TERIPARATIDE | N021318 | ELI LILLY AND CO
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED et al v. ELI LILLY AND COMPANY 1 patentANDA 215844Teriparatide | S.D. Ind. | 2022-06-02 | Terminated 2022-10-21 | — |
| D. Del. | 2021-07-28 | Terminated 2021-09-13 | — | |
Eli Lilly and Company v. Radius Health, Inc. 1 patentteriparatide [rDNA origin] injection; abaloparatide | D. Del. | 2021-07-08 | Terminated 2021-08-10 | — |
| S.D. Ind. | 2021-06-29 | Terminated 2021-10-01 | — | |
| D. Del. | 2018-04-05 | Terminated 2018-07-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Amneal Pharmaceuticals FDA-2017-P-6274 · 7 docket documents Amneal Pharmaceuticals filed this citizen petition pursuant to Section 505(j)(2)(C) and Section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving any Abbreviated New Drug Applications for synthetically derived Teriparatide injection products as generic | 505(q) | 2017-10-26 | Denied | Amneal Pharmaceuticals |
Citizen Petition from Eli Lilly and Company FDA-2016-P-2515 · 27 docket documents Eli Lilly and Company filed this citizen petition on August 18, 2016, requesting that the FDA refuse to approve any abbreviated new drug application (ANDA) citing Forteo (teriparatide injection) as the reference listed drug, including ANDA No. 208569 submitted by Teva Pharmaceuticals USA Inc., and i | 505(q) | 2016-08-23 | Denied | Eli Lilly and Company |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1842.24
per ml
Lowest NADAC/Unit
$536.55
per ml
Brand NDCs
2
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00002840001FORTEO 560 MCG/2.24 ML PEN INJ | $1842.24 | ML | Brand | $536.55 | 2026-06-17 |
| 00002967801FORTEO 560 MCG/2.24 ML PEN INJ | $1842.24 | ML | Brand | $536.55 | 2026-06-17 |
| 66993049528TERIPARATIDE 560 MCG/2.24 ML PEN | $536.55 | ML | Generic | — | 2026-06-17 |
| 66993098928TERIPARATIDE 560 MCG/2.24 ML PEN | $536.55 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.