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COMBIGAN

NDA

BRIMONIDINE TARTRATE; TIMOLOL MALEATE | N021398 | ABBVIE 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
ALLERGAN SALES, LLC et al v. SANDOZ, INC. et al 2:2017cv10129 9 patentsANDA 91-087Brimonidine tartrate/Timolol maleate	D.N.J.	2017-10-30	Terminated 2022-01-28	—
Allergan Sales, LLC v. Sandoz, Inc. 2:2015cv00347 4 patentsANDA 091087brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5%	E.D. Tex.	2015-03-09	Terminated 2016-12-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 Combigan (2023)

Total Spending

$232.1M

Total Claims

610,114

Beneficiaries

144,502

Avg Cost/Unit

$43.40

Spending Trend

$359.3M(2019)→$379.4M(2020)→$392.7M(2021)→$292.0M(2022)→$232.1M(2023)

YoY Change:+2.8%

5yr CAGR:+5.0%

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.2%;EQ 0.5% BASE

RLDAB

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Oct 30, 2007

No patent or exclusivity listings for this strength.