Azstarys Shortage: What Providers and Prescribers Need to Know in 2026

Updated:

February 16, 2026

Author:

Peter Daggett

Summarize this blog with AI:

A provider-focused briefing on Azstarys availability in 2026: shortage timeline, prescribing implications, alternatives, and tools to help patients.

Provider Briefing: Azstarys Availability in 2026

As a prescriber of ADHD medications, you're likely fielding calls from patients who can't fill their Azstarys prescriptions. While Azstarys (Serdexmethylphenidate/Dexmethylphenidate) is not on the FDA's official drug shortage list, real-world availability remains inconsistent — driven by the same forces affecting the broader stimulant supply chain.

This guide provides a concise overview of the current Azstarys availability landscape, prescribing considerations, cost and access issues, and practical tools you can use to help your patients maintain continuity of care.

Timeline: How We Got Here

The current stimulant availability challenges trace back to a series of events:

  • October 2022: The FDA formally acknowledged a shortage of amphetamine mixed salts (Adderall). Teva, the primary manufacturer, reported production delays.
  • 2022-2023: Patients unable to fill Adderall and generic amphetamine prescriptions began switching to methylphenidate-based alternatives, increasing demand across the entire stimulant class.
  • 2023-2024: The DEA increased aggregate production quotas for stimulant active pharmaceutical ingredients (APIs), but manufacturers cited difficulties ramping production to meet the new limits.
  • 2024-2025: While the acute Adderall shortage improved, persistent supply-demand imbalances continued across multiple stimulant products. Newer brand-name medications like Azstarys, with single-source manufacturing, were particularly vulnerable to intermittent stock-outs.
  • Early 2026: Azstarys remains off the FDA shortage list but is frequently reported as difficult to locate, especially at chain pharmacies.

Prescribing Implications

When considering Azstarys for your ADHD patients, keep these factors in mind:

Clinical Profile

Azstarys offers a distinctive pharmacokinetic profile. The combination of immediate-release Dexmethylphenidate (30% of the total d-MPH dose) with the Serdexmethylphenidate prodrug (70% of the total d-MPH dose) provides rapid onset (within 30 minutes) with sustained coverage of up to 13 hours in clinical trials.

This may benefit patients who need all-day symptom control without the peaks and troughs associated with some other extended-release formulations.

Schedule II Considerations

As a Schedule II controlled substance, Azstarys prescriptions:

  • Cannot be called in to pharmacies (must be e-prescribed or written)
  • Cannot be transferred between pharmacies
  • Are limited to a maximum of a 90-day supply in most states (though many insurers authorize only 30 days)
  • Are subject to DEA manufacturing quotas that constrain supply

Prior Authorization Burden

Most commercial payers require prior authorization for Azstarys. Many plans also impose step therapy requirements — typically requiring documented failure or intolerance of generic Methylphenidate ER or generic Amphetamine salts before approving Azstarys. Be prepared to provide clinical justification for formulary exceptions.

Current Availability Picture

Azstarys is manufactured solely by Corium (a Sun Pharmaceutical subsidiary). With no generic version available, supply depends entirely on a single production source. Key availability factors:

  • Chain pharmacies (CVS, Walgreens, Rite Aid) frequently report out-of-stock status for Azstarys
  • Independent pharmacies may have more success sourcing it through flexible wholesaler relationships
  • Specialty pharmacies focused on mental health or ADHD may maintain more consistent stock
  • Regional variation is significant — availability can differ substantially by metro area

Directing patients to check availability through Medfinder for Providers can reduce the number of fruitless pharmacy calls and improve time-to-fill.

Cost and Access

Understanding the cost landscape helps set patient expectations:

  • Cash price: $350-$571/month (30 capsules), depending on dose and pharmacy
  • Corium copay card: Reduces out-of-pocket cost to $60 or less for commercially insured patients
  • Patient assistance: Corium does not currently offer a formal patient assistance program (PAP) for uninsured patients
  • Discount cards: SingleCare and GoodRx may offer modest discounts on cash pricing

For patients without commercial insurance, the cost of Azstarys may be prohibitive. In these cases, consider generic alternatives: Dexmethylphenidate ER ($30-$80/month) or Lisdexamfetamine ($30-$100/month).

Tools and Resources for Your Practice

Medfinder for Providers

Medfinder offers a provider-facing tool that allows your team to check real-time Azstarys availability by location. This can be integrated into your prescription workflow to identify pharmacies with stock before sending the e-prescription.

Corium CoriumCares Program

Direct patients to azstarys.com/savings-and-support to enroll in the copay savings program. Your staff can also download copay cards from azstarys-pro.com/coriumcares.

Alternative Prescribing Strategies

When Azstarys is unavailable, consider:

  • Focalin XR (Dexmethylphenidate ER): Same active metabolite, generic available, typically easier to find
  • Concerta (Methylphenidate ER): Well-established, generic available, OROS delivery system
  • Vyvanse/Lisdexamfetamine: Prodrug stimulant (amphetamine-based), generic now available
  • Jornay PM: Evening-dosed methylphenidate for patients needing early-morning coverage

For detailed alternative comparisons, see our patient-facing guide on alternatives to Azstarys, which you can share with patients. For cost-saving strategies, see the provider's guide to helping patients save money on Azstarys.

Looking Ahead

Several developments may improve Azstarys accessibility in the coming months and years:

  • Generic entry: Azstarys patents became eligible for challenge in May 2025. While no generic has been approved yet, generic competition could eventually improve supply and reduce cost.
  • DEA quota adjustments: The DEA continues to evaluate and adjust aggregate production quotas for stimulant APIs in response to market demand.
  • Pipeline medications: Several new ADHD medications are in development, which may alleviate some demand pressure on existing products.

Final Thoughts

Azstarys remains a clinically valuable option for ADHD management, particularly for patients who benefit from its unique prodrug pharmacokinetics. However, the reality of limited supply, single-source manufacturing, and cost barriers means providers need proactive strategies to ensure treatment continuity.

Leveraging tools like Medfinder for Providers, maintaining familiarity with therapeutic alternatives, and helping patients navigate the cost landscape are all within your practice's reach. Your patients are counting on you to help them stay on track — even when the supply chain makes it difficult.

Is Azstarys currently in shortage according to the FDA?

No. As of early 2026, Azstarys is not listed in the FDA's drug shortage database. However, real-world availability is inconsistent, and many patients report difficulty finding it at local pharmacies due to single-source manufacturing and the broader stimulant supply challenges.

What should I prescribe if my patient can't find Azstarys?

The closest pharmacologic alternative is Dexmethylphenidate ER (generic Focalin XR), which contains the same active metabolite. Other options include Methylphenidate ER (generic Concerta) or Lisdexamfetamine (generic Vyvanse) if an amphetamine-based prodrug is appropriate. Always base the decision on the individual patient's clinical history and response.

Does Azstarys require prior authorization?

Most commercial insurance plans require prior authorization for Azstarys. Many also require step therapy — typically documented trial and failure of generic Methylphenidate ER or generic Amphetamine salts. Be prepared to submit clinical justification for formulary exceptions.

Is there a generic version of Azstarys available?

No. As of early 2026, no generic Serdexmethylphenidate/Dexmethylphenidate product has been approved. Azstarys patents became eligible for challenge in May 2025, but generic entry has not yet occurred. Until a generic is available, supply depends entirely on Corium's production.

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