Generic competition · all medicines · read 12 November 2026
Is there a generic of Labetalol Hydrochloride, and who makes it?
Labetalol Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 19 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 14 and 14.8 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.
- Labetalol Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 19 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 14 and 14.8 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 38 generic products listed as marketed; the first generic approval is dated 3 August 1998.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Heritage Pharma Labs Inc | 3 August 1998 | 4 |
| Watson Laboratories Inc | 3 August 1998 | 3 |
| Aiping Pharmaceutical Inc | 4 August 1998 | 3 |
| Innogenix Llc | 29 July 1999 | 3 |
| Zydus Pharmaceuticals Usa Inc | 19 September 2017 | 3 |
| Appco Pharma Llc | 20 June 2018 | 4 |
| Adaptis Pharma Private Ltd | 4 February 2019 | 3 |
| Cadila Pharmaceuticals Ltd | 13 May 2019 | 3 |
| Epic Pharma Llc | 30 September 2020 | 3 |
| Rubicon Research Ltd | 18 August 2021 | 3 |
| Unichem Laboratories Ltd | 8 August 2022 | 3 |
| Macleods Pharmaceuticals Ltd | 23 September 2025 | 3 |
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
Every brand product here is listed as discontinued. 7 generic makers with 8 generic products listed as marketed; the first generic approval is dated 28 May 1999.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hikma Pharmaceuticals Usa Inc | 28 May 1999 | 1 |
| Hospira Inc | 29 November 1999 | 2 |
| Rising Pharma Holdings Inc | 29 November 1999 | 1 |
| Baxter Healthcare Corp | 5 July 2002 | 1 |
| Gland Pharma Ltd | 3 April 2012 | 1 |
| Caplin Steriles Ltd | 7 September 2021 | 1 |
| Amneal Eu Ltd | 2 October 2025 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Intravenous
Brand listed, no generic listed as marketed
Brand listed as marketed: Labetalol Hydrochloride, Labetalol Hydrochloride In Dextrose and Labetalol Hydrochloride In Sodium Chloride. 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.