Detailed Analysis of the Scope and Claims of United States Patent 10,675,325
Overview of the Patent
United States Patent 10,675,325, titled "Stable Formulations of Linaclotide," was issued on June 9, 2020, to Ironwood Pharmaceuticals, Inc. and Forest Laboratories Holdings Limited. This patent is crucial for understanding the intellectual property protection surrounding Linzess, a medication used for the treatment of gastrointestinal disorders such as constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC)[2].
Inventors and Assignees
The patent was invented by Mo Yun, Fretzen Angelika, Cali Brian, and Dedhiya Mahendra. The assignees are Ironwood Pharmaceuticals, Inc. and Forest Laboratories Holdings Limited, indicating a collaborative effort in the development of the formulations[2].
Scope of the Patent
Claims
The patent primarily focuses on stable pharmaceutical compositions comprising linaclotide or its pharmaceutically acceptable salts. Here are some key aspects of the claims:
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Stable Formulations: The patent describes various methods and processes for the preparation and use of stable pharmaceutical compositions of linaclotide. These formulations are designed to maintain the stability and efficacy of linaclotide, which is a GC-C receptor agonist[2][4].
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Pharmaceutical Compositions: The claims include detailed descriptions of the pharmaceutical compositions, including the active ingredient (linaclotide), excipients, and the methods of preparing these formulations. This ensures that the final product remains stable and effective for oral administration[2].
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Methods of Preparation: The patent outlines specific methods for preparing these stable formulations, including the use of particular excipients and manufacturing processes. This is critical for ensuring the consistency and quality of the final product[4].
Technological Classification
The patent is classified under several categories within the Cooperative Patent Classification (CPC) system, including:
- A61K 38/12: Pharmaceutical compositions containing peptides or proteins
- A61K 9/1611: Oral forms
- A61K 9/1641: Tablets
- A61K 9/1676: Coated tablets
- A61K 38/10: Peptides or proteins
- A61K 47/18: Specific excipients[4].
Patent Expiration Date
The patent is set to expire on August 11, 2031. This date is significant because it marks the end of the exclusive rights granted to the patent holders, after which generic versions of the drug could potentially be developed and marketed, assuming no other exclusivities or patent extensions are in place[2].
Legal Activities and Maintenance
To maintain the validity of the patent, the holders have been actively engaged in legal activities such as the payment of maintenance fees. For example, a payment of the 4th year maintenance fee for a large entity was made on November 22, 2023, for this patent[1].
Impact on Generic Launch
The expiration of this patent, along with other related patents and exclusivities, will play a crucial role in determining when generic versions of Linzess can be launched. Currently, there are no therapeutically equivalent generic versions of Linzess available in the United States due to the active patents and exclusivities[2].
FDA Exclusivities
In addition to the patent protection, Linzess has been granted several exclusivities by the FDA, which further delay the launch of generic versions. These exclusivities can run concurrently with the patent protection and are a critical factor in the market exclusivity of the drug[1].
Conclusion on Patent Landscape
The patent landscape for Linzess, particularly around the stable formulations of linaclotide, is complex and involves multiple patents with varying expiration dates. Understanding these patents and their claims is essential for pharmaceutical companies, researchers, and regulatory bodies to navigate the intellectual property landscape and plan for future developments in gastrointestinal treatments.
Key Takeaways
- Stable Formulations: The patent focuses on stable pharmaceutical compositions of linaclotide.
- Expiration Date: The patent expires on August 11, 2031.
- Legal Activities: Regular maintenance fees are paid to keep the patent active.
- Impact on Generics: The patent's expiration will influence when generic versions of Linzess can be launched.
- FDA Exclusivities: Additional FDA-granted exclusivities delay the generic launch.
Frequently Asked Questions (FAQs)
Q1: What is the main focus of United States Patent 10,675,325?
A1: The main focus is on stable pharmaceutical compositions comprising linaclotide or its pharmaceutically acceptable salts for treating gastrointestinal disorders.
Q2: Who are the inventors and assignees of this patent?
A2: The inventors are Mo Yun, Fretzen Angelika, Cali Brian, and Dedhiya Mahendra. The assignees are Ironwood Pharmaceuticals, Inc. and Forest Laboratories Holdings Limited.
Q3: When is the patent set to expire?
A3: The patent is set to expire on August 11, 2031.
Q4: What role do FDA exclusivities play in the market exclusivity of Linzess?
A4: FDA exclusivities granted to Linzess delay the launch of generic versions, running concurrently with the patent protection.
Q5: Are there any generic versions of Linzess available currently?
A5: No, there are currently no therapeutically equivalent generic versions of Linzess available in the United States.
Cited Sources
- Pharsight - GreyB: Linzess patent expiration.
- Drugs.com: Generic Linzess Availability.
- CiteSeerX: Patent portfolio analysis.
- Google Patents: United States Patent 10,675,325.
