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Last Updated: April 6, 2020

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NATESTO Drug Profile


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Which patents cover Natesto, and what generic alternatives are available?

Natesto is a drug marketed by Acerus and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-seven patent family members in twenty-one countries.

The generic ingredient in NATESTO is testosterone. There are sixty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.

US ANDA Litigation and Generic Entry Outlook for Natesto

A generic version of NATESTO was approved as testosterone by ACTAVIS LABS UT INC on January 27th, 2006.

  Start Trial

Drug patent expirations by year for NATESTO
Drug Prices for NATESTO

See drug prices for NATESTO

Recent Clinical Trials for NATESTO

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

SponsorPhase
University of MiamiPhase 4
Acerus Pharmaceuticals CorporationPhase 4
Partnership for Clean CompetitionPhase 4

See all NATESTO clinical trials

Pharmacology for NATESTO
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Synonyms for NATESTO
(+)-testosterone
(17?)-17-Hydroxyandrost-4-en-3-one
(17beta)-17-Hydroxyandrost-4-en-3-one
(1S,2R,10R,11S,14S,15S)-14-hydroxy-2,15-dimethyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadec-6-en-5-one
(8alpha,10alpha,13alpha,14beta,17alpha)-17-hydroxyandrost-4-en-3-one
(8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-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-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one
(8R,9S,10R,13S,14S,17S)-17-Hydroxy-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one
003T654
17-.beta.-Hydroxyandrost-4-en-3-one
17-beta-Hydroxy-delta(sup 4)-androsten-3-one
17-beta-Hydroxyandrost-4-en-3-one
17-Hydroxy-(17-beta)-androst-4-en-3-one
17-Hydroxy-(17beta)-androst-4-en-3-one
17-Hydroxyandrost-4-en-3-one, (17.beta.)-
17?-hydroxyandrost-4-en-3-one; epitestosterone; 17-epi-Testosterone; 17?-cis-Testosterone; 4-Androstene-17?-ol-3-one; Isotestosterone
17.beta.-Hydroxy-.DELTA.4-androsten-3-one
17.beta.-Testosterone
17b-hydroxy-4-androsten-3-one
17beta-Hydroxy-4-androsten-3-one
17beta-hydroxy-4-androsten-3one
17beta-Hydroxy-delta(sup4)-androsten-3-one
17beta-Hydroxyandrost-4-en-3-one
17beta-Hydroxyandrost-4-ene-3-one
1i37
3kdm
3XMK78S47O
4-Androsten-17.beta.-ol-3-one
4-Androsten-17beta-ol-3-one
4-Androsten-3-one-17.beta.-ol
4-Androsten-3-one, 17b-hydroxy-
4-androstene-17beta-ol-3-one
58-22-0
7-beta-Hydroxyandrost-4-en-3-one
AA 2500
AB00973630-03
AC-14899
AKOS015894897
Andro 100
Androderm
Androderm (TN)
AndroGel
Androgel (TN)
Androgel 1.62%
Androgel 1%
Androlin
Andronaq
Andropatch
Androst-4-en-17beta-ol-3-one
Androst-4-en-3-on-17B-ol
Androst-4-en-3-one, 17-beta-hydroxy-
Androst-4-en-3-one, 17-hydroxy-, (17-beta)-
Androst-4-en-3-one, 17-hydroxy-, (17.beta.)-
Androst-4-en-3-one, 17-hydroxy-, (17b)-
Androst-4-en-3-one, 17-hydroxy-, (17beta)-
Androst-4-en-3-one, 17-hydroxy, (17.beta.)-
Androst-4-en-3-one, 17beta-hydroxy-
Andrusol
Axiron
Axiron (TN)
B5DEE83F-632B-48A1-A0ED-A51E7F13DF2E
BDBM8885
beta testosterone
BIDD:ER0555
BIM-0061761.0001
Bio-T-Gel
C-18145
C00535
CAS-58-22-0
CCG-101189
CCRIS 574
CDB 111C
CHEBI:17347
CHEMBL386630
CMC_13449
COL 1621
CompleoTRT
component of Di-Genik (Salt/Mix)
