ORAVERSE Drug Patent Profile

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

Oraverse is a drug marketed by Septodont Holding and is included in one NDA.

The generic ingredient in ORAVERSE is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oraverse

A generic version of ORAVERSE was approved as phentolamine mesylate by HIKMA on March 11^th, 1998.

Summary for ORAVERSE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	6
Patent Applications:	1,054
Drug Prices:	Drug price information for ORAVERSE
What excipients (inactive ingredients) are in ORAVERSE?	ORAVERSE excipients list
DailyMed Link:	ORAVERSE at DailyMed

See drug prices for ORAVERSE

Recent Clinical Trials for ORAVERSE

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

Sponsor	Phase
Cairo University	Phase 3
sara nabil	Phase 3
Dalhousie University	Phase 4

See all ORAVERSE clinical trials

Pharmacology for ORAVERSE

Drug Class	alpha-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists

US Patents and Regulatory Information for ORAVERSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes

Expired US Patents for ORAVERSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	6,764,678
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	7,575,757
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	7,569,230
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	6,872,390
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	7,229,630

International Patents for ORAVERSE

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	522930	Local anesthetic methods and kits
Japan	2010280702	STABILIZED FORMULATION OF ALPHA ADRENERGIC RECEPTOR ANTAGONISTS AND USE THEREOF
Spain	2281418
World Intellectual Property Organization (WIPO)	2004000219
Cyprus	1107617
World Intellectual Property Organization (WIPO)	0185171
Slovenia	1280531

ORAVERSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OraVerse

Introduction to OraVerse

OraVerse, containing the active ingredient phentolamine mesylate, is a groundbreaking drug in the dental industry, specifically designed to reverse soft-tissue anesthesia. This alpha-adrenergic blocker is the first therapeutic agent approved by the U.S. Food and Drug Administration (FDA) for this purpose, marking a significant advancement in dental care[2][4].

Development and FDA Approval

Developed by Novalar Pharmaceuticals, OraVerse underwent rigorous clinical trials before receiving FDA approval in May 2008. These trials included Phase III double-blinded, randomized, multicenter, controlled studies that demonstrated the safety and efficacy of phentolamine mesylate in reversing mandibular and maxillary soft-tissue anesthesia. The drug was subsequently marketed in February 2009[2][5].

Clinical Efficacy

Clinical trials have shown that OraVerse significantly hastens the return of normal soft-tissue sensation. Patients who received OraVerse experienced a return to normal sensation and function in about half the time compared to those who did not receive the drug. Specifically, median lip recovery times were reduced by 75 to 85 minutes. This rapid reversal also resolved functional deficits such as drooling, difficulty in drinking, smiling, or talking, and subjects' perception of altered function or appearance[1][2].

Market Acquisition and Distribution

In a significant move, Septodont acquired the OraVerse product line from Novalar Pharmaceuticals. This acquisition included all sales, marketing, and regulatory responsibilities for Septodont's North American and unpartnered international markets. Septodont, with its established dealer relationships, manufacturing expertise, and complementary product lines (such as Septocaine), is well-positioned to take OraVerse to the next level[2].

Financial Implications of the Acquisition

The acquisition deal involved an upfront payment to Novalar and its investors, along with milestones and royalties on product sales. While the exact financial terms were not disclosed, the acquisition is expected to boost the market presence of OraVerse. Septodont's resources and existing market presence are likely to enhance the drug's adoption and sales[2].

Market Compatibility and Integration

OraVerse fits seamlessly into Septodont's portfolio of dental products, particularly due to its compatibility with Septocaine, a leading proprietary brand of Septodont. This integration is expected to leverage Septodont's extensive distribution network and marketing capabilities, further expanding the reach of OraVerse[2].

Clinical Use and Patient Feedback

Dentists and patients have responded favorably to OraVerse. The drug's ability to quickly reverse anesthesia has improved patient care by reducing the duration of post-procedure numbness and associated functional deficits. However, the cost of the agent may influence its widespread adoption into clinical practice[1].

Safety and Adverse Reactions

Clinical trials have shown that OraVerse is safe and effective for adults and children 6 years of age and older, weighing 33 pounds or more. Adverse reactions were generally mild and resolved within 48 hours, with no serious adverse events reported. Common adverse reactions included tachycardia, bradycardia, injection site pain, and post-procedural pain, but these were comparable to or only slightly higher than those in the control groups[1][4].

Market Impact and Growth

The introduction of OraVerse has marked a new therapeutic class in dentistry, addressing a long-standing issue of prolonged anesthesia. As more dentists adopt this drug, it is expected to drive growth in the dental pharmaceutical market. The acquisition by Septodont is likely to accelerate this growth by leveraging their extensive resources and market presence[2].

Competitive Landscape

OraVerse is currently the only FDA-approved drug for reversing soft-tissue anesthesia, giving it a unique position in the market. However, the dental pharmaceutical market is competitive, with other companies developing new products and technologies. Septodont's strong presence and the compatibility of OraVerse with other leading products will be crucial in maintaining its market share[2].

Future Prospects

Given its clinical efficacy and the strong support from both dentists and patients, OraVerse is poised for continued growth. As more dental practices adopt this drug, it is likely to become a standard tool in post-procedure care. The financial trajectory of OraVerse will likely be positive, driven by increased adoption and sales facilitated by Septodont's resources[2].

Key Takeaways

• FDA Approval: OraVerse was approved by the FDA in May 2008 for reversing soft-tissue anesthesia.
• Clinical Efficacy: The drug significantly reduces the duration of post-procedure numbness and associated functional deficits.
• Acquisition: Septodont acquired OraVerse from Novalar Pharmaceuticals, enhancing its market presence.
• Safety: OraVerse has been shown to be safe with mild and temporary adverse reactions.
• Market Impact: It has introduced a new therapeutic class in dentistry and is expected to drive growth in the dental pharmaceutical market.
• Future Prospects: Continued adoption and sales are anticipated, driven by its clinical efficacy and Septodont's resources.

FAQs

Q: What is OraVerse used for? A: OraVerse is used to reverse soft-tissue anesthesia, specifically the numbing sensation associated with local anesthetics in dental procedures.

Q: Who developed OraVerse? A: OraVerse was developed by Novalar Pharmaceuticals.

Q: Who acquired OraVerse from Novalar Pharmaceuticals? A: Septodont acquired the OraVerse product line from Novalar Pharmaceuticals.

Q: What are the common adverse reactions associated with OraVerse? A: Common adverse reactions include tachycardia, bradycardia, injection site pain, and post-procedural pain, but these are generally mild and temporary.

Q: Is OraVerse safe for children? A: Yes, OraVerse is safe and effective for children 6 years of age and older, weighing 33 pounds or more.

Sources

1. Phentolamine mesylate (OraVerse), a nonselective a-adrenergic blocking drug... - PubMed
2. Septodont acquires OraVerse from Novalar - DrBicuspid.com
3. How does news affect biopharma stock prices?: An event study - PLOS ONE
4. OraVerse (Phentolamine Mesylate Injection): Side Effects, Uses... - RxList
5. Local Anesthesia Reversal - OraVerse - OraVerse.com