LYRICA (nda021446)- (25MG,50MG,75MG,100MG,150MG,200MG,225MG,300MG)

Generic Name	PREGABALIN	Innovator	UPJOHN
Dosage	25MG,50MG,75MG,100MG,150MG,200MG,225MG,300MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2019-Jun-30	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LYRICA is indicated for:  Neuropathic pain associated with diabetic peripheral neuropathy (DPN)  Postherpetic neuralgia (PHN)  Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older  Fibromyalgia  Neuropathic pain associated with spinal cord injury

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
30	6	21

Other Developers

Total Other Developers	7

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
25MG	**	**	-	12	1
50MG	**	**	Up	15	1
75MG	**	**	Up	14	1
100MG	**	**	Up	14	1
150MG	**	**	Up	15	1
200MG	**	**	Up	14	1
225MG	**	**	Up	-	14
300MG	**	**	Up	-	15

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	15

Manufacturing Details of LYRICA