Viewing data from:

TESTOSTERONE

ANDA

TESTOSTERONE | A208620 | ENCUBE ETHICALS PRIVATE LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ANDROGEL(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Unimed Pharmaceuticals LLC et al v. Dr.Reddy's Laboratories Ltd et al 1:2015cv01142 11 patentsANDA 208620testosterone gel	D. Del.	2015-12-10	Terminated 2016-02-11	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.4771

per gm

Lowest NADAC/Unit

$0.4771

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
21922003020TESTOSTERONE 1.62% GEL PUMP	$0.4771	GM	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain13 active DMFs12 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

PHARMACIA AND UPJOHN SUB PFIZER INCTESTOSTERONE, USP

DMF 31901978

ASPEN OSS BVTESTOSTERONE

DMF 118261996

BAYER AGTESTOSTERONE

DMF 150772000

BAYER AGTESTOSTERONE UNDECANOATE 750 MG I.M.

DMF 168092003

DR REDDYS LABORATORIES LTDTESTOSTERONE

DMF 236712010

SUN PHARMACEUTICAL INDUSTRIES LTDTESTOSTERONE USP

DMF 274472013

SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE USP (MICRONIZED)

DMF 298692015

LUPIN LTDTESTOSTERONE USP

DMF 303772016

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE CYPIONATE NON- STERILE, BULK DRUG SUBSTANCE

DMF 307412016

CURIA SPAIN SAUTESTOSTERONE MICRONIZED

DMF 328172018

HUBEI GOTO BIOTECHNOLOGY CO LTDTESTOSTERONE

DMF 331182018

HUBEI ZHUXI HUMANWELL PHARMACEUTICAL CO LTDTESTOSTERONE

DMF 370742022

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE TRIDECANOATE

DMF 378902023

F.X. GASSNER, COLORADO STATE UNIVERSITYInactiveTESTOSTERONE & DIETHYLSTILBESTROL-CATTLE FEED MIXED W/INGREDS--SAFETY?

DMF 2741940

DIOSYNTH BVInactiveTESTOSTERONE

DMF 39741980

ROUSSELL UCLAFInactiveTESTOSTERONE (DIOSYNTH BV)

DMF 45121982

SCHERING AGInactiveTESTOSTERONE

DMF 46951982

MEDISORB TECHNOLOGIES INTERNATIONAL LTD PARTNERSHIPInactiveTESTOSTERONE INJECTABLE MICROSPHERES

DMF 75021988

SIGMA F AND D DIV LTDInactiveTESTOSTERONE

DMF 99311992

ARDANA BIOSCIENCE LTDInactiveTESTOSTERONE CREAM 1% (ARD-0403)

DMF 193492006

CIPLA LTDInactiveTESTOSTERONE USP

DMF 215462008

BIOVET JOINT STOCK COInactiveTESTOSTERONE

DMF 231572009

PRODUCTOS QUIMICOS NATURALES SA DE CV PROQUINAInactiveTESTOSTERONE L-2

DMF 243102010

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDInactiveTESTOSTERONE PROPIONATE NON-STERILE BULK DRUG SUBSTANCE

DMF 256062011

INDO PHYTO CHEMICALS PRIVATE LTDInactiveTESTOSTERONE USP

DMF 264302012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Feb 21, 2019	ORIG -1	View Letter (PDF)
Oct 15, 2018	ORIG -1	View Letter (PDF)
Sep 14, 2018	ORIG -1	View Letter (PDF)
May 11, 2018	ORIG -1	View Letter (PDF)
Jan 8, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.62% (20.25MG/1.25GM ACTUATION)

0 patents0 exclusivities▴

GEL, METERED;TRANSDERMAL | Approved: Apr 10, 2019

No patent or exclusivity listings for this strength.