MARIBAVIR | N215596 | TAKEDA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
TAKEDA PHARMACEUTICAL COMPANY LIMITED v. QILU PHARMACEUTICAL (HAINAN) CO., LTD. 1 patentANDA 221142maribavir | D.N.J. | 2026-04-17 | Active | — |
TAKEDA PHARMACEUTICAL COMPANY LIMITED v. SUN PHARMACEUTICAL INDUSTRIES LTD. 6 patentsANDA 219690maribavir | D.N.J. | 2026-02-26 | Active | — |
TAKEDA PHARMACEUTICAL COMPANY LIMITED v. ANNORA PHARMA PRIVATE LIMITED 6 patentsANDA 221113maribavir | D.N.J. | 2026-02-23 | Active | — |
TAKEDA PHARMACEUTICAL COMPANY LIMITED v. QILU PHARMACEUTICAL (HAINAN) CO., LTD. 6 patentsANDA 221142maribavir | D.N.J. | 2026-02-18 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Grace Consulting Services, Inc (on behalf of Annora... FDA-2025-P-1926 Grace Consulting Services Inc., on behalf of Annora Pharma Private Limited, filed a suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to submit an ANDA for Maribavir 200 mg and 400 mg film-coated tablets, referencing the listed drug LIVTENCITY (maribavir) 200 mg | Suitability | 2025-06-25 | Open | Grace Consulting Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| NCE | Nov 23, 2026 | < 1 year |
| ODE-388 | Nov 23, 2028 | Active |