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Vyvanse Legal and Patent Challenges: FDA History, Litigation, and Generic Entry

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At a glance

  • First FDA approval / February 23, 2007 (NDA 021977, new molecular entity) [2]
  • Chewable tablet approval / January 28, 2017 (NDA 208510) [3]
  • Efficacy supplement for a new indication / Action date January 30, 2015 [2]
  • First generic approvals / August 25, 2023 (FDA approval date, not launch date) [2][4]
  • Oral solution / Arynta 10 mg/mL, approved June 16, 2025 (NDA 219847) [4]
  • Application holder listed by FDA / Takeda Pharmaceuticals USA [2]
  • Controlled substance schedule / Schedule II [1]
  • Sport / Named in WADA S6.A, prohibited in-competition [5]

When did the FDA approve Vyvanse?

FDA approved Vyvanse capsules on February 23, 2007 under NDA 021977, classified as a type 1 new molecular entity [2]. The application is listed under Takeda Pharmaceuticals USA [2]. The approved capsules come in 10, 20, 30, 40, 50, 60 and 70 mg strengths, are prescription only, and lisdexamfetamine is a Schedule II controlled substance [1][2].

A chewable tablet followed: NDA 208510, original approval January 28, 2017, in strengths from 10 mg to 60 mg [3]. A third form, the oral solution Arynta (lisdexamfetamine dimesylate 10 mg/mL, Azurity), was approved on June 16, 2025 under NDA 219847 [4].

What does Vyvanse treat, and when did that change?

The current label lists two indications: ADHD in adults and children 6 years and older, and moderate to severe binge eating disorder in adults [1]. It is not recommended in children younger than 6, and it is not indicated for weight loss [1]. The label in effect is dated April 30, 2026 [1].

FDA's supplement record for NDA 021977 shows an efficacy supplement for a new indication with an action date of January 30, 2015 [2]. The current label lists binge eating disorder in adults [1]; the text of that 2015 supplement was not checked here.

When did generic lisdexamfetamine become available?

Generic lisdexamfetamine capsules and chewable tablets were first approved on August 25, 2023, under many ANDAs, for example Actavis, Hikma, Amneal, Mylan, Sun, Norwich, Rhodes, Teva and Ascent. Later approvals include Sandoz on July 26, 2024 and Granules on January 29, 2025 [2][4]. These are FDA approval dates, not launch dates.

What about the patent litigation?

The FDA approval records used for this page do not contain patent numbers, court decisions, settlement terms or filing dates for any lisdexamfetamine patent challenge, so none are described here. Litigation history would have to come from separate patent and court records.

FDA also publishes the Orange Book, which lists approved drug products together with patent and exclusivity information and sets out a formal process for disputing the accuracy or relevance of a patent listing [6].

Other legal limits that apply

Two restrictions sit alongside the approval history. Lisdexamfetamine is a Schedule II controlled substance, and the Vyvanse label carries a boxed warning for abuse, misuse and addiction, which can lead to a substance use disorder and, with misuse or abuse, to overdose and death [1].

In sport, WADA names lisdexamfetamine in class S6.A (non-specified stimulants), prohibited in-competition, and the 2027 List keeps it there [5][7]. In WADA-governed competition a prescription requires a Therapeutic Use Exemption [5].

Frequently asked questions

When was Vyvanse first approved by the FDA?
February 23, 2007, as NDA 021977 for lisdexamfetamine dimesylate capsules, classified as a new molecular entity [2]. Chewable tablets were approved later, on January 28, 2017, under NDA 208510 [3].
When did generic lisdexamfetamine come out?
Generic lisdexamfetamine capsules and chewable tablets were first approved on August 25, 2023, under multiple ANDAs. Later approvals include Sandoz on July 26, 2024 and Granules on January 29, 2025 [2][4]. These are approval dates, not launch dates.
Is lisdexamfetamine a controlled substance?
Yes. The Vyvanse label states that lisdexamfetamine is a prodrug of amphetamine and a Schedule II controlled substance [1].
When was Vyvanse approved for binge eating disorder?
The FDA supplement record for NDA 021977 shows an efficacy supplement for a new indication with an action date of January 30, 2015 [2], and the current label lists moderate to severe binge eating disorder in adults [1]. The supplement text itself was not checked.
What forms of lisdexamfetamine are FDA-approved?
Capsules from 10 mg to 70 mg under NDA 021977 [2], chewable tablets from 10 mg to 60 mg under NDA 208510, first approved in 2017 [3], and Arynta oral solution 10 mg/mL under NDA 219847, approved June 16, 2025 [4].

References

  1. U.S. National Library of Medicine, DailyMed. Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets, Takeda prescribing information. Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets, Takeda label
  2. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  3. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  4. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  5. World Anti-Doping Agency. World Anti-Doping Agency
  6. Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book | FDA. Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book | FDA
  7. World Anti-Doping Agency. World Anti-Doping Agency
Evidence overview for Vyvanse Legal and Patent Challenges: FDA History, Litigation, and Generic Entry