DEPO-MEDROL (nda011757)- (20MG/ML,40MG/ML,80MG/ML)

Generic Name	METHYLPREDNISOLONE ACETATE	Innovator	PFIZER
Dosage	20MG/ML,40MG/ML,80MG/ML
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	DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus, keloids, localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques, necrobiosis lipoidica diabeticorum. DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia). DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
10	0	7

Other Developers

Total Other Developers	20

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
20MG/ML	**	**	-	-	-
40MG/ML	**	**	-	-	6
80MG/ML	**	**	-	-	5

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	6

Manufacturing Details of DEPO-MEDROL