Generic competition · all medicines · read 12 November 2026
Is there a generic of Mycophenolate Mofetil, and who makes it?
Mycophenolate Mofetil appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 16 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 11.1 and 16.1 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.
- Mycophenolate Mofetil appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 16 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 11.1 and 16.1 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.
Capsule, Oral
Four or more generic makers listed
Brand listed as marketed: Cellcept. 10 generic makers with 10 generic products listed as marketed; the first generic approval is dated 29 July 2008.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Sandoz Inc | 15 October 2008 | 1 |
| Accord Healthcare Inc | 4 May 2009 | 1 |
| Teva Pharmaceuticals Usa | 6 May 2009 | 1 |
| Strides Pharma Global Pte Ltd | 10 June 2010 | 1 |
| Alkem Laboratories Ltd | 13 June 2013 | 1 |
| Zhejiang Hisun Pharmaceutical Co Ltd | 13 November 2017 | 1 |
| Concord Biotech Ltd | 8 January 2019 | 1 |
| Aurobindo Pharma Ltd | 5 January 2024 | 1 |
| Hetero Labs Ltd Unit V | 22 October 2024 | 1 |
| Wuxi Fortune Pharmaceutical Co Ltd | 7 November 2024 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Cellcept. 8 generic makers with 8 generic products listed as marketed; the first generic approval is dated 29 July 2008.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Sandoz Inc | 15 October 2008 | 1 |
| Accord Healthcare Inc | 4 May 2009 | 1 |
| Strides Pharma Global Pte Ltd | 10 June 2010 | 1 |
| Alkem Laboratories Ltd | 4 November 2011 | 1 |
| Zhejiang Hisun Pharmaceutical Co Ltd | 16 November 2017 | 1 |
| Concord Biotech Ltd | 31 July 2020 | 1 |
| Aurobindo Pharma Ltd | 20 February 2024 | 1 |
| Hetero Labs Ltd Unit V | 22 October 2024 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
For Suspension, Oral
Four or more generic makers listed
Brand listed as marketed: Cellcept. 8 generic makers with 8 generic products listed as marketed; the first generic approval is dated 14 November 2014.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Alkem Laboratories Ltd | 14 November 2014 | 1 |
| Vistapharm Llc | 12 February 2019 | 1 |
| Quagen Pharmaceuticals Llc | 29 July 2021 | 1 |
| Amneal Pharmaceuticals Llc | 2 November 2021 | 1 |
| Strides Pharma International Ag | 29 August 2023 | 1 |
| Rising Pharma Holding Inc | 11 September 2023 | 1 |
| Aurobindo Pharma Ltd | 26 September 2024 | 1 |
| Neocubes Pharma Llp | 1 June 2026 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Suspension, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Myhibbin. No generic is listed as marketed.
Patents and exclusivities still listed
- 16 August 2039Patent 12194143 drug product
- 16 August 2039Patent 12097285 drug product
- 16 August 2039Patent 12226526 drug product
- 16 August 2039Patent 11931455 drug product
- 16 August 2039Patent 12097284 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.