component of Di-Met (Salt/Mix)
component of Duogen (Salt/Mix)
component of Intrinsa (Salt/Mix)
component of Mal-O-Fem (Salt/Mix)
component of Tostrex (Salt/Mix)
CP 601B
CPD000058344
Cristerona T
Cristerone T
CS-1415
D00075
DB00624
delta(sup 4)-Androsten-17(beta)-ol-3-one
delta4-androsten-17b-ol-3-one
delta4-Androsten-17beta-ol-3-one
DSSTox_CID_2371
DSSTox_GSID_22371
DSSTox_RID_76563
DTXSID8022371
EC 200-370-5
EINECS 200-370-5
Epitope ID:135865
Fortesta
Geno-cristaux gremy
GTPL2858
Halotensin
HMS2052N11
HMS2272B03
HMS2272P03
Homosteron
Homosterone
HSDB 3398
HY-15554A
Intrinsa
LibiGel
LMST02020002
LPCN 1021
LS-148813
Malerone
Malestrone (amps)
Malogen, aquaspension injection
MCULE-1294118086
Mertestate
MLS000563091
MLS001032098
MLS001306401
MLS001424262
MLS002174283
mpp10
MUMGGOZAMZWBJJ-DYKIIFRCSA-N
Nasobol
NC00439
NCGC00091018-01
NCGC00258243-01
Neo-Hombreol F
Neo-testis
Neotestis
NSC 9700
NSC-9700
Oreton
Oreton-F
Orquisteron
Perandren
Percutacrine androgenique
Primotest
Primoteston
Q-101251
Q1318776
RB3046
Relibra
S00309
SC-15109
SCHEMBL8452
SMR000058344
SMR001261453
Striant
Striant (TN)
Sustanon
Sustanone
Sustason 250
Synandrol F
Tefina
Teslen
Testandrone
Testex
Testiculosterone
Testim
Testim (TN)
Testobase
Testoderm
Testoderm Tts
Testogel
Testoject-50
Testolin
Testopel Pellets
Testopropon
Testosteroid
Testosteron
Testosterona
Testosterona [INN-Spanish]
testosterone
Testosterone (JAN/USP)
Testosterone [Androgenic steroids, anabolic]
Testosterone [INN:BAN]
Testosterone [USP:INN:BAN]
Testosterone 1.0 mg/ml in Acetonitrile
Testosterone 100 microg/mL in Acetonitrile
Testosterone 100 microg/mL in Methanol
Testosterone and its esters
Testosterone ciii
Testosterone EP Impurity C
Testosterone for impurity D identification, European Pharmacopoeia (EP) Reference Standard
Testosterone for system suitability, European Pharmacopoeia (EP) Reference Standard
Testosterone hydrate
Testosterone solution, 1.0 mg/mL in 1,2-dimethoxyethane, drug standard
Testosterone solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material
Testosterone, >=98%
Testosterone, 1
Testosterone, cell culture tested
Testosterone, European Pharmacopoeia (EP) Reference Standard
Testosterone, purum, >=99.0% (HPLC)
Testosterone, VETRANAL(TM), analytical standard
Testosterone; 4-Androsten-17?-ol-3-one; 17?-Hydroxy-4-androsten-3-one
Testosteronum
Testosteronum [INN-Latin]
Testostosterone
Testoviron
Testoviron Schering
Testoviron T
Testro AQ
Testrone
Testryl
Tlando
Tox21_200689
trans-Testosterone
UNII-3XMK78S47O
Virormone
Virosterone
Vogelxo
W-5033
ZINC118912393

US Patents and Regulatory Information for NATESTO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acerus NATESTO testosterone GEL, METERED;NASAL 205488-001 May 28, 2014 RX No No   Start Trial   Start Trial Y   Start Trial
Acerus NATESTO testosterone GEL, METERED;NASAL 205488-001 May 28, 2014 RX No No   Start Trial   Start Trial Y   Start Trial
Acerus NATESTO testosterone GEL, METERED;NASAL 205488-001 May 28, 2014 RX No No   Start Trial   Start Trial   Start Trial
Acerus NATESTO testosterone GEL, METERED;NASAL 205488-001 May 28, 2014 RX No No   Start Trial   Start Trial Y   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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Colorcon
McKinsey
Medtronic
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.