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DIFICID (FIDAXOMICIN) | LOERadar
Viewing data from:
Latest
2026-07-01
2026-06-01
2026-05-01
2026-04-01
2026-03-28
2026-02-17
2026-02-10
2025-12-14
2025-02-26
2025-01-25
2024-11-08
2023-07-23
2023-06-15
2023-05-13
2023-01-26
2022-11-22
2022-10-28
2022-09-29
2022-07-09
2022-06-29
2022-04-08
2022-03-09
2021-12-28
2021-05-05
2021-03-12
2020-12-22
2020-11-12
2019-12-14
2019-09-15
DIFICID
NDA
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FIDAXOMICIN | N213138 | CUBIST PHARMACEUTICALS LLC
1 strength
5 unique patents
1 unique exclusivity
Patents
SEC Intel
Revenue
PTAB
Reexams
Litigation
Petitions
Trials
DMF
Approvals
Label
Products
Patent Timeline
5 unique patents, 1 exclusivity by expiration date
Expiring < 1yr (1)
Active (4)
Today
PED (+6 mo)
Exclusivity
2027
2028
2029
2030
2031
2032
2033
2034
2035
Today
7378508
Jan. 31, 2028
7863249
Jan. 31, 2028
7906489
Sep. 4, 2027
8859510
Jan. 31, 2028
9808530
Nov. 28, 2034
ODE-367
Jan. 24, 2027
PTAB Proceedings
No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board
Hatch-Waxman Litigation
No ANDA patent litigation cases (NOS 835) matched from PACER
Citizen Petitions
No FDA citizen petitions matched from Regulations.gov
Products (1)
#001 — 40MG/ML
RLD
5 patents
1 exclusivity
▴
FOR SUSPENSION;ORAL | Approved: Jan 24, 2020
Patents (5)
Patent #
Expiration
PED
Drug Substance
Drug Product
Use Code
Delist
7378508
Jul 31, 2027
PED: Jan 31, 2028
PED
Yes
Yes
—
—
7863249
Jul 31, 2027
PED: Jan 31, 2028
PED
—
Yes
—
—
7906489
Mar 4, 2027
PED: Sep 4, 2027
PED
—
—
U-2741
TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER
—
8859510
Jul 31, 2027
PED: Jan 31, 2028
PED
—
—
U-2741
TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER
—
9808530
May 28, 2034
PED: Nov 28, 2034
PED
—
Yes
—
—
Exclusivities (1)
Code
Date
Status
ODE-367
Jan 24, 2027
< 1 year