See the DrugPatentWatch profile for Quetiapine
Quetiapine fumarate, the active ingredient in Seroquel, has faced significant patent challenges and expirations, allowing for the introduction of generic versions.
When did key patents for Quetiapine fumarate expire?
The primary patents protecting Quetiapine fumarate, specifically those covering the drug substance and its use, have expired. For instance, U.S. Patent No. 4,877,870, which covered quetiapine and its use for treating schizophrenia and bipolar disorder, expired in 2007 [1]. Other related patents have also expired or been invalidated, paving the way for generic competition.
Who manufactures generic Quetiapine fumarate?
Numerous pharmaceutical companies manufacture generic versions of quetiapine fumarate. These include major generic drug producers and smaller specialized firms. Companies that have marketed generic quetiapine fumarate include Teva Pharmaceuticals, Mylan, and Dr. Reddy's Laboratories, among others [2].
What is the patent status of extended-release Quetiapine fumarate?
Extended-release formulations of quetiapine fumarate, such as those marketed as Seroquel XR, also had patent protection. However, these patents have also faced legal challenges and have largely expired or been overcome by generic manufacturers. For example, patent litigation has occurred around these extended-release formulations [3].
How did patent litigation impact Quetiapine fumarate availability?
Patent litigation has been a significant factor in the market entry of generic quetiapine fumarate. Companies seeking to market generics often challenge existing patents, leading to court battles. These legal proceedings can determine when generic versions become available and under what conditions [3].
What are the regulatory considerations for generic Quetiapine fumarate?
For generic quetiapine fumarate to be approved by regulatory agencies like the U.S. Food and Drug Administration (FDA), manufacturers must demonstrate that their product is bioequivalent to the brand-name drug (Seroquel) [4]. This ensures that the generic version delivers the same amount of active ingredient into the bloodstream over the same period.
Where can I find more information on Quetiapine fumarate patents?
Detailed information regarding patents for quetiapine fumarate, including expiration dates, legal challenges, and relevant patent numbers, can be found on specialized patent databases. DrugPatentWatch.com is a resource that tracks drug patents and their status [1][2][3].