COMBIGAN (nda021398)- (0.2%;EQ 0.5% BASE)

Generic Name	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	Innovator	ABBVIE
Dosage	0.2%;EQ 0.5% BASE
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2023-Jan-19	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	COMBIGAN® is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of COMBIGAN® dosed twice a day was slightly less than that seen with the concomitant administration of timolol maleate ophthalmic solution, 0.5% dosed twice a day and brimonidine tartrate ophthalmic solution, 0.2% dosed three times per day.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	1	7

Other Developers

Total Other Developers	23

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.2%;EQ 0.5% BASE	**	**	Up	-	6

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	5

Manufacturing Details of COMBIGAN