Is Azstarys still available?

Yes. Azstarys (NDA 212994) is listed with marketing status Prescription in the FDA Orange Book.

Does Azstarys have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Azstarys's active ingredient (Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride).

When do Azstarys's patents expire?

The FDA Orange Book lists 6 patents against Azstarys, with the last listed patent expiring Dec 09, 2037. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

Does Azstarys have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Azstarys. Exclusivity can delay generic approval independently of any listed patents.

What is Azstarys's FDA application number?

Azstarys is approved under NDA 212994, held by Commave Sub.

Orange Book product · Brand (NDA)

Azstarys

Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride

Brand (NDA)NDA 212994RLD Commave Sub

Approved

May 07, 2021

Application

Brand (NDA)

TE code

Not listed

Listed patents

Azstarys (Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride) is Commave Sub's brand-name drug, approved by the FDA under NDA 212994 in 2021. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. The FDA Orange Book lists 6 patents against it, the last expiring 2037. 1 marketing-exclusivity period is recorded.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
May 07, 2021
5 yr 3 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 07, 2026
2 mo ago
Today
Patent 9079928 expires
Listed drug product patent expiration.
May 07, 2035
in 8 yr 11 mo
Patent 10584112 expires
Listed drug substance patent expiration.
Dec 09, 2037
in 11 yr 7 mo
Patent 10584113 expires
Listed drug product patent expiration.
Dec 09, 2037
in 11 yr 7 mo
Patent 10759778 expires
Listed drug product patent expiration.
Dec 09, 2037
in 11 yr 7 mo
Patent 10858341 expires
Listed method-of-use patent (U-3094) expiration.
Dec 09, 2037
in 11 yr 7 mo
Patent 10954213 expires
Listed method-of-use patent (U-3094) expiration.
Dec 09, 2037
in 11 yr 7 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE

Strength

EQ 5.2MG BASE;EQ 26.1MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 212994

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 212994

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride family

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (1)

NCENew chemical entity exclusivity (5 years)
May 07, 2026
2 mo ago

Orange Book patent file

Listed patents

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9079928	May 07, 2035	in 8 yr 11 mo	Product
10584112	Dec 09, 2037	in 11 yr 7 mo	SubstanceProduct
10584113	Dec 09, 2037	in 11 yr 7 mo	Product
10759778	Dec 09, 2037	in 11 yr 7 mo	Product
10858341	Dec 09, 2037	in 11 yr 7 mo	U-3094
10954213	Dec 09, 2037	in 11 yr 7 mo	U-3094

Azstarys — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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