Generic competition · all medicines · read 12 November 2026
Is there a generic of Risperidone, and who makes it?
Risperidone appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 23 generic makers listed as marketed across them. 2 groups have 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 5.9 and 20.1 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.
- Risperidone appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 23 generic makers listed as marketed across them.
- 2 groups have 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 5.9 and 20.1 years after the first brand approval.
- 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.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Risperdal. 12 generic makers with 72 generic products listed as marketed; the first generic approval is dated 30 June 2008.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Rising Pharma Holdings Inc | 8 October 2008 | 6 |
| Novitium Pharma Llc | 9 October 2008 | 6 |
| Zydus Pharmaceuticals Usa Inc | 16 October 2008 | 6 |
| Dr Reddys Laboratories Ltd | 24 October 2008 | 6 |
| Torrent Pharmaceuticals Ltd | 30 October 2008 | 6 |
| Renata Plc | 29 December 2008 | 6 |
| Jubilant Cadista Pharmaceuticals Inc | 23 March 2009 | 6 |
| Sandoz Inc | 16 October 2009 | 6 |
| Chartwell Molecular Holdings Llc | 18 May 2011 | 6 |
| Ajanta Pharma Ltd | 24 August 2011 | 6 |
| Prinston Pharmaceutical Inc | 29 November 2011 | 6 |
| Ipca Laboratories Ltd | 26 June 2024 | 6 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Orally Disintegrating, Oral
Four or more generic makers listed
Every brand product here is listed as discontinued. 6 generic makers with 29 generic products listed as marketed; the first generic approval is dated 24 February 2009.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Pharmazone | 24 February 2009 | 6 |
| Ph Health Ltd | 30 April 2009 | 6 |
| Zydus Pharmaceuticals Usa Inc | 1 May 2009 | 2 |
| Sandoz Inc | 22 December 2009 | 5 |
| Sun Pharmaceutical Industries Ltd | 6 August 2010 | 5 |
| Jubilant Generics Ltd | 4 November 2011 | 5 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Powder, Intramuscular
One to three generic makers listed
Brand listed as marketed: Risperdal Consta. 3 generic makers with 11 generic products listed as marketed; the first generic approval is dated 5 December 2023.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Teva Pharmaceuticals Usa Inc | 5 December 2023 | 4 |
| Amneal Eu Ltd | 2 September 2025 | 4 |
| Nanomi Bv | 2 September 2025 | 3 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Oral
Four or more generic makers listed
Brand listed as marketed: Risperdal. 6 generic makers with 6 generic products listed as marketed; the first generic approval is dated 30 January 2009.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Ani Pharmaceuticals Inc | 30 January 2009 | 1 |
| Pharmazone | 29 July 2009 | 1 |
| Aurobindo Pharma Ltd | 4 September 2009 | 1 |
| Amneal Pharmaceuticals | 25 May 2011 | 1 |
| Tris Pharma Inc | 12 December 2012 | 1 |
| Chartwell Molecular Holdings Llc | 12 January 2015 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Suspension, Extended Release, Subcutaneous
Brand listed, no generic listed as marketed
Brand listed as marketed: Uzedy. No generic is listed as marketed.
Patents and exclusivities still listed
- 12 November 2027Patent 8221778 drug product
- 12 November 2027Patent 8741327 drug product
- 5 April 2033Patent 9023897 drug product
- 11 September 2040Patent 12128132 drug product
- 11 September 2040Patent 12383493 drug product
- 17 March 2042Patent 12329851
For Suspension, Extended Release, Intramuscular
Brand listed, no generic listed as marketed
Brand listed as marketed: Rykindo. No generic is listed as marketed.
Patents and exclusivities still listed
- 10 April 2032Patent 10406161 drug product
- 10 April 2032Patent 10098882 drug product
- 10 April 2032Patent 9532991 drug product
- 10 April 2032Patent 9446135 drug product
- 10 April 2032Patent 11110094 drug product
For Suspension, Extended Release, Subcutaneous
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
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.