ORAQIX Drug Patent Profile

Which patents cover Oraqix, and when can generic versions of Oraqix launch?

Oraqix is a drug marketed by Dentsply Pharm and is included in one NDA.

The generic ingredient in ORAQIX is lidocaine; prilocaine. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oraqix

A generic version of ORAQIX was approved as lidocaine; prilocaine by FOUGERA PHARMS on August 18^th, 2003.

Summary for ORAQIX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Applications:	100
Drug Prices:	Drug price information for ORAQIX
What excipients (inactive ingredients) are in ORAQIX?	ORAQIX excipients list
DailyMed Link:	ORAQIX at DailyMed

See drug prices for ORAQIX

Recent Clinical Trials for ORAQIX

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

Sponsor	Phase
Joanneum Research Forschungsgesellschaft mbH	N/A
Dentsply International	Phase 4

See all ORAQIX clinical trials

Pharmacology for ORAQIX

Drug Class	Amide Local Anesthetic Antiarrhythmic
Physiological Effect	Local Anesthesia

US Patents and Regulatory Information for ORAQIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dentsply Pharm	ORAQIX	lidocaine; prilocaine	GEL;PERIODONTAL	021451-001	Dec 19, 2003		RX	Yes	Yes

Expired US Patents for ORAQIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dentsply Pharm	ORAQIX	lidocaine; prilocaine	GEL;PERIODONTAL	021451-001	Dec 19, 2003	6,031,007

EU/EMA Drug Approvals for ORAQIX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Recordati Ireland Ltd.	Fortacin	lidocaine, prilocaine	EMEA/H/C/002693 Treatment of primary premature ejaculation in adult men.	Authorised	no	no	no	2013-11-15
Plethora Pharma Solutions Limited	Senstend	lidocaine, prilocaine	EMEA/H/C/005298 Senstend is indicated for the treatment of primary premature ejaculation in adult men.	Withdrawn	no	no	no	2019-11-14

International Patents for ORAQIX

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0833612	NOUVELLE COMPOSITION PHARMACEUTIQUE POSSEDANT UN EFFET ANESTHESIQUE (NEW PHARMACEUTICAL COMPOSITION WITH ANAESTHETIC EFFECT)
Estonia	9700363
Australia	716540
Indonesia	16420
Denmark	0833612
Japan	H11501678

ORAQIX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oraqix

Introduction

Oraqix, a periodontal gel containing a eutectic mixture of lidocaine and prilocaine, is a significant player in the dental anesthetic market. This article delves into the market dynamics and financial trajectory of Oraqix, providing insights into its position, growth prospects, and challenges.

Market Context: Dental Anesthetics

The global dental anesthetic market is experiencing steady growth, driven by increasing demand for dental procedures and advancements in product delivery methods. As of 2022, the global dental anesthetic market was valued at $983.5 million and is projected to grow at a CAGR of 6.5% to reach nearly $1.5 billion by 2029[1].

Product Overview: Oraqix

Oraqix is an amide local anesthetic indicated for adults requiring localized anesthesia in periodontal pockets during scaling and/or root planing procedures. It is a microemulsion gel containing 2.5% lidocaine and 2.5% prilocaine[3][4].

Market Position

Oraqix is part of the product portfolio of Dentsply Sirona, one of the key players in the global dental anesthetic market. Dentsply Sirona acquired a notable market share in the dental anesthetics business, with Oraqix being one of its prominent products alongside other local injection brands like Xylocaine and Articadent[1].

Competitive Landscape

The dental anesthetic market is competitive, with major players including Septodont, Dentsply Sirona, and Pierrel Pharma. Septodont leads the market with a diverse array of anesthetic products, while Dentsply Sirona's portfolio, including Oraqix, contributes significantly to its market share. Pierrel Pharma also competes with its Orabloc injectable articaine product[1].

