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Azstarys is a drug marketed by Commave Therap and is included in one NDA. There are six patents protecting this drug.
This drug has sixty-four patent family members in twenty-eight countries.
The generic ingredient in AZSTARYS is dexmethylphenidate hydrochloride; serdexmethylphenidate chloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride; serdexmethylphenidate chloride profile page.
Azstarys will be eligible for patent challenges on May 7, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 9, 2037. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
DrugPatentWatch® Estimated Generic Entry Opportunity Date for AZSTARYS
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.