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NDA

BIRCH TRITERPENES | N215064 | CHIESI FARMACEUTICI SPA

1 strength6 unique patents2 unique exclusivities

Patent Timeline

6 unique patents, 2 exclusivities by expiration date

Expired (1)Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Jun. 21, 2026

Nov. 24, 2030

Nov. 24, 2030

Jan. 4, 2039

Jan. 4, 2039

Jan. 4, 2039

NCE

Dec. 18, 2028

ODE-460

Dec. 18, 2030

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

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 26, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10%

RLD

6 patents2 exclusivities▴

GEL;TOPICAL | Approved: Dec 18, 2023

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8828444	Jun 21, 2026	—	—	Yes	—	—
9352041	Nov 24, 2030	—	—	—		—
9827214	Nov 24, 2030	—	—	—		—
11083733	Jan 4, 2039	—	—	Yes	—	—
11266660	Jan 4, 2039	—	—	—		—
12268695	Jan 4, 2039	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Dec 18, 2028	Active
ODE-460	Dec 18, 2030	Active