Detailed Analysis of the Scope and Claims of United States Patent 11,241,414
Introduction to the Patent
United States Patent 11,241,414, assigned to Neurelis, Inc., is a significant intellectual property asset in the field of pharmaceuticals, particularly focusing on the administration of benzodiazepine compositions via nasal spray. This patent is crucial for the treatment of acute seizure activity in adult and pediatric patients.
Background and Context
The patent is part of Neurelis's expanding intellectual property estate, which includes several patents related to VALTOCO, a diazepam nasal spray. This specific patent, issued on October 4, 2021, is one of the key patents protecting VALTOCO, a product designed for the acute treatment of episodes of frequent seizure activity[4].
Scope of the Patent
Pharmaceutical Compositions
The patent describes pharmaceutical compositions that include one or more benzodiazepine drugs, specifically designed for nasal administration. These compositions are formulated to ensure effective delivery of the benzodiazepine through the nasal mucosa, which is a critical aspect for the rapid onset of action required in treating acute seizure episodes[1].
Key Components
The compositions outlined in the patent include:
- Benzodiazepine Drug: The primary active ingredient, such as diazepam.
- Tocopherols or Tocotrienols: Natural or synthetic forms of vitamin E, included in amounts ranging from about 30% to about 95% (w/w).
- Alcohols or Glycols: Included in amounts ranging from about 5% to about 70% (w/w), preferably about 10% to about 70% (w/w)[1].
Excipients
The patent also mentions the inclusion of additional excipients such as parabens, povidones, and alkyl glycosides, which are used to enhance the stability and delivery of the benzodiazepine drug[1].
Claims of the Patent
Method of Administration
The patent claims a method of treating a patient with a disorder that may be treatable with a benzodiazepine drug. This method involves administering the pharmaceutical composition to one or more nasal mucosal membranes of the patient. The specific formulation and the method of administration are designed to ensure rapid absorption and efficacy in treating acute seizure activity[1].
Specific Formulation Claims
The claims are detailed and specify the exact proportions of the components, ensuring that the composition meets the required standards for efficacy and safety. For example, the inclusion of tocopherols or tocotrienols and alcohols or glycols in specific weight percentages is a critical aspect of the claims[1].
Patent Landscape
Related Patents
The patent 11,241,414 is part of a broader portfolio of patents related to VALTOCO. Other relevant patents include:
- U.S. Patent No. 8,895,546: Issued earlier, this patent also covers pharmaceutical compositions comprising benzodiazepine drugs for nasal administration.
- U.S. Patent No. 11,793,786: Another patent in the same series, protecting similar aspects of the VALTOCO formulation and administration method[5].
Expiration Dates
The patent 11,241,414, along with other related patents (8,895,546 and 11,793,786), is listed in the FDA's Orange Book with an expiration date of March 27, 2029. This indicates the period during which Neurelis, Inc. will have exclusive rights to the patented compositions and methods[2][5].
Litigation and Enforcement
Neurelis, Inc. has been actively enforcing its patent rights against potential generic competitors. For instance, Neurelis has filed a complaint against Padagis LLC, Padagis US LLC, and Padagis Israel Pharmaceuticals Ltd. for alleged infringement of the '414 patent, among others. This litigation highlights the importance of these patents in protecting Neurelis's intellectual property and market position[2].
Clinical and Market Significance
The issuance of this patent, combined with a growing body of clinical data, demonstrates the safety and effectiveness of VALTOCO in treating acute seizure episodes. This is particularly significant for patient populations, including adults and pediatric patients aged six and older, who require rapid and effective treatment for seizure activity[4].
Future Implications
The protection offered by this patent ensures that Neurelis, Inc. maintains a competitive edge in the market for CNS disorder treatments. As generic versions of VALTOCO are not yet approved, Neurelis continues to benefit from the exclusivity provided by these patents until their expiration in 2029[5].
Key Takeaways
- Pharmaceutical Compositions: The patent covers specific formulations of benzodiazepine drugs for nasal administration.
- Method of Administration: The method involves administering the composition to nasal mucosal membranes.
- Key Components: Tocopherols or tocotrienols and alcohols or glycols are critical components.
- Patent Landscape: Part of a broader portfolio of patents protecting VALTOCO.
- Expiration Dates: March 27, 2029.
- Litigation: Neurelis is actively enforcing its patent rights against generic competitors.
- Clinical Significance: Demonstrates safety and effectiveness in treating acute seizure episodes.
FAQs
What is the primary active ingredient in the pharmaceutical compositions described in U.S. Patent 11,241,414?
The primary active ingredient is a benzodiazepine drug, specifically diazepam.
What is the method of administration for the compositions described in the patent?
The method involves administering the pharmaceutical composition to one or more nasal mucosal membranes of the patient.
What are the key components included in the compositions besides the benzodiazepine drug?
The key components include natural or synthetic tocopherols or tocotrienols and alcohols or glycols.
When do the patents related to VALTOCO expire?
The patents, including U.S. Patent 11,241,414, expire on March 27, 2029.
Is there a generic version of VALTOCO available in the United States?
No, there is currently no therapeutically equivalent generic version of VALTOCO available in the United States[5].
Sources
- US11241414B2 - Administration of benzodiazepine compositions - Google Patents
- 2024.05.08 Complaint - Neurelis v Padagis - Insight.RPXCorp
- Patent Analytics | Intellectual Property Law - SLWIP
- NEURELIS EXPANDS INTELLECTUAL PROPERTY ESTATE FOR VALTOCO - Neurelis
- Generic Valtoco Availability - Drugs.com
