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Last Updated: December 14, 2019

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METHYLTESTOSTERONE Drug Profile

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When do Methyltestosterone patents expire, and what generic alternatives are available?

Methyltestosterone is a drug marketed by Heather, Impax Labs Inc, Impax Labs, Lilly, Purepac Pharm, Pvt Form, Tablicaps, Usl Pharma, Inwood Labs, Kv Pharm, Lannett, Parke Davis, Watson Labs, and West Ward. and is included in twenty-seven NDAs.

The generic ingredient in METHYLTESTOSTERONE is methyltestosterone. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methyltestosterone profile page.

US ANDA Litigation and Generic Entry Outlook for Methyltestosterone

A generic version of METHYLTESTOSTERONE was launched as methyltestosterone by IMPAX LABS on December 14th, 2019.

Drug patent expirations by year for METHYLTESTOSTERONE
Recent Clinical Trials for METHYLTESTOSTERONE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4
Solvay PharmaceuticalsPhase 2

See all METHYLTESTOSTERONE clinical trials

Pharmacology for METHYLTESTOSTERONE
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for METHYLTESTOSTERONE
Synonyms for METHYLTESTOSTERONE
(17-beta)-17-Hydroxy-17-methylandrost-4-en-3-one
(17beta)-17-hydroxy-17-methylandrost-4-en-3-one
(1S,2R,10R,11S,14S,15S)-14-hydroxy-2,14,15-trimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-5-one
(1S,2R,10R,11S,14S,15S)-14-hydroxy-2,14,15-trimethyltetracyclo[8.7.0.0(2),.0(1)(1),(1)]heptadec-6-en-5-one
(8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13,17-trimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one
(8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13,17-trimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one
1050679-28-1
1300-17-0
17 beta-Hydroxy-17-methyl-4-androsten-3-one
17 beta-Methyltestosterone
17-.beta.-Hydroxy-17-methylandrost-4-en-3-one
17-alpha-Methyltestosterone
17-alpha-Methyltestosterone 100 microg/mL in Acetonitrile
17-beta-Hydroxy-17-methylandrost-4-en-3-one
17-Epimethyltestosterone
17-Hydroxy-17-methyl-3-keto-androstene-4
17-Hydroxy-17-methylandrost-4-en-3-one #
17-Methyltestoster
17-Methyltestosteron
17-Methyltestosterone
17-MT
17.alpha.-methyl-.DELTA.4-androsten-17.beta.-ol-3-one
17.alpha.-Methyl-3-oxo-4-androsten-17.beta.-ol
17.alpha.-Methyltestosterone
17.beta.-Hydroxy-17.alpha.-methylandrost-4-en-3-one
17(alpha)-methyl-Delta(4)-androsten-17(beta)-ol-3-one
17(alpha)-Methyl-delta4-androsten-17(beta)-ol-3-one
17|A-Methyltestosterone
17alpha-Methyl-3-oxo-4-androsten-17beta-ol
17alpha-Methyl-delta-androsten-17beta-ol-3-one
17alpha-methyl-Delta(4)-androsten-17beta-ol-3-one
17alpha-methyl-Delta4-androsten-17beta-ol-3-one
17alpha-Methyltestosterone
17alpha-Methyltestosterone solution, 1.0 mg/mL in 1,2-dimethoxyethane, ampule of 1 mL, certified reference material
17alpha-Methyltestosterone, >=97.0% (HPLC)
17alpha-Methyltestosterone, solid (photosensitive)
17alpha-Methyltestosterone, VETRANAL(TM), analytical standard
17beta-Hydroxy-17-methyl-4-androsten-3-one
17beta-Hydroxy-17-methylandrost-4-en-3-one
17beta-Methyltestosterone
262423-02-9
31745-24-1
4-08-00-01010 (Beilstein Handbook Reference)
4-Androstene-17-alpha-methyl-17-beta-ol-3-one
4-Androstene-17.alpha.-methyl-17.beta.-ol-3-one
4-Androstene-17alpha-methyl-17beta-ol-3-one
58-18-4
AB00443683-06
AB00443683-09
AC1L1LLR
ACN-031982
AKOS015917317
AN-41744
Android
Android (TN)
Android 10
Android 25
Android 5
Android-10
Android-25
Android-5
Andrometh
Androsan
Androsan (tablets)
