What is US Patent 9,035,074 for?
U.S. Patent 9,035,074 covers the use of abrocitinib for treating atopic dermatitis [1]. This patent is significant for Pfizer, as abrocitinib is a selective Janus kinase 1 (JAK1) inhibitor used in the treatment of moderate-to-severe atopic dermatitis in adults and adolescents [2].
When does abrocitinib patent protection expire?
The listed expiry date for U.S. Patent 9,035,074 is November 17, 2029 [1]. However, patent expiry dates can be complex and may be subject to extensions, such as those granted under the Hatch-Waxman Act for regulatory review periods [3].
What other patents protect abrocitinib?
Beyond U.S. Patent 9,035,074, abrocitinib is protected by a portfolio of patents covering its composition of matter, manufacturing processes, and various therapeutic uses [4]. Detailed information on the full patent landscape for abrocitinib can be found on DrugPatentWatch.com [4].
How does abrocitinib work?
Abrocitinib is a selective JAK1 inhibitor. It works by blocking the activity of Janus kinase 1, an enzyme involved in the signaling pathways that contribute to inflammation and immune responses in conditions like atopic dermatitis [2]. By inhibiting JAK1, abrocitinib helps to reduce the inflammation and itching associated with the disease [2].
What are the risks associated with abrocitinib treatment?
Abrocitinib carries potential risks, including serious infections, major adverse cardiovascular events, thrombosis, and malignancy [2]. Patients taking abrocitinib are monitored for signs of these events [2].
How does abrocitinib compare to other atopic dermatitis treatments?
Abrocitinib is an oral medication, offering an alternative to topical treatments and injectable biologic therapies for atopic dermatitis [2]. It competes in a market that includes other JAK inhibitors and biologic agents that target different inflammatory pathways [5].
What is the regulatory status of abrocitinib?
Abrocitinib has received approval from regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of moderate-to-severe atopic dermatitis [2].
Can biosimilars be developed before patent expiry?
Generally, biosimilar development and approval cannot occur until the expiration of relevant patents and exclusivities. However, patent litigation and challenges can sometimes impact the timeline for biosimilar entry [3].
What is the commercial significance of abrocitinib patents?
The patents protecting abrocitinib are crucial for Pfizer's commercial interests, providing market exclusivity and allowing for the recoupment of research and development investments [4]. The expiry of these patents opens the door for potential generic or biosimilar competition.
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Sources:
[1] https://patents.google.com/patent/US9035074B2
[2] https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-cibinqo-mirikizumab-patients-12-years-age-and-older-moderate-severe-atopic-dermatitis
[3] https://drugpatentwatch.com/
[4] https://drugpatentwatch.com/drug/abrocitinib
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9893674/