FDA Orange Book · active-ingredient family
Rabeprazole sodium
Rabeprazole sodium is approved as 2 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ACIPHEX SPRINKLE · NDA 204736
2
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, delayed release, tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACIPHEX SPRINKLERLD×2 | AYTU | NDA 204736 | — | Mar 26, 2013 | |
| ACIPHEXRLD×2 | WAYLIS THERAP | NDA 020973 | — | May 29, 2002 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RABEPRAZOLE SODIUM | ALKEM LABS LTD | ANDA 208644 | AB | Apr 24, 2018 | |
| RABEPRAZOLE SODIUM | AUROBINDO PHARMA USA | ANDA 205761 | AB | Feb 17, 2017 | |
| RABEPRAZOLE SODIUM | RUBICON RESEARCH | ANDA 204237 | AB | Nov 18, 2015 | |
| RABEPRAZOLE SODIUM | AMNEAL PHARMS | ANDA 204179 | AB | Jul 31, 2015 | |
| RABEPRAZOLE SODIUM | CHARTWELL RX | ANDA 078964 | AB | Nov 08, 2013 | |
| RABEPRAZOLE SODIUM | DR REDDYS | ANDA 076824 | AB | Nov 08, 2013 | |
| RABEPRAZOLE SODIUM | LANNETT CO INC | ANDA 090678 | AB | Nov 08, 2013 | |
| RABEPRAZOLE SODIUM | PHARMOBEDIENT | ANDA 076885 | — | Nov 08, 2013 | |
| RABEPRAZOLE SODIUM | TEVA PHARMS USA | ANDA 076822 | — | Nov 08, 2013 | |
| RABEPRAZOLE SODIUM | TORRENT | ANDA 202376 | AB | Nov 08, 2013 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Rabeprazole sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
