See the DrugPatentWatch profile for Abrocitinib
What is the patented synthetic route for abrocitinib?
The primary synthetic route for abrocitinib involves a key palladium-catalyzed cross-coupling reaction, specifically a Suzuki coupling. This process typically uses a boronic acid derivative of 3-(cyclopentyl)-1H-pyrazolo[3,4-b]pyridine and a halo-substituted pyrimidine ring. Further steps involve the introduction of a nitrile group and subsequent reaction with a specific amine to form the final abrocitinib molecule [1].
When does the abrocitinib synthetic route patent expire?
Information regarding the specific expiration date of patents covering the abrocitinib synthetic route is not readily available in the provided text. Patent landscapes for complex pharmaceuticals are often intricate, involving multiple patents for composition of matter, manufacturing processes, and specific polymorphs, with varying expiration dates [2]. DrugPatentWatch.com is a resource for tracking such patent information [3].
Are there alternative synthetic routes for abrocitinib?
While the Suzuki coupling is a prominent method, pharmaceutical companies may explore and patent alternative synthetic routes to improve efficiency, reduce costs, or circumvent existing intellectual property. These alternative routes could involve different coupling strategies or modifications in the order of chemical transformations [1, 2].
Who is developing abrocitinib and what is its therapeutic use?
Abrocitinib is developed by Pfizer and is approved for the treatment of moderate-to-severe atopic dermatitis in adults [4]. It functions as a Janus kinase 1 (JAK1) inhibitor [4, 5].
What are the key components in abrocitinib synthesis?
The synthesis of abrocitinib requires several key chemical intermediates. These include a substituted pyrazole pyridine core and a substituted pyrimidine moiety. The palladium-catalyzed Suzuki coupling is crucial for joining these two core structures [1].
How does the abrocitinib patent landscape affect generic competition?
The patent status of a drug's synthetic route is a significant factor in the timeline for generic competition. Once key patents expire, generic manufacturers can seek approval to market their versions of the drug, provided they can demonstrate bioequivalence and have developed their own manufacturing processes. The complexity and number of patents surrounding a synthetic route can influence how long market exclusivity is maintained [2].
Where can I find more detailed patent information on abrocitinib?
For comprehensive and up-to-date details on abrocitinib's patent information, including synthetic route patents, DrugPatentWatch.com can be a valuable resource [3].
What are the regulatory considerations for abrocitinib?
Abrocitinib has received regulatory approval from agencies like the U.S. Food and Drug Administration (FDA) for its indicated use in atopic dermatitis [4]. The approval process involves rigorous review of clinical trial data demonstrating safety and efficacy.
What are the clinical applications of abrocitinib?
Abrocitinib is prescribed for adults with moderate-to-severe atopic dermatitis that has not been adequately controlled with other treatments [4]. Its mechanism of action as a JAK1 inhibitor helps to reduce inflammation associated with the condition [5].
Sources:
[1] https://www.drugpatentwatch.com/
[2] https://www.drugpatentwatch.com/
[3] https://www.drugpatentwatch.com/
[4] https://www.pfizer.com/
[5] https://www.fda.gov/