United States Patent 9,198,925: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 9,198,925, titled "Pharmaceutical formulations containing an SGLT2 inhibitor," is a significant patent in the pharmaceutical industry, particularly for the drug dapagliflozin. This patent is part of the broader intellectual property landscape surrounding dapagliflozin, a medication used primarily for the treatment of type 2 diabetes, chronic kidney disease, and heart failure.
Patent Details
- Publication Number: US9198925B2
- Publication Date: October 4, 2015
- Expiration Date: October 4, 2020[2][5].
Scope of the Patent
Medicinal Preparations
The patent focuses on pharmaceutical formulations that include dapagliflozin or its derivatives, specifically in the form of capsules or tablets for oral use. These formulations are characterized by their special physical form, which includes various excipients and inactive ingredients to enhance stability, bioavailability, and patient compliance[1].
Physical Forms
The patent covers a range of physical forms, including:
- Particulate Forms: Such as powders, granulates, and microspheres.
- Solid Products: Obtained through processes like spray drying, spray freeze drying, and spray congealing.
- Capsules and Tablets: Specifically designed for oral administration, often using gelatin or other materials for encapsulation[1].
Excipients and Inactive Ingredients
The patent details the use of various excipients and inactive ingredients, such as:
- Propylene Glycol: Used to enhance the solubility and stability of the active ingredient.
- Cellulose Derivatives: Like hydroxypropyl methylcellulose, which are used as binders or coating agents.
- Other Excipients: Including fillers, lubricants, and disintegrants to ensure proper tablet or capsule function[1].
Claims of the Patent
Composition and Formulation Claims
The patent claims cover the specific compositions and formulations of dapagliflozin, including:
- Active Ingredient: Dapagliflozin or its derivatives.
- Excipients: Various inactive ingredients that are combined with the active ingredient to form the final dosage form.
- Physical Characteristics: The patent specifies the physical characteristics of the formulations, such as particle size, shape, and surface area[1].
Method of Manufacture Claims
The patent also includes claims related to the methods of manufacturing these pharmaceutical formulations, including:
- Processes for Size Reduction: Techniques to reduce the particle size of the pure drug or resulting products.
- Formulation Techniques: Methods for preparing capsules or tablets, including mixing, granulating, and compressing[1].
Patent Landscape
Related Patents
The patent landscape surrounding US9198925B2 includes several other patents related to dapagliflozin, such as:
- Composition of Matter Patents: Patents like US6515117B2 and US7919598B2, which cover the molecule and crystalline forms of dapagliflozin, respectively[4].
- Method of Treatment Patents: Patents like US8791077B2 and US8883743B2, which cover specific indications and methods of treatment[4].
- Dosage Regimen Patents: Patents like US8685934B2 and US11817195B2, which cover different dosage regimens for dapagliflozin[4].
Expiration Dates
The expiration dates of these related patents vary, with some expiring as early as 2025 and others extending to 2039 and beyond. For example:
- US6515117B2: Expires on October 4, 2025.
- US7919598B2: Expires on December 16, 2029.
- US8685934B2: Expires on May 26, 2030[4].
Strategic Implications
Generic Drug Filings
The expiration of key patents, including US9198925B2, opens the door for generic drug filings. Companies like Alembic Pharmaceuticals Limited and Sun Pharmaceutical Industries Limited have already filed Abbreviated New Drug Applications (ANDAs) with paragraph IV certifications, challenging the validity or enforceability of some of these patents[2][5].
Patent Analytics
To navigate this complex patent landscape, companies often use patent analytics tools to track patents by claims and scope concepts. This helps in identifying gaps in current coverage and highlighting future design opportunities[3].
Key Takeaways
- US9198925B2 covers specific pharmaceutical formulations of dapagliflozin, including capsules and tablets.
- Expiration Date: The patent expired on October 4, 2020.
- Related Patents: Other patents cover composition of matter, methods of treatment, and dosage regimens.
- Generic Filings: Expiration of key patents allows for generic drug filings and challenges to patent validity.
- Patent Analytics: Essential for managing and analyzing the complex patent landscape surrounding dapagliflozin.
FAQs
What is the main focus of US9198925B2?
The main focus of US9198925B2 is on pharmaceutical formulations containing the SGLT2 inhibitor dapagliflozin, specifically in the form of capsules or tablets for oral use.
When did the patent expire?
The patent US9198925B2 expired on October 4, 2020.
What are some of the excipients mentioned in the patent?
The patent mentions excipients such as propylene glycol, cellulose derivatives like hydroxypropyl methylcellulose, and other inactive ingredients.
How does the expiration of this patent affect the pharmaceutical industry?
The expiration of this patent allows other companies to file for generic versions of dapagliflozin, potentially increasing competition and reducing costs for patients.
What tools are used to manage the complex patent landscape around dapagliflozin?
Companies use patent analytics tools to track patents by claims and scope concepts, helping to identify gaps in coverage and future design opportunities.
Sources
- US9198925B2 - Pharmaceutical formulations containing an SGLT2 inhibitor - Google Patents
- Dapagliflozin Tablets - FDA
- Patent Analytics - Schwegman
- Farxiga Patent Thicket - GreyB
- Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets - FDA
