Generic Azstarys Availability

Last updated on Apr 10, 2025.

Azstarys is a brand name of dexmethylphenidate/serdexmethylphenidate, approved by the FDA in the following formulation(s):

AZSTARYS (dexmethylphenidate hydrochloride; serdexmethylphenidate chloride - capsule;oral)

Manufacturer: COMMAVE THERAP
Approval date: May 7, 2021
Strength(s): EQ 5.2MG BASE;EQ 26.1MG BASE ^[RLD], EQ 7.8MG BASE;EQ 39.2MG BASE ^[RLD], EQ 10.4MG BASE;EQ 52.3MG BASE ^[RLD]

Is there a generic version of Azstarys available?

No. There is currently no therapeutically equivalent version of Azstarys available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Azstarys. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Methylphenidate-prodrugs, processes of making and using the same
Patent 10,584,112
Issued: March 10, 2020
Inventor(s): Mickle Travis & Guenther Sven & Chi Guochen
Assignee(s): KemPharm, Inc.
The present technology is directed to compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate. The present technology also relates to compositions and oral formulations comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof. The present technology additionally relates to a pharmaceutical kit containing the composition comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- December 9, 2037
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Methylphenidate-prodrugs, processes of making and using the same
Patent 10,584,113
Issued: March 10, 2020
Inventor(s): Mickle Travis & Guenther Sven & Chi Guochen
Assignee(s): KemPharm, Inc.
The present technology is directed to compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate. The present technology also relates to compositions and oral formulations comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof. The present technology additionally relates to a pharmaceutical kit containing the composition comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- December 9, 2037
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Methylphenidate-prodrugs, processes of making and using the same
Patent 10,759,778
Issued: September 1, 2020
Inventor(s): Mickle Travis & Guenther Sven & Chi Guochen
Assignee(s): KemPharm, Inc.
The present technology is directed to compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate. The present technology also relates to compositions and oral formulations comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof. The present technology additionally relates to a pharmaceutical kit containing the composition comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- December 9, 2037
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Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Patent 10,858,341
Issued: December 8, 2020
Inventor(s): Mickle Travis & Guenther Sven & Chi Guochen
Assignee(s): KemPharm, Inc.
The present technology is directed to compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate. The present technology also relates to compositions and oral formulations comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof. The present technology additionally relates to a pharmaceutical kit containing the composition comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- December 9, 2037
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  Patent use: TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Patent 10,954,213
Issued: March 23, 2021
Inventor(s): Mickle Travis & Guenther Sven & Chi Guochen
Assignee(s): KemPharm, Inc.
The present technology is directed to compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate. The present technology also relates to compositions and oral formulations comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof. The present technology additionally relates to a pharmaceutical kit containing the composition comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- December 9, 2037
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  Patent use: TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
Methylphenidate-oxoacid conjugates, processes of making and using the same
Patent 9,079,928
Issued: July 14, 2015
Inventor(s): Guenther Sven & Chi Guochen & Bera Bindu & Mickle Travis & Bera Sanjib
Assignee(s): KemPharm, Inc.
The present technology is directed to prodrugs and compositions for the treatment of various diseases and/or disorders comprising methylphenidate, or methylphenidate derivatives, conjugated to at least one alcohol, amine, oxoacid, thiol, or derivatives thereof. In some embodiments, the conjugates further include at least one linker. The present technology also relates to the synthesis of methylphenidate, or methylphenidate derivatives, conjugated to at least one alcohol, amine, oxoacid, thiol, or derivatives thereof or combinations thereof.
Patent expiration dates:
- July 27, 2032
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Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- May 7, 2026 - NEW CHEMICAL ENTITY

More about Azstarys (dexmethylphenidate / serdexmethylphenidate)

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* High potential for abuse 2

Approval History Drug history at FDA

User Reviews & Ratings

7.3 / 10

40 Reviews

Images

Pill KP415 429 is Azstarys dexmethylphenidate 7.8 mg / serdexmethylphenidate 39.2 mg — Azstarys dexmethylphenidate 7.8 mg / serdexmethylphenidate 39.2 mg (KP415 429)