Details for Patent: 8,759,401

Which drugs does patent 8,759,401 protect, and when does it expire?

Patent 8,759,401 protects AKTEN and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 8,759,401

Title:	Aqueous gel formulation and method for inducing topical anesthesia
Abstract:	Disclosed is a stable aqueous gel formulation suitable for topical use comprising water, an anesthetic (e.g., lidocaine hydrochloride), a viscoelastic polymer, and a tonicity modifier, wherein the aqueous gel formulation is free of preservatives and phosphate buffer, is isotonic with physiological fluids, and is sterile and has low particulate count. Also disclosed is a method of inducing topical anesthesia on a tissue or organ, e.g., the eye, of an animal comprising providing a stable aqueous gel formulation comprising water, an anesthetic, a viscoelastic polymer, and a tonicity modifier, wherein the aqueous gel formulation is free of preservatives and phosphate buffer, is isotonic with physiological fluids, and is sterile, and topically administering an effective amount of the aqueous gel formulation to the tissue or organ of the animal.
Inventor(s):	Alam; Abu (Lake Forest, IL), Reichel; Elias (Weston, MA), Busbee; Brandon (Nashville, TN)
Assignee:	Akorn, Inc. (Lake Forest, IL)
Application Number:	13/961,453
Patent Claim Types: see list of patent claims	Formulation; Compound; Use;

United States Patent 8,759,401: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,759,401, titled "Aqueous gel formulation and method for inducing topical anesthesia," is a significant patent in the field of medical science, particularly in the realm of topical anesthetics. This patent, issued to Akorn, Inc. (now assigned to Thea Pharma), covers a specific formulation and method for inducing topical anesthesia.

Patent Overview

Inventors and Assignees

The patent was invented by Alam Abu, Elias Reichel, and Brandon Busbee, and it is assigned to Thea Pharma, having been originally assigned to Akorn, Inc.[1][2].

Issue Date and Expiry

The patent was issued on June 24, 2014, and it is set to expire on July 24, 2026, unless any extensions or amendments are made[2].

Scope of the Patent

Aqueous Gel Formulation

The patent describes a stable aqueous gel formulation designed for topical use. This formulation includes water, an anesthetic such as lidocaine hydrochloride, a viscoelastic polymer, and a tonicity agent. The combination of these components ensures effective topical anesthesia while maintaining the stability and viscosity of the gel[4][5].

Method for Inducing Topical Anesthesia

The method outlined in the patent involves applying the aqueous gel formulation to the skin or mucous membranes to induce topical anesthesia. This method is particularly useful for procedures requiring local pain relief without the need for injections[4].

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims cover the specific composition of the aqueous gel, the method of preparation, and the application of the gel for inducing topical anesthesia. For instance, Claim 1 describes the aqueous gel formulation comprising water, lidocaine hydrochloride, a viscoelastic polymer, and a tonicity agent[4].

Dependent Claims

Dependent claims further specify the details of the independent claims, such as the concentration of the anesthetic, the type of viscoelastic polymer used, and the pH range of the formulation. These claims help to narrow down the scope and ensure that the invention is clearly defined[4].

Patent Landscape

Related Patents

The patent landscape for topical anesthetics includes several related patents, particularly those involving lidocaine hydrochloride. For example, patents related to the Zingo device, which delivers powdered lidocaine hydrochloride for topical anesthesia, have various expiry dates ranging from 2029 to 2035[2].

Generic Availability

Currently, there is no generic version of Akten available in the United States. The exclusivity period and patent protection ensure that Thea Pharma maintains sole marketing rights until the patent expires in 2026[1].

Legal Activities and Patent Maintenance

The life of a patent can be affected by various legal activities such as maintenance fee payments, term extensions, and amendments to claims. For US8759401B2, regular maintenance fees have been paid to keep the patent active. Any changes in these activities could impact the expiry date and the potential for generic versions[2].

