COSOPT (nda020869)- (EQ 2% BASE;EQ 0.5% BASE)

Generic Name	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	Innovator	THEA PHARMA
Dosage	EQ 2% BASE;EQ 0.5% BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	COSOPT is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a betaadrenergic receptor blocking agent, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers. The IOP-lowering of COSOPT twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
13	0	10

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 2% BASE;EQ 0.5% BASE	**	**	-	-	7

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	8

Manufacturing Details of COSOPT