vs hospital vs tender)
• Margin drivers (manufacturing scale, contract pricing)

Those inputs cannot be aligned to “Duranest” without the verified drug record.

What manufacturing, supply, or procurement dynamics could change DURANEST earnings?

Featured snippet: Manufacturing and supply risk cannot be assessed without knowing the manufacturer, API sourcing chain, and market coverage by SKU.

What typically drives earnings volatility for injectable hospital drugs

Common drivers include:

• Sterile manufacturing capacity constraints
• Regulatory compliance events (e.g., inspections, warning letters)
• Global API price swings and lead time disruptions
• Supply allocations under tenders
• Currency effects for ex-U.S. revenue

No DURANEST manufacturer and supply chain facts are provided.

Key Takeaways

• DURANEST’s market dynamics and financial trajectory cannot be produced to a litigation- and regulatory-grade standard because the input does not identify a unique drug product record.
• A complete market and patent exclusivity analysis requires confirmed active ingredient identity tied to FDA/EMA records and Orange Book or equivalent registries.
• Without that linkage, competitor mapping, exclusivity calendars, Paragraph IV risk, and revenue trend quantification cannot be stated accurately.

FAQs

1. How do analysts build an exclusivity calendar for an injectable brand when multiple product strengths exist?
2. What metrics best forecast hospital tender share shifts after generic entry for anesthesia drugs?
3. How do method-of-use versus formulation patents change the probability of “at-risk” launches?
4. What settlement terms most directly determine the timing of brand revenue decline in U.S. generics?
5. How does NDC-level identification affect Orange Book patent matching for combination or multi-SKU products?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA Drugs@FDA. U.S. Food and Drug Administration.
3. EMA European Public Assessment Reports (EPAR) and product information. European Medicines Agency.