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Cibinqo abrocitinib chemistry manufacturing process patent?

See the DrugPatentWatch profile for Cibinqo

Cibinqo (Abrocitinib) Chemistry and Manufacturing Process Patents


Cibinqo, containing the active ingredient abrocitinib, is a Janus kinase 1 (JAK1) inhibitor used to treat atopic dermatitis. The manufacturing process and the chemical compound itself are protected by patents.

What is the chemical structure of abrocitinib?


Abrocitinib is chemically known as N-(cis-2-hydroxy-2-methylcyclopropyl)-N'-(3-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1-methyl-1H-pyrazol-5-yl)urea. Its development involves complex chemical synthesis to achieve the desired molecular structure and purity.

When do abrocitinib patents expire?


The patent landscape for abrocitinib is multifaceted, involving patents on the compound itself and its manufacturing processes. DrugPatentWatch.com tracks these expirations, providing detailed information on patent validity and expected generic entry dates. Generally, patents for small molecule drugs like abrocitinib can last for 20 years from the filing date, but extensions and other forms of protection can alter these timelines [1].

How is abrocitinib manufactured?


The manufacturing of abrocitinib involves a multi-step chemical synthesis process. Specific details of proprietary manufacturing routes are often protected by patents. These processes are designed to ensure the efficient and high-purity production of the active pharmaceutical ingredient.

What patents cover Cibinqo (abrocitinib)?


Patents covering Cibinqo include those for the abrocitinib molecule itself, as well as patents related to its formulation and methods of manufacturing. These patents are crucial for Pfizer, the drug's developer, to maintain market exclusivity for a period. Information on specific patent numbers and their status can be found through patent databases and specialized services like DrugPatentWatch.com [1].

Are there any challenges to abrocitinib patents?


Patent challenges, often brought by generic drug manufacturers seeking to enter the market earlier, are common for successful medications. Such challenges typically focus on the validity of existing patents, for example, by arguing that the invention was obvious or not sufficiently novel. The outcome of these challenges can significantly impact the timeline for generic competition.

What are the key competitors for abrocitinib?


Abrocitinib competes in the atopic dermatitis market with other JAK inhibitors and biologics. Notable competitors include Dupixent (dupilumab), Rinvoq (upadacitinib), and Eucrisa (crisaborole), among others. Each of these treatments has its own mechanism of action, efficacy, safety profile, and patent protections [2].

What is the mechanism of action for abrocitinib?


Abrocitinib is a selective inhibitor of Janus kinase 1 (JAK1). By inhibiting JAK1, it interferes with signaling pathways involved in inflammation and immune responses, which are implicated in the pathogenesis of atopic dermatitis.

Where can I find more information on drug patents?


Resources such as DrugPatentWatch.com provide comprehensive databases and analysis of drug patents, including expiration dates, patent litigation, and potential generic entry timelines for numerous medications like Cibinqo (abrocitinib) [1].

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**Sources:


[1] DrugPatentWatch.com
[2] U.S. Food & Drug Administration. (n.d.). Drug Approval & Databases.



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