Market Drivers

Several factors drive the demand for Oraqix and similar dental anesthetics:

• Increasing Demand for Dental Procedures: The growing aging population and the need for restorative dental procedures sustain the demand for dental anesthetics.
• Product Innovation: Improvements in delivery methods, such as needleless syringes and spray anesthetics, enhance the appeal of topical anesthetics like Oraqix[1].

Financial Performance

While Oraqix is not separately reported in financial statements, its performance can be inferred from the broader context of Dentsply Sirona's and similar companies' financials.

Revenue Trends

Dentsply Sirona's financial performance is indicative of the market trends. However, specific revenue figures for Oraqix are not publicly disclosed. The overall dental anesthetic market growth suggests that products like Oraqix contribute to the increasing revenues in this segment[1].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the dental industry. While elective procedures were delayed, the long-term demand for dental care remained robust. Companies like OraSure Technologies, which are not directly related to Oraqix but operate in the healthcare diagnostics sector, saw significant declines in COVID-19 related revenues but stable core revenues. This trend might reflect the resilience of the dental anesthetic market during the pandemic[2].

Clinical and Safety Profile

Oraqix has been studied in various clinical trials to assess its safety and efficacy. Key findings include:

• Adverse Events: Common adverse events include local reactions such as pain, soreness, and irritation in the oral cavity. Systemic adverse effects are rare but can include CNS and cardiovascular symptoms[4].
• Pharmacokinetics: The plasma levels of lidocaine and prilocaine after Oraqix administration are well-documented, with mean Cmax values indicating safe and effective anesthesia[3][4].

Regulatory and Safety Considerations

Oraqix is approved for use in several international markets, including the U.S., Canada, and various European countries. The FDA label highlights the potential for systemic toxicity, particularly CNS and cardiovascular effects, although these are rare at the recommended doses[3][4].

Geriatric Use

Clinical studies have shown no significant differences in safety or effectiveness between elderly and younger patients. However, dose selection for elderly patients should be cautious due to potential decreased hepatic, renal, or cardiac function[4].

Future Prospects

The future of Oraqix looks promising due to several factors:

• Market Growth: The increasing demand for dental procedures and the aging population will continue to drive the market.
• Innovation: Advances in delivery methods and product formulation are expected to enhance the market position of Oraqix and similar products[1].

Challenges

Despite the positive outlook, there are challenges to consider:

• Competition: The dental anesthetic market is highly competitive, with multiple players vying for market share.
• Regulatory Scrutiny: Continuous monitoring and compliance with regulatory requirements are essential to maintain market approval and safety standards[1][4].

Key Takeaways

• Market Growth: The global dental anesthetic market is growing, driven by increasing demand for dental procedures.
• Product Position: Oraqix is a significant product in Dentsply Sirona's portfolio, contributing to the company's market share.
• Clinical Profile: Oraqix has a well-documented safety and efficacy profile, with rare systemic adverse effects.
• Future Prospects: The market is expected to grow, driven by demographic changes and product innovations.

FAQs

What is Oraqix used for?

Oraqix is used for localized anesthesia in periodontal pockets during scaling and/or root planing procedures.

Who are the key players in the dental anesthetic market?

The key players include Septodont, Dentsply Sirona, and Pierrel Pharma.

What are the common adverse events associated with Oraqix?

Common adverse events include local reactions such as pain, soreness, and irritation in the oral cavity.

How does the aging population impact the demand for Oraqix?

The growing aging population increases the demand for restorative dental procedures, thereby sustaining the demand for dental anesthetics like Oraqix.

What are the regulatory considerations for Oraqix?

Oraqix is approved for use in several international markets, and its use must comply with FDA and other regulatory guidelines to ensure safety and efficacy.

Sources

1. idataresearch.com: Dental Anesthetic Market & Trends Analysis | Global | 2023 - 2029
2. OraSure Technologies: OraSure Reports Q3 '24 Revenue of $39.9 Million
3. FDA: Oraqix - accessdata.fda.gov
4. Drugs.com: Oraqix: Package Insert / Prescribing Information - Drugs.com