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QFITLIA (FITUSIRAN SODIUM) | 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
QFITLIA
NDA
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FITUSIRAN SODIUM | N219019 | GENZYME CORP
2 strengths
3 unique patents
3 unique exclusivities
Patents
SEC Intel
Revenue
PTAB
Reexams
Litigation
Petitions
Trials
Approvals
Label
Products
Patent Timeline
3 unique patents, 3 exclusivities by expiration date
All strengths
EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML)
EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML)
Active (3)
Today
Exclusivity
2026
2027
2028
2029
2030
2031
2032
2033
2034
2035
2036
2037
Today
9127274
Mar. 22, 2033
9376680
Mar. 15, 2033
11091759
Dec. 7, 2036
NCE
Mar. 28, 2030
ODE-510
Mar. 28, 2032
ODE-511
Mar. 28, 2032
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 (2)
Sort:
Name
↑
Applicant
Strength
Approval
#001 — EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML)
RLD
3 patents
3 exclusivities
▴
SOLUTION;SUBCUTANEOUS | Approved: Mar 28, 2025
Patents (3)
Patent #
Expiration
PED
Drug Substance
Drug Product
Use Code
Delist
9127274
Mar 22, 2033
—
Yes
Yes
U-4165
ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA A OR B WITH OR WITHOUT FACTOR VIII OR IX INHIBITORS
—
9376680
Mar 15, 2033
—
Yes
Yes
U-4165
ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA A OR B WITH OR WITHOUT FACTOR VIII OR IX INHIBITORS
—
11091759
Dec 7, 2036
—
—
—
U-4165
ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA A OR B WITH OR WITHOUT FACTOR VIII OR IX INHIBITORS
—
Exclusivities (3)
Code
Date
Status
NCE
Mar 28, 2030
Active
ODE-510
Mar 28, 2032
Active
ODE-511
Mar 28, 2032
Active
#002 — EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML)
RLD
3 patents
3 exclusivities
▾
SOLUTION;SUBCUTANEOUS | Approved: Mar 28, 2025