ANDROGEL (nda021015)- (12.5MG/1.25GM ACTUATION)

Generic Name	TESTOSTERONE	Innovator	BESINS HLTHCARE
Dosage	12.5MG/1.25GM ACTUATION
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2021-Mar-02	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	AndroGel™ is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: 1. Primary hypogonadism (congenital or acquired) – testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range. 2. Hypogonadotropic hypogonadism (congenital or acquired)--idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	1

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
12.5MG/1.25GM ACTUATION	**	**	-	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of ANDROGEL