Understanding the Scope and Claims of United States Patent 10,086,047
Introduction
United States Patent 10,086,047 is part of a broader portfolio of patents held by Novo Nordisk A/S, focusing on innovative pharmaceutical compositions, particularly those involving GLP-1 agonists. This patent is crucial in the context of Novo Nordisk’s flagship product, Rybelsus (semaglutide), and its generic equivalents.
Patent Overview
- Patent Number: 10,086,047
- Issuance Date: Not explicitly mentioned in the provided sources, but it is part of the series of patents related to GLP-1 agonists and their formulations.
- Assignee: Novo Nordisk A/S
- Inventors: While the specific inventors for this patent are not detailed in the sources, the broader context involves inventors such as Jesper Lau, Paw Bloch, Thomas Kruse Hansen, Per Sauerberg, Simon Bjerregaard, and Flemming Seier Nielsen, who have contributed to similar patents[2][4].
Claims and Scope
GLP-1 Agonists
The patent likely involves claims related to GLP-1 (Glucagon-Like Peptide-1) agonists, which are used in the treatment of type 2 diabetes and other metabolic disorders. GLP-1 agonists, such as semaglutide, mimic the action of the natural hormone GLP-1 to enhance glucose-dependent insulin secretion, suppress glucagon secretion, and slow gastric emptying[2].
Solid Compositions
The patent claims probably include solid compositions for oral administration, which is a significant advancement in the delivery of GLP-1 agonists. These compositions typically involve a GLP-1 agonist, a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, and various excipients such as lubricants, binders, and fillers. The specific composition ensures the stability and bioavailability of the GLP-1 agonist when administered orally[2][4].
Granule Formulations
The patent may also describe formulations involving two types of granules: one containing the GLP-1 agonist and the other containing the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid. This dual-granule approach helps in maintaining the stability and efficacy of the drug[1][5].
Patent Landscape
Related Patents
The patent 10,086,047 is part of a series of patents that cover various aspects of GLP-1 agonist formulations. Other related patents include:
- U.S. Patent No. 8,129,343: Acylated GLP-1 compounds and their therapeutic uses.
- U.S. Patent No. 8,536,122: Acylated GLP-1 compounds and their therapeutic uses.
- U.S. Patent No. 9,278,123: Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
- U.S. Patent No. 10,933,120: Pharmaceutical compositions comprising a first type of granules and a second type of granules.
- U.S. Patent No. 10,960,052: Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid[1][2][4].
Patent Expiration Dates
The expiration dates for these patents vary, but they generally fall between 2026 and 2033. For example:
- U.S. Patent No. 8,536,122: Expires on March 20, 2026.
- U.S. Patent No. 9,278,123: Expires on December 16, 2031.
- U.S. Patent No. 10,933,120: Expires on March 15, 2033[1].
Litigation and Generic Challenges
Novo Nordisk is currently involved in litigation to protect its patents against generic challenges. For instance, Apotex has filed an Abbreviated New Drug Application (ANDA) seeking approval for a generic version of Rybelsus before the expiration of the asserted patents. This litigation highlights the importance of these patents in maintaining Novo Nordisk’s market exclusivity for semaglutide[2][4].
Impact on Pharmaceutical Industry
The patents, including 10,086,047, have significant implications for the pharmaceutical industry, particularly in the development and marketing of GLP-1 agonists. These patents protect the innovative formulations and delivery methods developed by Novo Nordisk, allowing the company to maintain a competitive edge in the market.
Future Implications
As the patent landscape evolves, the expiration of these patents will open up opportunities for generic manufacturers to enter the market. However, until then, Novo Nordisk’s robust patent portfolio ensures its continued dominance in the GLP-1 agonist market.
Key Takeaways
- Patent Scope: The patent covers solid compositions for oral administration of GLP-1 agonists, including specific formulations and granule types.
- Related Patents: Part of a broader series of patents protecting various aspects of GLP-1 agonist formulations.
- Patent Expiration: Varies between 2026 and 2033.
- Litigation: Ongoing litigation to protect against generic challenges.
- Industry Impact: Significant implications for the development and marketing of GLP-1 agonists.
FAQs
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What is the main subject of U.S. Patent 10,086,047?
- The main subject is solid compositions for oral administration of GLP-1 agonists, such as semaglutide.
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Who is the assignee of this patent?
- The assignee is Novo Nordisk A/S.
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What are the key components of the solid compositions claimed in this patent?
- The compositions include a GLP-1 agonist, a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, and various excipients.
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Why is this patent important for Novo Nordisk?
- It protects the innovative formulations and delivery methods of GLP-1 agonists, maintaining Novo Nordisk’s market exclusivity.
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When do the related patents expire?
- The expiration dates vary between 2026 and 2033, depending on the specific patent.
Cited Sources:
- Generic Rybelsus Availability - Drugs.com
- Case 1:24-cv-09729-RMB-AMD Document 17 Filed 12/11/24 Page ...
- Patent Claims and Patent Scope - Hoover Institution
- Case 1:24-cv-09729-RMB Document 1 Filed 10/10/24 Page 1 of 48 ...
- (12) United States Patent - googleapis.com
