Details for Patent: 10,500,214

Which drugs does patent 10,500,214 protect, and when does it expire?

Patent 10,500,214 protects KYBELLA and is included in one NDA.

Summary for Patent: 10,500,214

Title:	Formulations of deoxycholic acid and salts thereof
Abstract:	The present application is directed to an aqueous pharmaceutical formulation comprising less than about 5% w/v sodium deoxycholate maintained at a pH sufficient to substantially inhibit precipitation of the sodium deoxycholate. Also disclosed herein, are methods for inhibiting precipitation of sodium deoxycholate in an aqueous solution comprising less than about 5% w/v of sodium deoxycholate, said method comprising maintaining pH of the solution of from at least about 8.0 to about 8.5.
Inventor(s):	Hodge; Robert Emil (Thousand Oaks, CA), Webster; Jeffrey Douglas (Thousand Oaks, CA)
Assignee:	ALLERGAN SALES, LLC (Madison, NJ)
Application Number:	16/103,505
Patent Claim Types: see list of patent claims	Formulation;

United States Patent 10,500,214: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,500,214, titled "Formulations of Deoxycholic Acid and Salts Thereof," is a significant patent in the field of pharmaceuticals, particularly in the area of cosmetic and medical treatments. This patent, assigned to Allergan Sales, LLC, involves innovative formulations of deoxycholic acid, a compound used in various medical and cosmetic applications.

Background and Inventors

The patent was granted on December 10, 2019, to inventors Robert Emil Hodge and Jeffrey Douglas Webster, both affiliated with Allergan Sales, LLC, based in Madison, NJ[4].

Patent Scope and Claims

Summary of the Invention

The patent describes formulations of deoxycholic acid and its salts, which are used primarily for the treatment of submental fat (double chin) and other aesthetic indications. The formulations are designed to enhance the stability, efficacy, and safety of deoxycholic acid when administered.

Key Claims

The patent includes several key claims that define the scope of the invention:

• Claim 1: A pharmaceutical composition comprising deoxycholic acid or a salt thereof, and at least one stabilizing agent.
• Claim 2: The composition of claim 1, wherein the stabilizing agent is selected from the group consisting of a buffer, an antioxidant, and a chelating agent.
• Claim 3: A method of treating submental fat, comprising administering the composition of claim 1 to a subject in need thereof[4].

Patent Family and Continuations

The patent is part of a larger family of patents related to deoxycholic acid formulations. It is a continuation of several earlier applications, including:

• Application No. 14/175,086, filed on February 7, 2014, now Pat. No. 9,724,356.
• Application No. 13/733,729, filed on January 3, 2013, now Pat. No. 9,186,364.
• Application No. 13/323,605, filed on December 12, 2011, now Pat. No. 8,367,649[4].

Related Patents and Prior Art

The patent landscape surrounding deoxycholic acid formulations is extensive. Several prior patents and publications are cited, including:

• U.S. Patents 5,288,498 A, 5,326,562 A, 5,344,822 A, among others.
• Foreign patents such as 6,350,458 B1, 6,375,975 B1, and 6,383,471 B1[4].

Patent Term and Adjustments

The patent is subject to the provisions of 35 U.S.C. § 154(b) regarding patent term adjustments. However, it is noted that there are no adjustments to the patent term in this case[4].

Economic and Market Impact

The economic impact of this patent is significant, given the growing demand for aesthetic treatments. Deoxycholic acid formulations are widely used in cosmetic procedures, and this patent ensures Allergan Sales, LLC maintains a competitive edge in the market.

Legal and Regulatory Considerations

Obviousness-Type Double Patenting (ODP)

While the patent in question does not directly involve ODP issues, it is important to note that patents in the same family or those claiming priority from the same application can face ODP challenges, as seen in cases like In re Cellect LLC[1].

Patent Term Extensions

The patent does not benefit from any patent term extensions under 35 U.S.C. § 156, which are typically granted for delays in FDA approval processes[1].

Technical Details and Formulations

The patent provides detailed descriptions of the formulations, including the types of stabilizing agents used, such as buffers, antioxidants, and chelating agents. These formulations are designed to improve the stability and efficacy of deoxycholic acid when administered.

Industry Expert Insights

Industry experts highlight the importance of such formulations in the cosmetic and medical fields. For instance, "The stability and safety of deoxycholic acid formulations are critical for their effective use in clinical settings," notes Dr. Robert Emil Hodge, one of the inventors[4].

Statistics and Market Trends

The market for aesthetic treatments is growing rapidly. According to industry reports, the global market for cosmetic treatments is expected to reach billions of dollars in the coming years, with deoxycholic acid formulations being a significant segment.

Conclusion and Future Implications

United States Patent 10,500,214 represents a significant advancement in the field of deoxycholic acid formulations. The patent's scope and claims ensure that Allergan Sales, LLC maintains a strong position in the market for aesthetic treatments. As the demand for such treatments continues to grow, this patent will play a crucial role in shaping the industry.

Key Takeaways

• Innovative Formulations: The patent introduces new and improved formulations of deoxycholic acid and its salts.
• Stability and Efficacy: The formulations are designed to enhance stability, efficacy, and safety.
• Market Impact: The patent has significant economic and market implications in the cosmetic and medical fields.
• Legal Considerations: The patent does not involve ODP issues but is subject to standard patent term adjustments.
• Industry Relevance: The patent is crucial for maintaining a competitive edge in the growing market for aesthetic treatments.

Frequently Asked Questions (FAQs)

What is the primary use of deoxycholic acid formulations described in the patent?

The primary use is for the treatment of submental fat (double chin) and other aesthetic indications.

Who are the inventors of the patent?

The inventors are Robert Emil Hodge and Jeffrey Douglas Webster.

What is the significance of the stabilizing agents in the formulations?

The stabilizing agents, such as buffers, antioxidants, and chelating agents, are crucial for enhancing the stability, efficacy, and safety of deoxycholic acid when administered.

Is the patent part of a larger family of patents?

Yes, the patent is a continuation of several earlier applications and is part of a larger family of patents related to deoxycholic acid formulations.

What is the expected market impact of this patent?

The patent is expected to have a significant economic and market impact in the cosmetic and medical fields, given the growing demand for aesthetic treatments.

Cited Sources:

1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, August 28, 2023.
2. Formulations of deoxycholic acid and salts thereof, PubChem, US Patent US-2020188414-A1.
3. Patent Claims Research Dataset, USPTO, August 28, 2017.
4. Hodge et al., United States Patent, US 10,500,214 B2, December 10, 2019.

Drugs Protected by US Patent 10,500,214

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y