DEXLANSOPRAZOLE | N022287 | TAKEDA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Takeda Pharmaceutical Co., Ltd. et al v. Mylan Inc et al 1 patentANDA 205205dexlansoprazole | N.D. Cal. | 2014-01-21 | Terminated 2015-04-21 | — |
Par Pharmaceutical, Inc. et al v. Takeda Pharmaceutical Co., Ltd. et al 1 patentANDA 202-294dexlansoprazole | N.D. Cal. | 2013-07-09 | Terminated 2013-08-08 | — |
| N.D. Cal. | 2013-05-29 | Terminated 2013-10-22 | — | |
Takeda Pharmaceutical Co., Ltd. et al v. IMPAX Laboratories, Inc. 1 patentANDA 202576dexlansoprazole | N.D. Cal. | 2013-05-29 | Terminated 2014-12-01 | — |
Par Pharmaceutical, Inc. et al v. Takeda Pharmaceutical Co., Ltd. et al 2 patentsANDA 202-294dexlansoprazole | N.D. Cal. | 2013-04-26 | Terminated 2014-09-05 | — |
Takeda Pharmaceutical Co., Ltd. et al v. Sandoz, Inc. 5 patentsANDA 203504dexlansoprazole | N.D. Cal. | 2012-01-27 | Terminated 2013-10-22 | — |
Takeda Pharmaceutical Co., Ltd. et al v. Dr. Reddy's Laboratories, Ltd. et al 2 patentsANDA 202193dexlansoprazole | S.D.N.Y. | 2011-04-01 | Terminated 2011-05-16 | — |
Takeda Pharmaceutical Co., Ltd. et al v. Impax Laboratories, Inc., 5 patentsANDA 202-576dexlansoprazole | N.D. Cal. | 2011-04-01 | Terminated 2013-11-01 | — |
Takeda Pharmaceutical Co., Ltd. et al v. Dr. Reddy's Laboratories, LTD. et al 2 patentsANDA 202-193dexlansoprazole | N.D. Cal. | 2011-03-31 | Terminated 2011-05-11 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alliance For Natural Health USA FDA-2020-P-1540 · 5 docket documents Alliance for Natural Health USA filed this citizen petition requesting that the Food and Drug Administration issue a regulation requiring all manufacturers of proton pump inhibitor medications, including omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole, and dexlansoprazole, to expan | 505(q) | 2020-06-11 | Denied | Alliance For Natural Health USA |
Takeda Pharmaceuticals U.S.A., Inc. - Citizen Petition FDA-2013-P-0198 · 4 docket documents Takeda Pharmaceuticals U.S.A., Inc. filed this citizen petition under 21 USC 355 and 21 CFR 10.30 on February 15, 2013, requesting that the FDA refrain from approving any abbreviated new drug application (ANDA) referencing DEXILANT (dexlansoprazole) delayed-release capsules unless the applicant prov | 505(q) | 2013-03-08 | Denied | — |
Public Citizens Health Research Group - Citizen Petition FDA-2011-P-0741 · 4 docket documents Public Citizen's Health Research Group filed this citizen petition pursuant to 21 U.S.C. § 352 and 21 C.F.R. §§ 10.30 and 201.56 requesting that the FDA immediately add black box warnings and other enhanced safety labeling to all proton pump inhibitors including Nexium, Dexilant, Prilosec, Zegerid, | Other | 2011-10-20 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$9.84
per ea
Lowest NADAC/Unit
$9.84
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 64764017130DEXILANT DR 30 MG CAPSULE | $9.84 | EA | Brand | $4.16 | 2026-06-17 |
| 64764017530DEXILANT DR 60 MG CAPSULE | $9.84 | EA | Brand | $3.84 | 2026-06-17 |
| 64764017590DEXILANT DR 60 MG CAPSULE | $9.84 | EA | Brand | $3.84 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7790755 | Aug 2, 2026PED: Feb 2, 2027 | PED | — | Yes | — | — |
| 8105626 | Sep 27, 2026PED: Mar 27, 2027 | PED | — | Yes | — | — |
| 8173158 | Mar 17, 2030PED: Sep 17, 2030 | PED | — | — | — | |
| 8461187 | Jan 17, 2026PED: Jul 17, 2026 | PED | — | Yes | — | — |
| 8871273 | Jan 11, 2028 | — | — | Yes | — | — |
| 9011926 | Feb 24, 2026 | — | — | Yes | — | — |
| 9233103 | Mar 5, 2032 | — | — | — | — | |
| 9238029 | Jan 17, 2026 | — | — | Yes | — | — |