Generic competition · all medicines · read 12 November 2026
Is there a generic of Morphine Sulfate, and who makes it?
Morphine Sulfate appears in 8 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 between 2.1 and 15.4 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.
- Morphine Sulfate appears in 8 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 between 2.1 and 15.4 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, Extended Release, Oral
Four or more generic makers listed
Brand listed as marketed: Ms Contin. 4 generic makers with 16 generic products listed as marketed; the first generic approval is dated 2 July 1998.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Rhodes Pharmaceuticals Lp | 2 July 1998 | 5 |
| Dava Pharmaceuticals Inc | 28 January 2000 | 1 |
| Specgx Llc | 3 July 2003 | 5 |
| Sun Pharmaceutical Industries Ltd | 11 May 2012 | 5 |
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
Every brand product here is listed as discontinued. 2 generic makers with 13 generic products listed as marketed; the first generic approval is dated 10 November 2011.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Actavis Elizabeth Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc | 16 January 2013 | 6 |
| Upsher Smith Laboratories Llc | 3 June 2013 | 7 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Injectable, Injection
Four or more generic makers listed
Brand listed as marketed: Duramorph Pf, Infumorph and Morphine Sulfate. 4 generic makers with 13 generic products listed as marketed; the first generic approval is dated 7 October 1986.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hospira Inc | 30 September 1992 | 2 |
| Hikma Pharmaceuticals Usa Inc | 21 May 2015 | 8 |
| Piramal Critical Care Inc | 16 July 2018 | 2 |
| International Medication Systems Ltd | 29 April 2021 | 1 |
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: Morphine Sulfate. 5 generic makers with 10 generic products listed as marketed; the first generic approval is dated 15 July 2011.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Specgx Llc | 15 July 2011 | 1 |
| Tris Pharma Inc | 12 May 2015 | 1 |
| Pharmaceutical Associates Inc | 14 November 2016 | 2 |
| Winder Laboratoiries Llc | 12 February 2021 | 3 |
| Quagen Pharmaceuticals Llc | 7 July 2026 | 3 |
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: Morphine Sulfate. 3 generic makers with 6 generic products listed as marketed; the first generic approval is dated 22 July 2019.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Upsher Smith Laboratories Llc | 22 July 2019 | 2 |
| Alkem Laboratories Ltd | 3 December 2020 | 2 |
| Specgx Llc | 21 August 2023 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Intramuscular, Intravenous
Brand listed, no generic listed as marketed
Brand listed as marketed: Morphine Sulfate. No generic is listed as marketed.
Patents and exclusivities still listed
- 12 March 2034Patent 9192608
- 12 March 2034Patent 9248229 drug product
- 12 March 2034Patent 9072781 drug product
Injectable, Liposomal, Epidural
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, Intramuscular
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.