COSOPT PF (nda202667)- (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 PF is a carbonic anhydrase inhibitor with 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
3	0	3

Other Developers

Total Other Developers	2

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	**	**	Up	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of COSOPT PF