CIALIS (nda021368)- (2.5MG,5MG,10MG,20MG)

Generic Name	TADALAFIL	Innovator	LILLY
Dosage	2.5MG,5MG,10MG,20MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2021-May-19	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CIALIS ® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: • erectile dysfunction (ED) • the signs and symptoms of benign prostatic hyperplasia (BPH) • ED and the signs and symptoms of BPH (ED/BPH) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
24	0	21

Other Developers

Total Other Developers	22

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
2.5MG	**	**	-	-	16
5MG	**	**	Up	-	16
10MG	**	**	-	-	16
20MG	**	**	-	-	16

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	16

Manufacturing Details of CIALIS