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COSOPT

NDA

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | N020869 | THEA PHARMA INC

1 strength0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Cosopt (2023)

Total Spending

$520K

Total Claims

1,662

Beneficiaries

660

Avg Cost/Unit

$21.39

Spending Trend

$110K(2019)→$548K(2020)→$589K(2021)→$596K(2022)→$520K(2023)

YoY Change:+7.5%

5yr CAGR:+2.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Nov 25, 2020	SUPPL -42	View Letter (PDF)
Aug 3, 2015	SUPPL -40	View Letter (PDF)
Jun 22, 2010	SUPPL -36	View Letter (PDF)
Oct 23, 2008	SUPPL -34	View Letter (PDF)
Aug 14, 2006	SUPPL -30	View Letter (PDF)
May 1, 2006	SUPPL -28	View Letter (PDF)
May 1, 2006	SUPPL -26	View Letter (PDF)
Dec 15, 2005	SUPPL -22	View Letter (PDF)
Mar 30, 2005	SUPPL -20	View Letter (PDF)
Apr 23, 2002	SUPPL -12	View Letter (PDF)
Apr 7, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2% BASE;EQ 0.5% BASE

RLDAT1

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Apr 7, 1998

No patent or exclusivity listings for this strength.