FDA Orange Book · active-ingredient family
Lansoprazole
Lansoprazole is approved as 6 brand and 30 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PREVACID 24 HR · NDA 022327
6
Brand (NDA)
30
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, delayed rel pellets, for suspension, delayed release, injectable, tablet, orally disintegrating, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PREVACID 24 HRRLD | PERRIGO PHARMA INTL | NDA 022327 | — | May 18, 2009 | |
| PREVACID IVRLD | TAKEDA PHARMS NA | NDA 021566 | — | May 27, 2004 | |
| PREVACIDRLD×2 | TAKEDA PHARMS USA | NDA 021428 | AB | Aug 30, 2002 | |
| PREVACIDRLD×2 | TAKEDA PHARMS USA | NDA 020406 | — | May 10, 1995 | |
| LANSOPRAZOLE | DEXCEL | NDA 208025 | — | Jun 07, 2016 | |
| PREVACID×2 | TAKEDA PHARMS NA | NDA 021281 | — | May 03, 2001 |
Generic (ANDA) products (30)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LANSOPRAZOLE×2 | MACLEODS PHARMS LTD | ANDA 208671 | — | Nov 04, 2024 | |
| LANSOPRAZOLE×2 | AUROBINDO PHARMA LTD | ANDA 207167 | AB | Mar 28, 2023 | |
| LANSOPRAZOLE×2 | DR REDDYS | ANDA 210465 | AB | Feb 01, 2021 | |
| LANSOPRAZOLE×2 | HETERO LABS LTD III | ANDA 203083 | AB | May 18, 2020 | |
| LANSOPRAZOLE×2 | ALKEM LABS LTD | ANDA 207394 | AB | Jan 18, 2019 | |
| LANSOPRAZOLE×2 | MYLAN | ANDA 202396 | AB | Nov 28, 2018 | |
| LANSOPRAZOLE×2 | ZYDUS PHARMS | ANDA 200816 | AB | Nov 27, 2018 | |
| LANSOPRAZOLE×2 | NOVITIUM PHARMA | ANDA 203964 | — | Oct 17, 2018 | |
| LANSOPRAZOLE | LANNETT CO INC | ANDA 207157 | — | Sep 29, 2017 | |
| LANSOPRAZOLE×2 | CHARTWELL MOLECULAR | ANDA 207156 | AB | Sep 28, 2017 | |
| LANSOPRAZOLE×2 | TEVA PHARMS USA | ANDA 208784 | AB | Sep 21, 2017 | |
| LANSOPRAZOLE×2 | INVENTIA | ANDA 205868 | AB | Aug 30, 2017 | |
| LANSOPRAZOLE×2 | AJANTA PHARMA LTD | ANDA 203957 | — | Oct 14, 2016 | |
| LANSOPRAZOLE×2 | XIROMED | ANDA 203203 | AB | Jul 25, 2016 | |
| LANSOPRAZOLE | MYLAN | ANDA 203187 | — | Jun 01, 2016 | |
| LANSOPRAZOLE | NATCO | ANDA 203306 | — | Jan 13, 2016 | |
| LANSOPRAZOLE×2 | KRKA TOVARNA ZDRAVIL | ANDA 091212 | — | Sep 16, 2013 | |
| LANSOPRAZOLE | SUN PHARM | ANDA 202637 | — | Sep 13, 2013 | |
| LANSOPRAZOLE | SUN PHARM | ANDA 091509 | — | Sep 13, 2013 | |
| LANSOPRAZOLE×2 | ZYDUS HLTHCARE | ANDA 202366 | AB | Aug 19, 2013 | |
| LANSOPRAZOLE×2 | NATCO PHARMA LTD | ANDA 201921 | AB | Dec 18, 2012 | |
| LANSOPRAZOLE×2 | APOTEX | ANDA 202176 | AB | Sep 14, 2012 | |
| LANSOPRAZOLE | DR REDDYS LABS LTD | ANDA 202194 | — | May 18, 2012 | |
| LANSOPRAZOLE | GLENMARK PHARMS | ANDA 202727 | — | May 18, 2012 | |
| LANSOPRAZOLE | PERRIGO R AND D | ANDA 202319 | — | May 18, 2012 | |
| LANSOPRAZOLE×2 | DR REDDYS LABS LTD | ANDA 091269 | AB | Oct 15, 2010 | |
| LANSOPRAZOLE×2 | ANI PHARMS | ANDA 078730 | — | Oct 15, 2010 | |
| LANSOPRAZOLE×2 | SANDOZ | ANDA 090331 | — | Apr 23, 2010 | |
| LANSOPRAZOLE×2 | MYLAN PHARMS INC | ANDA 090763 | AB | Nov 10, 2009 | |
| LANSOPRAZOLE×2 | TEVA PHARMS | ANDA 077255 | AB | Nov 10, 2009 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11077055 | Apr 21, 2036 | in 10 yr | Product |
| 11986554 | Apr 21, 2036 | in 10 yr | Product |
Lansoprazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
