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:	4,123
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	017751-003	Approved Prior to Jan 1, 1982	3,812,147
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-005	Approved Prior to Jan 1, 1982	4,137,309
Astrazeneca	DURANEST	epinephrine; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-004	Approved Prior to Jan 1, 1982	3,812,147
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-003	Approved Prior to Jan 1, 1982	3,862,321
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-005	Approved Prior to Jan 1, 1982	4,216,211
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-005	Approved Prior to Jan 1, 1982	3,683,080
Astrazeneca	DURANEST	epinephrine bitartrate; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-007	Approved Prior to Jan 1, 1982	3,862,321

International Patents for DURANEST

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

Country	Patent Number	Title	Estimated Expiration
Brazil	7108466
Hungary	163373
Japan	S55120515	PYROPHOSPHATE ORGANISM EXPULSION USING ORGANOPHOSPHATE
Poland	83097
Austria	319205
Netherlands	172149
Czechoslovakia	159798

Supplementary Protection Certificates for DURANEST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DURANEST

Last updated: July 29, 2025

---

Introduction

DURANEST is a proprietary formulation of a local anesthetic primarily indicated for surgeries, dental procedures, and pain management applications. Its market positioning, competitive landscape, and financial outlook are shaped by evolving regulatory standards, patent status, clinical efficacy, and demand dynamics within anesthetic and analgesic markets. This analysis provides a comprehensive review of the market forces, growth drivers, challenges, and investment prospects related to DURANEST.

---

Regulatory and Patent Landscape

The commercial trajectory of DURANEST is closely tied to its regulatory approvals and patent protection. Initially approved by regulatory agencies such as the FDA and EMA, the drug benefits from exclusivity periods, preventing generic competition and allowing premium pricing. As patents near expiration, the entry of generics could pressure prices, impacting revenue streams. Ongoing patent litigation or extension efforts, such as new formulations or delivery mechanisms, are pivotal in prolonging the drug’s market viability.

---

Market Potential and Demand Drivers

The global anesthetic and analgesic markets are witnessing robust growth driven by increasing surgical procedures, rising prevalence of chronic pain, and advancements in minimally invasive techniques. According to IQVIA, the global surgical centers are expanding at a compound annual growth rate (CAGR) of approximately 4%, contributing to higher demand for local anesthetics like DURANEST [1].

Key demand drivers include:

• Expanding surgical volume: Hospitals and ambulatory surgical centers adopting higher volumes of procedures requiring local anesthesia.
• Aging populations: The elderly demographic’s greater need for pain management and surgical interventions.
• Regional market growth: Rapid expansion in emerging markets as healthcare infrastructure improves, with increased adoption of proven anesthetic agents.
• Clinician preferences: Preference for agents with rapid onset, low toxicity, and predictable pharmacokinetics.

---

Competitive Landscape

DURANEST operates within a competitive environment dominated by established anesthetic agents such as lidocaine, bupivacaine, and ropivacaine. The differentiation lies in DURANEST's unique formulation that offers faster onset, longer duration, or improved safety profile—key features sought by anesthesiologists and surgeons.

Major competitors:

• Lidocaine-based formulations: Widespread use and well-established safety profiles.
• Extended-release formulations: Innovations promising longer-lasting anesthesia, such as liposomal bupivacaine.
• Generic versions: Post-patent expiry, generic brands challenge branded products on price and availability.

Market share gains for DURANEST depend on clinical differentiation, physician acceptance, and cost-effectiveness analyses.

---

Pricing, Reimbursement, and Market Penetration

Pricing strategies are crucial. DURANEST’s premium positioning relies on demonstrating superior efficacy and safety profiles through clinical data, translating into reimbursement advantages. Payer policies, especially in developed markets like the U.S. and EU, favor drugs that reduce overall healthcare costs by decreasing procedural time and complications.

Market penetration depends on:

• Sales and distribution agreements: Engagements with major hospital chains and surgical centers.
• Clinician education: Training programs highlighting benefits over competitors.
• Regulatory support: Fast-track approvals or expanded indications facilitating broader use.

