Generic competition · all medicines · read 12 November 2026
Is there a generic of Diltiazem Hydrochloride, and who makes it?
Diltiazem Hydrochloride appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 26 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 4.3 and 10 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.
- Diltiazem Hydrochloride appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 26 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 4.3 and 10 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, Extended Release, Oral
Four or more generic makers listed
Brand listed as marketed: Cardizem Cd and Tiazac. 17 generic makers with 81 generic products listed as marketed; the first generic approval is dated 30 November 1993.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Mylan Pharmaceuticals Inc | 2 May 1997 | 3 |
| Actavis Laboratories Fl Inc | 9 July 1998 | 4 |
| Apotex Inc | 6 August 1998 | 3 |
| Ph Health Ltd | 20 December 1999 | 4 |
| Valeant Pharmaceuticals North America Llc | 23 December 1999 | 4 |
| Chartwell Rx Sciences Llc | 28 September 2012 | 6 |
| Actavis Elizabeth Llc | 7 December 2012 | 1 |
| Sun Pharmaceutical Industries Ltd | 8 June 2017 | 1 |
| Zydus Pharmaceuticals Usa Inc | 8 August 2017 | 11 |
| Twi Pharmaceuticals Inc | 30 August 2018 | 8 |
| Novast Laboratories Ltd | 14 June 2019 | 8 |
| Accord Healthcare Inc | 28 April 2020 | 3 |
5 more makers are listed in the data.
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: Cardizem. 5 generic makers with 20 generic products listed as marketed; the first generic approval is dated 5 November 1992.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Teva Pharmaceuticals Usa Inc | 31 May 1995 | 4 |
| Sciegen Pharmaceuticals Inc | 23 September 2022 | 4 |
| Zydus Lifesciences Global Fze | 8 August 2025 | 4 |
| Alembic Pharmaceuticals Ltd | 14 November 2025 | 4 |
| Yichang Humanwell Pharmaceutical Co Ltd | 25 September 2026 | 4 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Extended Release, Oral
One to three generic makers listed
Brand listed as marketed: Cardizem La. 3 generic makers with 18 generic products listed as marketed; the first generic approval is dated 15 March 2010.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Actavis Laboratories Fl Inc | 15 March 2010 | 6 |
| Amta Labs Ltd | 7 March 2023 | 6 |
| Sciegen Pharmaceuticals Inc | 6 April 2023 | 6 |
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. 4 generic makers with 4 generic products listed as marketed; the first generic approval is dated 28 February 1996.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Sagent Pharmaceuticals | 28 February 1996 | 1 |
| Rising Pharma Holdings Inc | 9 April 1998 | 1 |
| Hospira Inc | 17 December 2002 | 1 |
| Hikma Pharmaceuticals Usa Inc | 17 December 2008 | 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: Diltiazem Hydrochloride In 0.72% 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.