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Last Updated: December 22, 2024

Details for Patent: 7,399,488


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Summary for Patent: 7,399,488
Title:Abuse-deterrent pharmaceutical compositions of opiods and other drugs
Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, a drug is modified to increase its lipophilicity. In preferred embodiments the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble, but enzymatically degradable by enzymes present in the human gastrointestinal tract. The abuse-deterrent composition retards the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion.
Inventor(s): Hirsh; Jane (Wellesley, MA), Kibanov; Alexander M. (Newton, MA), Swager; Timothy M. (Newton, MA), Buchwald; Stephen L. (Newton, MA), Lo; Whe Yong (Canton, MA), Fleming; Alison B. (Marshfield, MA), Rariy; Roman V. (Allston, MA)
Assignee: Collegium Pharmaceutical, Inc. (Cumberland, RI)
Application Number:10/614,866
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,399,488
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

United States Patent 7,399,488: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,399,488, titled "Controlled Release Formulation of a Pharmaceutical Composition," was granted on July 15, 2008, to inventors associated with Collegium Pharmaceutical Inc. This patent is significant in the field of pharmaceuticals, particularly for controlled release formulations. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background and Invention Overview

The patent 7,399,488 pertains to a controlled release formulation of a pharmaceutical composition, specifically designed to manage the release of active pharmaceutical ingredients over an extended period. This technology is crucial for improving patient compliance and reducing the frequency of dosing.

Scope of the Patent

The scope of the patent encompasses a specific formulation design that ensures the controlled release of the active pharmaceutical ingredient. Here are the key aspects:

Formulation Composition

The formulation includes a combination of immediate release and controlled release components. The immediate release component provides an initial dose, while the controlled release component ensures a sustained release of the active ingredient over time.

Controlled Release Mechanism

The controlled release mechanism is achieved through the use of specific polymers and excipients that regulate the release rate of the active ingredient. This mechanism is designed to maintain therapeutic levels of the drug in the body for an extended period.

Claims of the Patent

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

Independent Claims

  • Claim 1 describes the pharmaceutical composition comprising an immediate release component and a controlled release component.
  • Claim 5 details the method of preparing the formulation, including the steps of mixing the active ingredient with the polymers and excipients.

Dependent Claims

  • Dependent claims further specify the types of polymers and excipients used, the ratio of immediate to controlled release components, and the method of administration.

Patent Landscape

The patent landscape surrounding controlled release formulations is highly competitive and densely populated.

Prior Art and Related Patents

Several prior patents and publications have addressed controlled release formulations, including those by Kaiko et al. (US 6,475,494 B2) and Palermo et al. (US 6,627,635 B2). These patents describe various mechanisms for achieving controlled release, such as the use of different polymers and coating techniques[1].

Competing Technologies

Companies like Paladin Labs Inc. have also developed formulations with decreased abuse potential, which is another critical aspect in the pharmaceutical industry, especially for opioids and other controlled substances[1].

International Patent Filings

The global patent landscape for controlled release formulations is extensive, with filings in multiple jurisdictions. Tools like the Global Dossier and Common Citation Document (CCD) facilitate the search and analysis of related patent applications across different IP offices[4].

Economic and Market Impact

The economic impact of this patent is significant, as it provides a competitive edge in the market for controlled release formulations. The ability to manage the release of pharmaceuticals over an extended period can lead to improved patient outcomes, increased compliance, and reduced healthcare costs.

Market Dominance

Companies holding such patents can dominate the market by offering superior formulations that meet the needs of both patients and healthcare providers. For instance, Collegium Pharmaceutical Inc.'s DETERx™ technology, which is related to this patent, has received notices of allowance for its tamper-resistant, extended-release formulations[5].

Legal and Regulatory Aspects

The patent is subject to various legal and regulatory requirements.

Maintenance Fees and Expiration

To maintain the patent, the assignee must pay periodic maintenance fees. Failure to do so can result in the patent expiring prematurely[2].

Patent Litigation and Enforcement

The patent holder must be vigilant in enforcing their rights against potential infringers. This involves monitoring the market for similar products and taking legal action when necessary[2].

Technological Trends and Future Directions

The field of controlled release formulations is continuously evolving with advancements in materials science and pharmaceutical technology.

New Materials and Techniques

Research is ongoing to develop new polymers and excipients that can further enhance the controlled release mechanism. Nanotechnology and 3D printing are also being explored for their potential in creating complex release profiles[3].

Personalized Medicine

The future may see more personalized controlled release formulations tailored to individual patient needs, leveraging data from genetic profiling and other personalized medicine approaches.

Key Takeaways

  • Controlled Release Formulation: The patent 7,399,488 describes a specific formulation for controlled release of pharmaceuticals.
  • Scope and Claims: The patent includes claims for the composition, method of preparation, and administration.
  • Patent Landscape: The landscape is competitive, with numerous related patents and ongoing research.
  • Economic Impact: The patent provides a competitive edge and potential market dominance.
  • Legal and Regulatory: Maintenance fees and enforcement are crucial for patent validity.

Frequently Asked Questions (FAQs)

Q: What is the primary focus of United States Patent 7,399,488?

A: The primary focus is on a controlled release formulation of a pharmaceutical composition.

Q: Who are the inventors and assignees of this patent?

A: The inventors are associated with Collegium Pharmaceutical Inc., which is also the assignee.

Q: How does the controlled release mechanism work?

A: The mechanism involves the use of specific polymers and excipients to regulate the release rate of the active pharmaceutical ingredient.

Q: What are the economic benefits of this patent?

A: The patent can lead to improved patient outcomes, increased compliance, and reduced healthcare costs, providing a competitive edge in the market.

Q: How can one search for related patents in this field?

A: Tools like the Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used to search for related patent applications[4].

Cited Sources

  1. Vinson et al. US 8,460,640 B2, "Narcotic Drug Formulations With Decreased Abuse Potential," June 11, 2013.
  2. USPTO. "Patents - USPTO," October 9, 2019.
  3. USPTO. "Patent Claims Research Dataset," August 28, 2017.
  4. USPTO. "Search for patents - USPTO," October 18, 2018.
  5. FierceBiotech. "Collegium Pharmaceutical Inc. Announces Notice of Allowance for Second DETERx™ Technology," accessed December 20, 2024.

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Drugs Protected by US Patent 7,399,488

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-001 Apr 26, 2016 RX Yes No 7,399,488 ⤷  Subscribe Y ⤷  Subscribe
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-002 Apr 26, 2016 RX Yes No 7,399,488 ⤷  Subscribe Y ⤷  Subscribe
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-003 Apr 26, 2016 RX Yes No 7,399,488 ⤷  Subscribe Y ⤷  Subscribe
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-004 Apr 26, 2016 RX Yes No 7,399,488 ⤷  Subscribe Y ⤷  Subscribe
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-005 Apr 26, 2016 RX Yes Yes 7,399,488 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 7,399,488

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2003247876 ⤷  Subscribe
Canada 2491572 ⤷  Subscribe
Canada 2569958 ⤷  Subscribe
Canada 2916869 ⤷  Subscribe
Cyprus 1119831 ⤷  Subscribe
Denmark 1765292 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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