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TRYPTYR

NDA

ACOLTREMON | N217370 | ALCON LABORATORIES INC

1 strength5 unique patents1 unique exclusivity

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Sep. 8, 2031

Sep. 8, 2031

Sep. 8, 2031

Dec. 16, 2042

Dec. 16, 2042

NCE

May. 28, 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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Long-term Effects of Acoltremon vs. Control in Dry Eye Disease NCT07659626	—	Not Yet Recruiting	The Eye Care Institute	60	2026-07-20 → 2029-07-20

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 29, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.003%

RLD

5 patents1 exclusivity▴

SOLUTION/DROPS;OPHTHALMIC | Approved: May 28, 2025

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9095609	Sep 8, 2031	—	—	Yes	—
9433679	Sep 8, 2031	—	—	—	—
10028920	Sep 8, 2031	—	—	—	—
11850221	Dec 16, 2042	—	—	Yes	—
12336971	Dec 16, 2042	—	—	—	—

Exclusivities (1)

Code	Date	Status
NCE	May 28, 2030	Active