Generic competition · all medicines · read 12 November 2026
Is there a generic of Cyclobenzaprine Hydrochloride, and who makes it?
Cyclobenzaprine Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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 6 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.
- Cyclobenzaprine Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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 6 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
Every brand product here is listed as discontinued. 12 generic makers with 33 generic products listed as marketed; the first generic approval is dated 3 May 1989.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Actavis Laboratories Fl Inc | 3 May 1989 | 3 |
| Aiping Pharmaceutical Inc | 19 November 1991 | 3 |
| Tp Anda Holdings Llc | 23 May 1995 | 4 |
| Jubilant Cadista Pharmaceuticals Inc | 19 April 2006 | 3 |
| Prinston Pharmaceutical Inc | 28 February 2007 | 2 |
| Chartwell Rx Sciences Llc | 18 April 2008 | 3 |
| Aurobindo Pharma Ltd | 26 September 2008 | 2 |
| Invagen Pharmaceuticals Inc | 23 July 2010 | 2 |
| Kvk Tech Inc | 28 February 2011 | 2 |
| Rubicon Research Ltd | 31 May 2017 | 3 |
| Unichem Laboratories Ltd | 5 July 2020 | 3 |
| Rising Pharma Holdings Inc | 12 September 2024 | 3 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Capsule, Extended Release, Oral
One to three generic makers listed
Brand listed as marketed: Amrix. 3 generic makers with 6 generic products listed as marketed; the first generic approval is dated 31 January 2013.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Twi Pharmaceuticals Inc | 31 January 2013 | 2 |
| Macleods Pharmaceuticals Ltd | 22 July 2024 | 2 |
| Novast Laboratories Ltd | 27 August 2024 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Sublingual
Brand listed, no generic listed as marketed
Brand listed as marketed: Tonmya. No generic is listed as marketed.
Patents and exclusivities still listed
- 15 August 2028Exclusivity NP Tonmya
- 14 March 2034Patent 10117936 drug product
- 14 March 2034Patent 10864175 drug product
- 14 March 2034Patent 9636408 drug product
- 14 March 2034Patent 9956188 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.