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TESTOSTERONE Drug Profile
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When do Testosterone patents expire, and what generic alternatives are available?
Testosterone is a drug marketed by Actavis Labs Ut Inc, Amneal Pharms Llc, Dr Reddys, Lupin Atlantis, Perrigo Israel, Twi Pharms, Ani Pharms Inc, Par Pharm, Perrigo Uk Finco, Watson Labs, Cipla, Lupin Ltd, Am Regent, Hikma Farmaceutica, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, West-ward Pharms Int, Wilshire Pharms Inc, Nexus Pharms, Bel Mar, Elkins Sinn, and Lilly. and is included in forty-nine NDAs.
The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-nine drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.
Summary for TESTOSTERONE
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Recent Clinical Trials for TESTOSTERONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aga Khan University | Phase 2 |
| ECOG-ACRIN Cancer Research Group | Phase 2 |
| Xiao X. Wei | Phase 2 |
Recent Litigation for TESTOSTERONE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ACRUX DDS PTY LTD. v. SANDOZ INC. | 2017-10-23 |
| Unimed Pharmaceuticals, LLC v. TWi Pharmaceuticals, Inc. | 2016-09-16 |
| Eli Lilly and Company v. Perrigo Company | 2016-08-24 |
Pharmacology for TESTOSTERONE
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for TESTOSTERONE
Synonyms for 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 |
| 1050678-68-6 |
| 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.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 |
| AC1L1LM0 |
| AKOS015894897 |
| AN-23597 |
| Andro 100 |
| Androderm |
| Androderm (TN) |
| Androderm, Delatestryl |
| AndroGel |
| Androgel (TN) |
| Androgel 1.62% |
| Androgel 1% |
| Androlin |
| Andronaq |
| Andronate 100 |
| Andronate 200 |
| Andropatch |
| Andropository 200 |
| Androsorb |
| 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 |
| Andryl 200 |
| Axiron |
| Axiron (TN) |
| B5DEE83F-632B-48A1-A0ED-A51E7F13DF2E |
| BC208298 |
| 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 |
| Everone 200 |
| 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 in Oil |
| Malogen, aquaspension injection |
| MCULE-1294118086 |
| Mertestate |
| MLS000563091 |
| MLS001032098 |
| MLS001306401 |
| MLS001424262 |
| MLS002174283 |
| mpp10 |
| MUMGGOZAMZWBJJ-DYKIIFRCSA-N |
| Nasobol |
| Natesto |
| NC00439 |
| NCGC00091018-01 |
| NCGC00258243-01 |
| Neo-Hombreol F |
| Neo-testis |
| Neotestis |
| NSC 9700 |
| Oreton |
| Oreton F |
| Oreton-F |
| Orquisteron |
| Perandren |
| Percutacrine androgenique |
| Primotest |
| Primoteston |
| Q-101251 |
| RB3046 |
| Relibra |
| RP29985 |
| S00309 |
| SC-15109 |
| Scheinpharm Testone-Cyp |
| SCHEMBL8452 |
| SMR000058344 |
| SMR001261453 |
| Striant |
| Striant (TN) |
| Sustanon |
| Sustanone |
| Sustason 250 |
| Synandrol F |
| T-Cypionate |
| Tefina |
| Teslen |
| Testamone 100 |
| Testandrone |
| Testaqua |
| Testiculosterone |
| Testim |
| Testim (TN) |
| Testobase |
| Testoderm |
| Testoderm Tts |
| Testogel |
| Testoject-50 |
| Testolin |
| Testopel Pellets |
| Testopropon |
| Testosteroid |
| Testosteron |
| Testosterona |
| Testosterona [INN-Spanish] |
| 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 and its esters |
| 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 |
| Testred Cypionate 200 |
| Testrin-P.A |
| Testro AQ |
| Testrone |
| Testryl |
| Tlando |
| Tox21_200689 |
| trans-Testosterone |
| UNII-3XMK78S47O |
| Virilon IM |
| Virormone |
| Virosterone |
| Vogelxo |
| W-5033 |
| ZINC118912393 |
Paragraph IV (Patent) Challenges for TESTOSTERONE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AXIRON | SOLUTION, METERED;TRANSDERMAL | testosterone | 022504 | 2013-01-29 |
| FORTESTA | GEL, METERED;TRANSDERMAL | testosterone | 021463 | 2012-08-14 |
| TESTIM | GEL;TRANSDERMAL | testosterone | 021454 | 2008-08-21 |
US Patents and Regulatory Information for TESTOSTERONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Pharms Inc | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 086030-001 | Approved Prior to Jan 1, 1982 | AO | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Institutional | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 040652-001 | Dec 11, 2006 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Watson Labs | TESTOSTERONE ENANTHATE | testosterone enanthate | INJECTABLE;INJECTION | 083667-001 | 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 |
