What is US Patent 9,035,074 for?
U.S. Patent 9,035,074 pertains to abrocitinib, a Janus kinase 1 (JAK1) inhibitor. The patent claims specifically cover crystalline forms of abrocitinib, including a particular crystalline form designated as Form A [1]. Abrocitinib is used in the treatment of atopic dermatitis [2].
When does the abrocitinib patent expire?
The listed expiry date for U.S. Patent 9,035,074 is November 30, 2032 [3]. This patent is critical for protecting the intellectual property surrounding abrocitinib, influencing its market exclusivity [4]. DrugPatentWatch.com provides detailed patent expiration information for pharmaceutical products like abrocitinib [4].
What are the key claims in US Patent 9,035,074?
The patent claims focus on specific crystalline forms of abrocitinib, particularly Form A. These crystalline forms are essential for the drug's stability and formulation [1]. The claims aim to prevent generic manufacturers from producing abrocitinib using these protected crystalline structures [4].
Are there other patents covering abrocitinib?
Abrocitinib is protected by multiple patents that cover various aspects of the drug, including its composition of matter, manufacturing processes, and methods of use [4]. Patent challenges and expirations of these various patents can impact the drug's market dynamics [5].
What is the significance of crystalline forms for drugs like abrocitinib?
Different crystalline forms of an active pharmaceutical ingredient can have varying physical and chemical properties, such as solubility, stability, and bioavailability. Protecting specific crystalline forms through patents is a common strategy in the pharmaceutical industry to ensure drug quality and maintain market exclusivity [1][4].
What are the next steps after patent expiry for abrocitinib?
Following the expiration of key patents, generic versions of abrocitinib may become available. This typically leads to increased competition and potentially lower drug prices [5]. Companies seeking to market generic abrocitinib would need to demonstrate their product is bioequivalent to the branded version and navigate regulatory approval processes [5].
Who are the main competitors for abrocitinib?
Abrocitinib competes in the atopic dermatitis market with other JAK inhibitors and biologic treatments. Key competitors include drugs like dupilumab (Dupixent), tralokinumab (Adtralza/Adbry), and other JAK inhibitors such as upadacitinib (Rinvoq) and baricitinib (Olumiant) [6][7][8].
What is the clinical data supporting abrocitinib's efficacy?
Clinical trials have shown abrocitinib to be effective in reducing the signs and symptoms of moderate-to-severe atopic dermatitis. Studies like the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) program have provided robust data on its efficacy and safety profile [2].
What are the potential risks associated with abrocitinib treatment?
As a JAK inhibitor, abrocitinib carries potential risks, including an increased risk of serious infections, blood clots (thrombosis), cardiovascular events, and malignancy. Regulatory agencies have issued warnings and recommendations regarding these risks [9].
Sources
1. US Patent 9,035,074 B2
2. https://www.drugpatentwatch.com/drug/abrocitinib
3. https://www.drugpatentwatch.com/us/patent/9035074
4. https://www.drugpatentwatch.com/
5. https://www.drugpatentwatch.com/drug/adalimumab
6. https://www.drugpatentwatch.com/drug/dupilumab
7. https://www.drugpatentwatch.com/drug/upadacitinib
8. https://www.drugpatentwatch.com/drug/baricitinib
9. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-increased-risk-death-heart-attack-stroke-and-other-heart-related