Generics for sale

About lisdexamfetamine

Lisdexamfetamine manufacturers include the originator Takeda (Vyvanse, Elvanse), around 15 US generic companies approved since August 2023, and EU generic producers active since October 2024. Lisdexamfetamine dimesylate is a prodrug of dextroamphetamine, a central nervous system stimulant used for ADHD and, in the US, binge eating disorder. Pharmaceutical companies can source lisdexamfetamine capsules, chewable tablets and oral solution through out-licensing, supply or technology transfer. Dossiers are available in EU CTD and US ANDA formats.

Lisdexamfetamine key facts

Lisdexamfetamine manufacturers and licensing history

Lisdexamfetamine was developed by New River Pharmaceuticals of Virginia, which co-developed it with Shire. Shire acquired New River in 2007 for about $2.6 billion, shortly after the first FDA approval. Takeda took over the product when it acquired Shire in January 2019.

Takeda sells lisdexamfetamine as Vyvanse in the US and as Elvanse in Europe. Shionogi holds Japanese rights to Vyvanse. In the US, about 15 generic companies received approval in August 2023 (Managed Healthcare Executive). In Germany, Stada, Aliud, ratiopharm and Aristo launched generics from October 2024 (Apotheke Adhoc).

Lisdexamfetamine API suppliers are concentrated in India, the US and Europe. Because the API is a controlled substance, producers need national narcotics or DEA licences in addition to GMP certification. Buyers should confirm a US DMF or EU ASMF, and the supplier’s export permit history, before choosing a dossier partner.

Lisdexamfetamine dosage forms and dossier types

Lisdexamfetamine is approved as hard capsules, chewable tablets and, in Germany, a generic oral solution. Generic lisdexamfetamine manufacturers most often develop capsules, because capsules are the reference form in both the US and the EU.

Lisdexamfetamine regulatory and patent status

The FDA approved Vyvanse capsules under NDA 021977 on 23 February 2007, for ADHD in children aged 6–12. Adult ADHD followed in 2008, binge eating disorder in January 2015 and chewable tablets in January 2017. US generic lisdexamfetamine capsules and chewables were approved in August 2023.

In Europe, Elvanse was authorised through decentralised procedures led by the UK MHRA. The paediatric procedure closed positively on 18 December 2012 across eight countries (Shire release). The adult procedure closed in January 2015 (Takeda).

EU market access differs by country for lisdexamfetamine manufacturers. The German Federal Patent Court declared the national SPC invalid (3 Ni 22/22 (EP)), and that ruling is under appeal. A Swedish court dismissed Stada’s SPC challenge on 21 January 2025 (Kluwer Patent Blog). The UK High Court upheld Takeda’s SPC in September 2026 (MLex). Confirm national SPC expiry dates in each patent register before launch.

Lisdexamfetamine mechanism of action and therapeutic use

Lisdexamfetamine is pharmacologically inactive until enzymes in red blood cells cleave it into L-lysine and dextroamphetamine. Dextroamphetamine blocks reuptake and increases release of noradrenaline and dopamine. The prodrug design gives a gradual onset and long duration. Approved uses are ADHD from age 6 and, in the US, moderate to severe binge eating disorder in adults.

Lisdexamfetamine licensing and sourcing

Lisdexamfetamine suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, US FDA or WHO GMP), dossier format and readiness, controlled-substance licences and territory availability. Current offers and supplier contacts are listed among the lisdexamfetamine manufacturers on Pipelinepharma.

Frequently asked questions about lisdexamfetamine

Who are the main lisdexamfetamine manufacturers?

Lisdexamfetamine was developed by New River Pharmaceuticals and is now owned by Takeda, which sells Vyvanse and Elvanse. Since August 2023, about 15 generic companies hold US approvals for capsules or chewable tablets. In Germany, Stada, Aliud, ratiopharm and Aristo have marketed generics since October 2024.

Which countries produce lisdexamfetamine API and finished dosage forms?

Lisdexamfetamine API and finished products come mainly from India, the United States and the European Union. Indian and US producers supply most US ANDA products. Buyers should ask API suppliers for a US DMF or EU ASMF and for controlled-substance manufacturing licences.

Is a lisdexamfetamine EU CTD dossier available for licensing?

Yes. Lisdexamfetamine capsule dossiers in EU CTD format are offered for out-licensing, with strengths of 20 mg to 70 mg referencing Elvanse. Oral solution dossiers are also emerging. Buyers should check SPC status in each target country before filing, because protection differs between EU states.

Is there a generic version of lisdexamfetamine?

Yes. The US FDA approved the first generic lisdexamfetamine capsules and chewable tablets in August 2023. In the EU, generics launched in Germany in October 2024 after the national SPC was declared invalid. In Sweden and the UK, courts upheld Takeda’s SPC in 2025 and 2026.

What forms and strengths of lisdexamfetamine are available?

Lisdexamfetamine capsules are approved in the US in 10, 20, 30, 40, 50, 60 and 70 mg. US chewable tablets come in 10 mg to 60 mg. EU Elvanse capsules come in 20 mg to 70 mg, and a generic oral solution is marketed in Germany.

Is lisdexamfetamine a controlled substance?

Yes. Lisdexamfetamine is a Schedule II controlled substance in the US and a controlled drug in the UK and Germany. Manufacturers need controlled-substance licences, and US producers need DEA registration and production quota. Cross-border supply requires import and export permits in both countries.