Impact on Innovation and Market

Innovation Incentives

The patent system is designed to incentivize innovation by granting exclusive rights to the patent holder. However, overly broad or unclear patents can lead to increased licensing and litigation costs, potentially diminishing innovation incentives. The scope and claims of US8759401B2 are specific and well-defined, which helps in maintaining a balance between innovation and competition[3].

Market Competition

The absence of a generic version of Akten until 2026 means that Thea Pharma enjoys a monopoly in the market for this specific aqueous gel formulation. This can impact market competition and prices. Once the patent expires, other manufacturers may enter the market with generic versions, potentially increasing competition and reducing prices[1].

Technical and Practical Applications

Medical Procedures

The aqueous gel formulation described in the patent is particularly useful for various medical procedures that require local anesthesia, such as minor surgeries, dermatological treatments, and ophthalmic procedures. The ease of application and effectiveness of the gel make it a valuable tool in clinical settings[4].

Patient Comfort

The method of inducing topical anesthesia using this gel formulation enhances patient comfort by providing effective pain relief without the need for injections. This is especially beneficial for patients who fear needles or have sensitive skin[4].

Regulatory and Legal Considerations

FDA Exclusivity

In addition to patent protection, the FDA grants exclusivity periods to drug manufacturers. For Akten, any FDA exclusivity would run concurrently with the patent, further protecting the market position of Thea Pharma until the exclusivity period ends[1].

Patent Litigation

Changes in patent claims or disputes over patent infringement can affect the patent's validity and expiry date. Monitoring legal activities related to the patent is crucial for understanding the potential for early generic entry or extended market exclusivity[2].

Conclusion

United States Patent 8,759,401 is a critical patent in the field of topical anesthesia, covering a specific aqueous gel formulation and its method of application. The patent's scope and claims are well-defined, ensuring that Thea Pharma maintains exclusive rights until the patent expires in 2026. Understanding the patent landscape, legal activities, and regulatory considerations is essential for both innovators and competitors in the pharmaceutical industry.

Key Takeaways

• Patent Scope: The patent covers a stable aqueous gel formulation for topical anesthesia.
• Claims: Specific claims define the composition and method of application.
• Expiry Date: The patent is set to expire on July 24, 2026.
• Generic Availability: No generic version is currently available.
• Innovation and Market: The patent incentivizes innovation but also affects market competition.
• Technical Applications: The formulation is useful for various medical procedures.
• Regulatory Considerations: FDA exclusivity and patent litigation can impact the patent's validity.

Frequently Asked Questions

1. What is the main subject of United States Patent 8,759,401?

The main subject is an aqueous gel formulation and method for inducing topical anesthesia.

2. Who are the inventors of this patent?

The inventors are Alam Abu, Elias Reichel, and Brandon Busbee.

3. When is the patent set to expire?

The patent is set to expire on July 24, 2026.

4. Is there a generic version of Akten available?

No, there is currently no generic version of Akten available in the United States.

5. How does the patent impact market competition?

The patent grants exclusive marketing rights to Thea Pharma until its expiry, affecting market competition and prices.

Cited Sources

1. Drugs.com: Generic Akten Availability.
2. Pharsight: Drug Patents containing Lidocaine Hydrochloride.
3. Hoover Institution: Patent Claims and Patent Scope.
4. Google Patents: Aqueous gel formulation and method for inducing topical anesthesia.
5. PubChem: Aqueous gel formulation and method for inducing topical anesthesia.

Drugs Protected by US Patent 8,759,401

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Thea Pharma	AKTEN	lidocaine hydrochloride	GEL;OPHTHALMIC	022221-001	Oct 7, 2008		RX	Yes	Yes	8,759,401		Y			METHOD OF INDUCING TOPICAL ANESTHESIA IN THE EYE

International Family Members for US Patent 8,759,401

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2043601
World Intellectual Property Organization (WIPO)	2008014036