ALDARA (nda020723)- (5%)

Generic Name	IMIQUIMOD	Innovator	BAUSCH
Dosage	5%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2024-Oct-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Aldara Cream is indicated for the topical treatment of: • Clinically typical, non hyperkeratotic, non hypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adult. • Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults; maximum tumor diameter of 2.0 cm on trunk, neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. • External genital and perianal warts/condyloma acuminata in patients 12 years old or older

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	4

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
5%	**	**	-	3	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	4

Manufacturing Details of ALDARA