Detailed Analysis of the Scope and Claims of United States Patent 10,532,036
Introduction
United States Patent 10,532,036, issued on January 14, 2020, pertains to a combination pharmaceutical composition designed for the treatment of pain. This patent, assigned to AFT Pharmaceuticals Limited, is a significant development in the field of pain management, combining two widely used analgesics: ibuprofen and paracetamol (also known as acetaminophen).
Inventors and Assignees
The patent was invented by Atkinson Hartley Campbell and assigned to AFT Pharmaceuticals Limited, a company known for its innovative pharmaceutical products[5].
Patent Scope
The patent covers a specific combination of ibuprofen and paracetamol, designed to provide effective pain relief while minimizing the risks associated with higher doses of individual analgesics.
Active Ingredients
- The composition includes about 125 mg to about 150 mg of ibuprofen.
- It also includes about 475 mg to about 500 mg of paracetamol[1][2][5].
Claims
The patent claims are centered around the specific formulation and the therapeutic benefits it offers.
Therapeutic Doses
- The claimed doses are within the therapeutic range for both ibuprofen and paracetamol. A full therapeutic dose of ibuprofen is typically 400 mg, and for paracetamol, it is 1000 mg. The combination ensures that the total daily amount does not exceed the recommended limits (4000 mg for paracetamol and 1200 mg for ibuprofen per day in divided doses)[1].
Synergetic Effect
The combination of ibuprofen and paracetamol is known to have a synergetic effect, meaning the combined effect is greater than the sum of their individual effects. This is particularly beneficial in managing pain effectively without increasing the risk of adverse effects associated with higher doses of single analgesics[4].
Formulation
The patent describes the composition in various forms, including tablets and capsules. The formulation ensures that the active ingredients are delivered in a controlled manner, enhancing bioavailability and efficacy[2][4].
Patent Landscape
The patent landscape surrounding this invention is complex and involves several related patents and exclusivities.
Related Patents
- Patent 11,197,830: This patent, issued on December 14, 2021, describes solid oral dosage forms containing different ratios of acetaminophen and ibuprofen. It includes formulations with 325 mg of acetaminophen and 97.5 mg of ibuprofen, or 500 mg of acetaminophen and 150 mg of ibuprofen[5].
- Patent 11,534,407: Although the details are not extensively provided, this patent also pertains to similar combinations of analgesics and is set to expire on February 27, 2039[5].
Exclusivities
The patent holder enjoys exclusivity granted by the FDA, which can run concurrently with the patent. For this particular patent, the exclusivity period is set to expire on March 1, 2026[5].
Patent Expiration
The patent is set to expire on September 22, 2025. This expiration date is crucial as it marks the end of the exclusive rights granted to the patent holder, allowing other manufacturers to produce generic versions of the combination composition[5].
Manufacturing Process
The patent also describes the manufacturing process, including the use of binding agents, modified starch, and other excipients to ensure the stability and efficacy of the formulation. The process involves combining the active ingredients with these excipients to form tablets or capsules[2].
Clinical Significance
The combination of ibuprofen and paracetamol is clinically significant because it addresses the need for effective pain management while minimizing the risk of adverse effects. This combination is particularly useful for treating acute pain, where the rapid onset of action and synergistic effects can provide quick and sustained relief[1][2].
Examples of Combinations
Other known combinations include paracetamol, ibuprofen, and codeine in South Africa, and paracetamol, aspirin, and codeine in other regions. These combinations highlight the versatility and effectiveness of combining different analgesics to achieve better pain management outcomes[1].
Regulatory Considerations
The patent and its related exclusivities are subject to regulatory oversight by the FDA. The FDA grants exclusivity based on statutory requirements, which can include new chemical entities, new uses for existing drugs, or other significant innovations[5].
Conclusion
United States Patent 10,532,036 represents a significant advancement in pain management by combining ibuprofen and paracetamol in a specific formulation. The patent's scope and claims are well-defined, ensuring a synergistic therapeutic effect while adhering to safe dosage limits. As the patent landscape evolves, understanding the expiration dates, related patents, and exclusivities is crucial for both the patent holders and potential generic manufacturers.
Key Takeaways
- The patent covers a combination of 125-150 mg ibuprofen and 475-500 mg paracetamol.
- The formulation is designed to provide a synergistic effect for pain relief.
- The patent is set to expire on September 22, 2025.
- Related patents include different ratios of acetaminophen and ibuprofen.
- FDA exclusivity is granted until March 1, 2026.
- The manufacturing process involves specific excipients and binding agents.
FAQs
What are the active ingredients in the patented composition?
The active ingredients are ibuprofen (125-150 mg) and paracetamol (475-500 mg)[1][2][5].
What is the therapeutic significance of this combination?
The combination provides a synergistic effect, enhancing pain relief while minimizing the risk of adverse effects associated with higher doses of single analgesics[1][4].
When does the patent expire?
The patent is set to expire on September 22, 2025[5].
Are there related patents?
Yes, there are related patents such as Patent 11,197,830 and Patent 11,534,407, which describe different combinations and formulations of analgesics[5].
What is the FDA exclusivity period for this patent?
The FDA exclusivity period is set to expire on March 1, 2026[5].
Cited Sources
- US10532036B2 - Combination composition - Google Patents
- US11918693B2 - Ibuprofen and acetaminophen tablet - Google Patents
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- EP1781277B1 - A combination composition comprising ibuprofen and paracetamol - Google Patents
- Generic Combogesic Availability - Drugs.com
