Viewing data from:

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

13 trials from ClinicalTrials.gov, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension NCT00822081	Phase 4	Completed	Bp Consulting, Inc	140	2005-01 → 2006-04
Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension NCT00822055	Phase 4	Completed	Allergan	140	2005-05 → 2006-11
Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®NCT01170884	Phase 4	Completed	Allergan	121	2009-12 → 2010-09
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension NCT01217606	Phase 3	Completed	Allergan	185	2011-01 → 2015-06
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension NCT01241240	Phase 3	Completed	Allergan	192	2011-03 → 2013-09
Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension NCT01216943	Phase 3	Completed	Allergan	126	2010-11 → 2012-08
Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension NCT01229462	N/A	Completed	Allergan	238	2010-10 → 2011-09
An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects NCT00811564	Phase 4	Completed	Allergan	148	2008-12 → 2010-01
Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)NCT02863705	Phase 4	Completed	Allergan	118	2016-07-05 → 2018-07-25
Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow NCT00811850	Phase 4	Completed	Allergan	15	2008-12 → 2009-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 6 NDCs (3 brand, 3 generic)

Highest NADAC/Unit

$39.18

per ml

Lowest NADAC/Unit

$2.10

per ml

Brand NDCs

Generic NDCs

Avg Brand: $39.14

Avg Generic: $2.53

94% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00023921105COMBIGAN 0.2%-0.5% EYE DROPS	$39.18	ML	Brand	$2.88	2026-06-17
00023921110COMBIGAN 0.2%-0.5% EYE DROPS	$39.12	ML	Brand	$2.60	2026-06-17
00023921115COMBIGAN 0.2%-0.5% EYE DROPS	$39.11	ML	Brand	$2.10	2026-06-17
82182045505BRIMONIDINE-TIMOLOL 0.2%-0.5%	$2.88	ML	Generic	—	2026-06-17
82182045510BRIMONIDINE-TIMOLOL 0.2%-0.5%	$2.60	ML	Generic	—	2026-06-17
82182045515BRIMONIDINE-TIMOLOL 0.2%-0.5%	$2.10	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 9 NDCs (6 FSS, 3 Big4)

Lowest Price

$18.10

Highest Price

$603.13

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82182-0455-05BRIMONIDINE TARTRATE 0.2%/TIMOLOL MALEATE 0.5	$18.10	FSS	Zydus Pharmaceuticals (USA) Inc.	08/14/2026
82182-0455-10BRIMONIDINE TARTRATE 0.2%/TIMOLOL MALEATE 0.5	$36.19	FSS	Zydus Pharmaceuticals (USA) Inc.	08/14/2026
82182-0455-15BRIMONIDINE TARTRATE 0.2%/TIMOLOL MALEATE 0.5	$54.29	FSS	Zydus Pharmaceuticals (USA) Inc.	08/14/2026
00023-9211-05COMBIGAN OPTH SOLN	$201.06	FSS	Abbvie US LLC	07/31/2030
00023-9211-05COMBIGAN OPTH SOLN	$152.79	Big4	Abbvie US LLC	07/31/2030
00023-9211-10COMBIGAN OPTH SOLN	$402.11	FSS	Abbvie US LLC	07/31/2030

Showing 6 of 9 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Combigan (2024)

Total Spending

$162.3M

Total Claims

465,280

Beneficiaries

114,398

Avg Cost/Unit

$38.75

Spending Trend

$359.3M(2019)→$379.4M(2020)→$392.7M(2021)→$292.0M(2022)→$232.1M(2023)→$162.3M(2024)

YoY Change:-10.7%

5yr CAGR:+0.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Mar 19, 2026	SUPPL -9	View Letter (PDF)
Oct 16, 2015	SUPPL -7	View Letter (PDF)
Oct 15, 2012	SUPPL -6	View Letter (PDF)
Nov 8, 2007	ORIG -1	View Letter (PDF)

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.