Information regarding specific preparation examples for U.S. patent abrocitinib is not publicly available in detail. Patents typically describe the general methods and compositions for preparing a drug, rather than detailed, step-by-step laboratory procedures [1].
How is Abrocitinib Made?
Abrocitinib is synthesized through a multi-step chemical process. While specific proprietary details of the manufacturing process are confidential, the synthesis generally involves the creation of the core abrocitinib molecule and subsequent purification. The process aims to produce the drug substance with high purity and in a stable form suitable for formulation into the final dosage form [1].
What Are the Key Ingredients in Abrocitinib?
The active pharmaceutical ingredient is abrocitinib. The drug is formulated into tablets, which also contain inactive ingredients, known as excipients. These excipients serve various purposes, such as binding the tablet together, aiding in dissolution, and providing stability. Common excipients in tablet formulations can include fillers, binders, disintegrants, lubricants, and coating agents [2].
When Does Abrocitinib's Patent Protection End?
Patent protection for abrocitinib is a complex area that can involve multiple patents covering different aspects of the drug, including its composition, manufacturing process, and methods of use. According to DrugPatentWatch.com, patent information can be extensive and varies by region. Specific patent expiry dates can be found through specialized patent databases, which track these timelines for pharmaceutical products [3].
Who Manufactures Abrocitinib?
Abrocitinib is developed and manufactured by Pfizer Inc. [2].
Where Can I Find Abrocitinib Patent Information?
Detailed information on abrocitinib patents can be found through patent databases and resources like DrugPatentWatch.com [3]. These platforms provide data on patent filings, grant dates, expiry dates, and patent litigation, which are crucial for understanding market exclusivity and potential generic entry.
What Clinical Trials Has Abrocitinib Undergone?
Abrocitinib has undergone extensive clinical trials to evaluate its safety and efficacy in treating atopic dermatitis. Key studies, such as the JAK1 Atopic Dermatitis Exclusion trial (JADE D1) and JADE TEEN, have demonstrated the drug's ability to improve skin clearance and reduce itch in adult and adolescent patients with moderate to severe atopic dermatitis [4].
What Are the Potential Side Effects of Abrocitinib?
Common side effects associated with abrocitinib treatment include nasopharyngitis (common cold), headache, and acne. More serious potential side effects, as identified in clinical trials, can include infections, changes in certain laboratory test results (e.g., liver enzymes, creatine phosphokinase), and potential risks related to JAK inhibitors [4].
Sources
1. United States Patent Application Publication: US 2012/0220541 A1. (Publication Date: August 30, 2012)
2. Cibinqo (abrocitinib) Prescribing Information. Pfizer Inc.
3. DrugPatentWatch.com
4. ClinicalTrials.gov