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OmniRx › Tools › Generic competition check › Lisdexamfetamine Dimesylate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Lisdexamfetamine Dimesylate, and who makes it?

Lisdexamfetamine Dimesylate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 18 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 6.6 and 16.5 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Lisdexamfetamine Dimesylate3 dosage-form groups in the Orange Book
18generic makers listed
  1. Lisdexamfetamine Dimesylate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 18 generic makers listed as marketed across them.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Where both are dated, the first generic approval came between 6.6 and 16.5 years after the first brand approval.
  4. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Capsule, Oral

Four or more generic makers listed

Brand listed as marketed: Vyvanse. 16 generic makers with 111 generic products listed as marketed; the first generic approval is dated 25 August 2023.

200520102015202020252030016brand 2007Actavis Elizabeth Llc, first approval 25 August 2023Alkem Laboratories Ltd, first approval 25 August 2023Amneal Pharmaceuticals Llc, first approval 25 August 2023Apotex Inc, first approval 25 August 2023Ascent Pharmaceuticals Inc, first approval 25 August 2023Hikma Pharmaceuticals Usa Inc, first approval 25 August 2023Lannett Co Inc, first approval 25 August 2023Mylan Pharmaceuticals Inc, first approval 25 August 2023Norwich Pharmaceuticals Inc, first approval 25 August 2023Prinston Pharmaceutical Inc, first approval 25 August 2023Rhodes Pharmaceuticals Lp, first approval 25 August 2023Specgx Llc, first approval 25 August 2023Sun Pharmaceutical Industries Inc, first approval 25 August 2023Sandoz Inc, first approval 26 July 2024Elite Laboratories Inc, first approval 15 November 2024Granules Pharmaceuticals Inc, first approval 29 January 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Actavis Elizabeth Llc25 August 20237
Alkem Laboratories Ltd25 August 20237
Amneal Pharmaceuticals Llc25 August 20236
Apotex Inc25 August 20237
Ascent Pharmaceuticals Inc25 August 20237
Hikma Pharmaceuticals Usa Inc25 August 20237
Lannett Co Inc25 August 20237
Mylan Pharmaceuticals Inc25 August 20237
Norwich Pharmaceuticals Inc25 August 20237
Prinston Pharmaceutical Inc25 August 20237
Rhodes Pharmaceuticals Lp25 August 20237
Specgx Llc25 August 20237

4 more makers are listed in the data.

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Tablet, Chewable, Oral

Four or more generic makers listed

Brand listed as marketed: Vyvanse. 6 generic makers with 36 generic products listed as marketed; the first generic approval is dated 25 August 2023.

201520202025203006brand 2017Ascent Pharmaceuticals Inc, first approval 25 August 2023Sun Pharmaceutical Industries Inc, first approval 25 August 2023Teva Pharmaceuticals Development Inc, first approval 25 August 2023Msn Laboratories Private Ltd, first approval 2 February 2024Granules Pharmaceuticals Inc, first approval 16 December 2024Specgx Llc, first approval 17 December 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Ascent Pharmaceuticals Inc25 August 20236
Sun Pharmaceutical Industries Inc25 August 20236
Teva Pharmaceuticals Development Inc25 August 20236
Msn Laboratories Private Ltd2 February 20246
Granules Pharmaceuticals Inc16 December 20246
Specgx Llc17 December 20246

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Arynta. No generic is listed as marketed.

2020202520302035204001brand 2025data datePatent 12433859 listed to expire 16 April 2040Patent 12582620 listed to expire 16 April 2040Patent 11576878 listed to expire 30 August 2040
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 16 April 2040Patent 12433859 drug product
  • 16 April 2040Patent 12582620 drug product
  • 30 August 2040Patent 11576878 drug product

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.