Details for New Drug Application (NDA): 212994
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NDA 212994 describes AZSTARYS, which is a drug marketed by Commave Therap and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the AZSTARYS profile page.
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.
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.
Summary for 212994
| Tradename: | AZSTARYS |
| Applicant: | Commave Therap |
| Ingredient: | dexmethylphenidate hydrochloride; serdexmethylphenidate chloride |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212994
Generic Entry Date for 212994*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*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.
Pharmacology for NDA: 212994
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 212994
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZSTARYS | dexmethylphenidate hydrochloride; serdexmethylphenidate chloride | CAPSULE;ORAL | 212994 | NDA | Corium, LLC. | 65038-286 | 65038-286-99 | 100 CAPSULE in 1 BOTTLE, PLASTIC (65038-286-99) |
| AZSTARYS | dexmethylphenidate hydrochloride; serdexmethylphenidate chloride | CAPSULE;ORAL | 212994 | NDA | Corium, LLC. | 65038-429 | 65038-429-99 | 100 CAPSULE in 1 BOTTLE, PLASTIC (65038-429-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5.2MG BASE;EQ 26.1MG BASE | ||||
| Approval Date: | May 7, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 7, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,584,112 | Patent Expiration: | Dec 9, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 10,584,113 | Patent Expiration: | Dec 9, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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