Generic competition · all medicines · read 12 November 2026
Is there a generic of Hydromorphone Hydrochloride, and who makes it?
Hydromorphone Hydrochloride appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 8 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 4.2 and 11.6 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.
- Hydromorphone Hydrochloride appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 8 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 4.2 and 11.6 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.
Injectable, Injection
One to three generic makers listed
Brand listed as marketed: Dilaudid, Dilaudid-Hp and Hydromorphone Hydrochloride. 3 generic makers with 8 generic products listed as marketed; the first generic approval is dated 23 August 1995.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hospira Inc | 17 June 2008 | 1 |
| Rising Pharma Holdings Inc | 14 April 2010 | 2 |
| Hikma Pharmaceuticals Usa Inc | 27 April 2018 | 5 |
Patents and exclusivities still listed
- 23 April 2032Patent 9731082 drug product
- 12 March 2034Patent 9248229 drug product
Tablet, Extended Release, Oral
One to three generic makers listed
Every brand product here is listed as discontinued. 3 generic makers with 13 generic products listed as marketed; the first generic approval is dated 12 May 2014.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Padagis Us Llc | 6 April 2015 | 4 |
| Osmotica Pharmaceutical Us Llc | 7 July 2016 | 5 |
| Ascent Pharmaceuticals Inc | 23 September 2020 | 4 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Oral
One to three generic makers listed
Brand listed as marketed: Dilaudid. 3 generic makers with 9 generic products listed as marketed; the first generic approval is dated 29 July 1998.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Specgx Llc | 23 December 2004 | 3 |
| Aurolife Pharma Llc | 13 May 2016 | 3 |
| Ascent Pharmaceuticals Inc | 17 January 2018 | 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
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.
Solution, Oral
One to three generic makers listed
Brand listed as marketed: Dilaudid. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 29 July 1998.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hikma Pharmaceuticals Usa Inc | 29 July 1998 | 1 |
| Ascent Pharmaceuticals Inc | 27 October 2017 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Intramuscular, Intravenous, Subcutaneous
Brand listed, no generic listed as marketed
Brand listed as marketed: Hydromorphone Hydrochloride. No generic is listed as marketed.
Patents and exclusivities still listed
- 10 January 2043Patent 12653820 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.