FDA Orange Book · active-ingredient family
Ramipril
Ramipril is approved as 3 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VOSTALLY · NDA 219757
3
Brand (NDA)
17
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VOSTALLYRLD | ROSEMONT PHARMS | NDA 219757 | — | Jul 23, 2025 | |
| ALTACERLD×4 | KING PFIZER | NDA 022021 | — | Feb 27, 2007 | |
| ALTACERLD×4 | KING PHARMS LLC | NDA 019901 | — | Jan 28, 1991 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RAMIPRIL×4 | APOTEX | ANDA 091069 | — | Dec 02, 2015 | |
| RAMIPRIL×4 | ACCORD HLTHCARE | ANDA 202392 | — | Apr 15, 2014 | |
| RAMIPRIL×4 | NATCO PHARMA | ANDA 090650 | — | Jun 30, 2011 | |
| RAMIPRIL×4 | AUROBINDO PHARMA LTD | ANDA 091604 | AB | Jun 08, 2011 | |
| RAMIPRIL×4 | ZYDUS PHARMS USA INC | ANDA 090697 | — | Sep 24, 2009 | |
| RAMIPRIL×2 | RANBAXY LABS LTD | ANDA 078849 | — | Mar 06, 2009 | |
| RAMIPRIL×4 | ZYDUS PHARMS USA | ANDA 078832 | AB | Sep 02, 2008 | |
| RAMIPRIL×4 | CIPLA | ANDA 077004 | — | Aug 07, 2008 | |
| RAMIPRIL×4 | COREPHARMA | ANDA 079116 | AB | Jun 20, 2008 | |
| RAMIPRIL×4 | ACTAVIS ELIZABETH | ANDA 077513 | — | Jun 18, 2008 | |
| RAMIPRIL×4 | CHARTWELL MOLECULAR | ANDA 078745 | AB | Jun 18, 2008 | |
| RAMIPRIL×4 | CHARTWELL RX | ANDA 077514 | — | Jun 18, 2008 | |
| RAMIPRIL×4 | HIKMA | ANDA 077900 | AB | Jun 18, 2008 | |
| RAMIPRIL×4 | SENORES PHARMS | ANDA 078191 | AB | Jun 18, 2008 | |
| RAMIPRIL×4 | TEVA PHARMS | ANDA 077470 | — | Jun 18, 2008 | |
| RAMIPRIL×4 | LUPIN | ANDA 077626 | AB | Jun 09, 2008 | |
| RAMIPRIL×4 | WATSON LABS | ANDA 076549 | AB | Oct 24, 2005 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12343338 | Aug 16, 2039 | in 13 yr 4 mo | ProductU-4233 |
Ramipril — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

