United States Patent 9,345,714: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 9,345,714 is associated with the drug Ciprodex, a topical suspension formulation containing ciprofloxacin and dexamethasone. This patent is one of several that protect the intellectual property rights of Ciprodex, which is used primarily for the treatment of middle ear infections and acute otitis externa.
Patent Details
- Patent Number: US9345714
- Patent Title: Method of treating middle ear infections
- Patent Expiry: September 2022 (expired)[2].
Scope of the Patent
The patent focuses on the method of treating middle ear infections using a combination of ciprofloxacin, an antibiotic, and dexamethasone, a corticosteroid. This combination is designed to address both the bacterial infection and the associated inflammation.
Mechanism of Action
- Ciprofloxacin: Acts as an antibiotic by inhibiting bacterial DNA gyrase and topoisomerase IV, essential for bacterial DNA replication and transcription[5].
- Dexamethasone: A corticosteroid that acts as a glucocorticoid receptor agonist, reducing inflammation and swelling in the affected area[1].
Claims of the Patent
The patent claims cover the specific method of treating middle ear infections using the ciprofloxacin and dexamethasone combination. Key claims include:
- The formulation and administration method of the topical suspension.
- The therapeutic efficacy of the combination in treating middle ear infections.
- The stability and bioavailability of the formulation.
Patent Landscape
Exclusivity and Protection
The patent was part of a broader portfolio of patents protecting Ciprodex. However, as of September 2022, this particular patent has expired, along with several other related patents (US9149486, US9402805, and others)[2].
Current Status
With the expiration of this patent, the exclusivity for the specific method of treating middle ear infections using this formulation has ended. This opens the door for generic versions of Ciprodex to enter the market, provided they comply with FDA regulations.
Generic Launch Considerations
Generic manufacturers can seek FDA approval through a Paragraph IV certification, which involves asserting that the patent is invalid, unenforceable, or will not be infringed by the generic product. Several companies, including DRL and Watson, have already filed ANDAs (Abbreviated New Drug Applications) with Paragraph IV certifications for Ciprodex[5].
Regulatory Compliance
For generic versions to be approved, they must demonstrate bioequivalence and comply with FDA regulations regarding inactive ingredients, pH, and tonicity. Any changes in exception excipients (such as preservatives, buffers, or thickening agents) must be justified to ensure safety and efficacy[4].
Impact on Market Entry
The expiration of this patent, along with other related patents, significantly impacts the market entry strategy for generic versions of Ciprodex. Generic manufacturers can now more easily enter the market, provided they navigate the regulatory requirements and any ongoing legal activities related to the remaining active patents.
Ongoing Legal Activities
While the patent in question has expired, other patents related to Ciprodex, such as US8846650, remain active until June 2025. Tracking these ongoing legal activities is crucial for understanding the full scope of patent protection and identifying potential generic entry points[2].
Conclusion
The expiration of United States Patent 9,345,714 marks a significant milestone in the patent landscape for Ciprodex. As generic manufacturers prepare to enter the market, they must carefully consider the remaining patent protections, regulatory compliance, and the broader patent landscape to ensure successful market entry.
Key Takeaways
- Patent Expiration: US9345714 has expired, reducing exclusivity for Ciprodex.
- Generic Entry: Generic manufacturers can seek FDA approval via Paragraph IV certifications.
- Regulatory Compliance: Generic versions must comply with FDA regulations on bioequivalence, pH, and tonicity.
- Ongoing Patents: Other patents related to Ciprodex remain active until June 2025.
- Market Impact: Expiration opens the market for generic competition.
FAQs
What is the primary use of Ciprodex?
Ciprodex is primarily used for the treatment of middle ear infections and acute otitis externa.
What are the active ingredients in Ciprodex?
Ciprodex contains ciprofloxacin, an antibiotic, and dexamethasone, a corticosteroid.
What is the status of US Patent 9,345,714?
US Patent 9,345,714 has expired as of September 2022.
How can generic manufacturers enter the market for Ciprodex?
Generic manufacturers can enter the market by filing ANDAs with Paragraph IV certifications and complying with FDA regulations.
What are the key regulatory considerations for generic versions of Ciprodex?
Generic versions must demonstrate bioequivalence, comply with FDA regulations on inactive ingredients, pH, and tonicity, and justify any changes in exception excipients.
Sources
- DrugBank: Dexamethasone: Uses, Interactions, Mechanism of Action.
- Pharsight: Ciprodex patent expiration.
- SSRN: Patent Claims and Patent Scope.
- Regulations.gov: Alcon Pharmaceuticals, Ltd.
- Regulations.gov: September 14, 2016 - FDA.