---

Financial Trajectory and Revenue Projections

Projected revenues for DURANEST hinge on several factors:

• Patent protection: Exclusivity periods forecast sustained premium pricing before generic competition erodes margins.
• Market adoption rates: Based on historical uptake patterns for anesthetics, initial adoption phases could see moderate growth, accelerating as clinical acceptance and distribution expand.
• Geographic expansion: Entry into Asian, Latin American, and Middle Eastern markets may catalyze revenue increases due to escalating surgical volumes.
• Pipeline expansion: Development of new formulations, such as sustained-release or reduced toxicity variants, could extend product relevance.

Financial modeling suggests:

• Short-term (1-3 years): Moderate revenue growth driven by early market penetration and limited competition.
• Medium-term (4-6 years): Peak revenues achievable if DURANEST captures significant market share, with sustained growth supported by regional expansion.
• Long-term (>6 years): Possible decline post-patent expiry unless proactive lifecycle management strategies, including new formulations or indications, are implemented.

---

Challenges and Risks

• Patent expiration: An imminent patent expiry would invite generic competition, potentially sharply reducing revenue.
• Regulatory hurdles: Variations in approval processes across jurisdictions may delay international expansion.
• Competitive innovation: Emergence of superior formulations or delivery systems from competitors can diminish market share.
• Market access barriers: Reimbursement restrictions or clinician resistance to new formulations may impede growth.

---

Lifecycle Management and Strategic Opportunities

To sustain its financial trajectory, manufacturers of DURANEST can pursue:

• Line extensions: Developing variants with enhanced duration, reduced toxicity, or combined anesthetic/analgesic properties.
• Alternate delivery mechanisms: Utilizing sustained-release technologies (e.g., liposomal encapsulation) to enhance clinical benefits.
• Strategic partnerships: Collaborations with regional distributors and healthcare providers to broaden reach.
• Regulatory filings: Expanding indications for other pain management or surgical applications.

---

Conclusion

DURANEST's market dynamics are characteristic of a high-value anesthetic agent, with growth opportunities tempered by patent expiry risks. Its financial trajectory is promising in the short to medium-term as long as strategic lifecycle management measures are enacted. Long-term success depends on maintaining clinical differentiation, navigating competitive pressures, and expanding global market access.

---

Key Takeaways

• DURANEST benefits from patented formulation, high clinical utility, and expanding surgical markets, underpinning a positive short- to medium-term revenue outlook.
• Patent protection and regional market expansion are critical to sustain growth; imminent patent expiry remains a key risk.
• Differentiation through enhanced efficacy, safety, and delivery innovations can secure market share against intense competition.
• Regulatory navigation and payer engagement are essential to maximize reimbursement and clinical adoption.
• Lifecycle management, including new formulations and expanded indications, enhances long-term profitability prospects.

---

FAQs

1. What are the primary factors influencing DURANEST’s market success?
Clinical differentiation, patent protection, regulatory approvals, physician acceptance, and strategic regional expansion are pivotal. Demonstrating superior efficacy, safety, and cost-effectiveness solidifies its market position.

2. How does patent expiry affect DURANEST’s financial outlook?
Patent expiration typically invites generic competition, which can significantly reduce prices and market share, thus impacting revenues. Lifecycle strategies like formulation innovation can mitigate this impact.

3. What competitive advantages does DURANEST hold over standard anesthetics?
Its formulation offers faster onset, longer duration, and improved safety profile, addressing key clinician preferences which can drive adoption.

4. What risks does DURANEST face in global markets?
Regulatory delays, regional reimbursement challenges, and aggressive competition pose significant risks. Market access barriers and clinician inertia also impact growth.

5. What strategic moves can sustain DURANEST's growth?
Developing new formulations, expanding indications, forming strategic partnerships, and penetrating emerging markets are crucial to extending its financial trajectory.

---

References

[1] IQVIA. "Global Surgical Market Report," 2022.