Androsan (VAN)
Androsan, tablets
Androst-4-en-3-on-17.beta.-ol, 17.alpha.-methyl
Androst-4-en-3-one, 17-beta-hydroxy-17-methyl-
Androst-4-en-3-one, 17-hydroxy-17-methyl-, (17b)-
Androst-4-en-3-one, 17-hydroxy-17-methyl-, (17beta)-
Androst-4-en-3-one, 17.beta.-hydroxy-17-methyl-
Androst-4-en-3-one, 17beta-hydroxy-17-methyl-
Androst-4-ene-17.alpha.-methyl-17.beta.-ol-3-one
Androsten
Anertan
Anertan (tablets)
Anertan (VAN)
Anertan, tablets
API0003346
BDBM50410531
BRN 2057425
C07198
CAS-58-18-4
CCG-100871
CCRIS 3723
CDB 110
CHEBI:27436
CHEMBL1395
CJ-10774
component of Estan
component of Gynetone
component of Gynetone (Salt/Mix)
component of Tylosterone
Conjugated estrogens / methyltestosterone
Conjugated estrogens mixture with methyltestosterone
CS-5099
D00408
DB06710
DSSTox_CID_13664
DSSTox_GSID_33664
DSSTox_RID_79089
DTXSID1033664
Dumogran
EINECS 200-366-3
Estan (Salt/Mix)
Estratest
Estratest (Salt/Mix)
Estratest H.S.
Estratest HS
Estratest-HS
GCKMFJBGXUYNAG-HLXURNFRSA-N
Glosso sterandryl
Glosso-sterandryl
GS-6594
GTPL6945
HMS2051A14
HMS2272A06
Homandren
Homandren (VAN)
Homandren, tablets
Hormale
HSDB 3365
HY-A0121
I14-9703
KB-64817
L 589.372
LMST02020029
LS-19506
M.T.Mucorettes
M0435
Malestrone
Malogen
Masenone
Mastestona
MCULE-5274452426
Mesteron
Mesterone
Metandren
Metestone
Methitest
METHYL TESTOSTERONE
Methyltestosterone (17alpha-Methyltestosterone)
Methyltestosterone (17alpha-Methyltestosterone) 1.0 mg/ml in Acetonitrile
Methyltestosterone (JP17/USP/INN)
Methyltestosterone [USAN:INN:BAN:JAN]
Methyltestosterone [USP:INN:BAN:JAN]
Methyltestosterone for system suitability, European Pharmacopoeia (EP) Reference Standard
Methyltestosterone mixture with conjugated estrogens
Methyltestosterone, European Pharmacopoeia (EP) Reference Standard
Methyltestosterone, United States Pharmacopeia (USP) Reference Standard
Methyltestosteronum
Methyltestosteronum [INN-Latin]
Metiltestosterona
Metiltestosterona [INN-Spanish]
Metiltestosterone
Metiltestosterone [DCIT]
Metrone
MLS000759474
MLS001424040
MLS002174282
MolPort-003-933-840
Nabolin
NC00121
NCGC00091009-01
NCGC00091009-03
NCGC00091009-04
NCGC00091009-05
NCGC00091009-06
NCGC00091009-07
Neo-Hombreol [M]
Neo-Hombreol-M
Neo-Homobreol (M)
Neo-Homobreol [M]
NSC 139965
NSC-139965
NSC-9701
NSC139965
NSC9701
Nu-man
Oraviron
Orchisterone-M
Oreton M
Oreton Methyl
Oreton-M
Oretron
Premarin with methyltestosterone
Premarin with Methyltestosterone (Salt/Mix)
RU 24400
SC-16208
SCHEMBL18657
SMR000058528
SMR001261452
Steronyl
Synandrets
Synandrotabs
Syndren
Testhormone
Testora
Testosterone, 17-methyl-
Testoviron (tablet)
Testoviron (VAN)
Testovis (tablet)
Testovis Depot
Testred
Testred (TN)
TL8003728
Tox21_113161
Tox21_113162
Tox21_113162_1
Tox21_400058
U 2842
UNII-V9EFU16ZIF
V9EFU16ZIF
Virilon
WLN: L E5 B666 OV MUTJ A E FQ F -B&AEF
ZINC3814422

US Patents and Regulatory Information for METHYLTESTOSTERONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West Ward METHYLTESTOSTERONE methyltestosterone TABLET;ORAL 084331-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Tablicaps METHYLTESTOSTERONE methyltestosterone TABLET;ORAL 085270-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
West Ward METHYLTESTOSTERONE methyltestosterone TABLET;ORAL 084642-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs METHYLTESTOSTERONE methyltestosterone TABLET;ORAL 080933-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Heather METHYLTESTOSTERONE methyltestosterone CAPSULE;ORAL 084967-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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