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NDA

ELAFIBRANOR | N218860 | IPSEN BIOPHARMACEUTICALS INC

1 strength9 unique patents2 unique exclusivities

Patent Timeline

9 unique patents, 2 exclusivities by expiration date

Active (9)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Mar. 30, 2037

Mar. 30, 2037

Mar. 30, 2037

Mar. 30, 2037

Mar. 30, 2037

Mar. 30, 2037

Mar. 30, 2037

Mar. 30, 2037

Mar. 30, 2037

NCE

Jun. 10, 2029

ODE-486

Jun. 10, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov — 4 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)NCT06730061	Phase 3	Active	Ipsen	18	2025-01-16 → 2032-04-08
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy NCT07556913	—	Not Yet Recruiting	Ipsen	3	2026-08-15 → 2039-01-31
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment NCT06447168	—	Recruiting	Ipsen	424	2024-10-14 → 2032-07-15
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis NCT07387549	Phase 3	Recruiting	Ipsen	350	2026-05-14 → 2031-05-31
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis NCT06016842	Phase 3	Recruiting	Ipsen	276	2023-08-31 → 2029-05-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 11, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 80MG

RLD

9 patents2 exclusivities▴

TABLET;ORAL | Approved: Jun 10, 2024

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11185519	Mar 30, 2037	—	—	—		—
11331292	Mar 30, 2037	—	—	—		—
11850223	Mar 30, 2037	—	—	—		—
11857523	Mar 30, 2037	—	—	—		—
12233038	Mar 30, 2037	—	—	—		—
12295927	Mar 30, 2037	—	—	—		—
12295928	Mar 30, 2037	—	—	—		—
12310935	Mar 30, 2037	—	—	—		—
12589086	Mar 30, 2037	—	—	—	U-4473	—

Exclusivities (2)

Code	Date	Status
NCE	Jun 10, 2029	Active
ODE-486	Jun 10, 2031	Active