Sold as Oreton Methyl, Metandren. Every FDA application for this active ingredient: 2 branded and 34 generic.
As of Nov 13, 2026, FDA lists 36 applications for Methyltestosterone (sold as Oreton Methyl, Metandren), with 0 new uses approved and 0 published complete response letters.
| Methyltestosterone | Part D | $296K | -4% | 21 |
| Methitest | Part D | $156K | -56% | 11 |
| Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With HypogonadismMale Hypogonadism · Amneal Pharmaceuticals, LLC | Phase 3 | Recruiting | Oct 27, 2026 |
| Testing the Use of High Dose Testosterone Followed by Darolutamide Compared to the Usual Care for Patients With Metastatic Prostate CancerMetastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 · ECOG-ACRIN Cancer Research Group | Phase 2 / Phase 3 | Not yet recruiting | Oct 1, 2026 |
| Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI TrialSpinal Cord Injury, Spinal Cord Injuries · VA Office of Research and Development | Phase 2 / Phase 3 | Not yet recruiting | Aug 3, 2026 |
| Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite AthletesSafety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes · Enhanced Emirates Limited | Not applicable | Enrolling by invitation | May 6, 2026 |
| Effect of Testosterone on Elderly Frail Men With Testosterone DeficiencyFrail Elderly Patients, Hypogonadal Males · Rune Skovgaard Rasmussen | Phase 2 | Not yet recruiting | Apr 6, 2026 |
| Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPCMetastatic Castration-resistant Prostate Cancer · H. Lee Moffitt Cancer Center and Research Institute | Phase 2 | Recruiting | Mar 17, 2026 |
| Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal MenHypogonadism, Male · Azurity Pharmaceuticals | Phase 4 | Not yet recruiting | Jan 9, 2026 |
| Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active SurveillanceProstate Cancer, Hypogonadism, Male · University of Miami | Phase 4 | Recruiting | Dec 12, 2025 |
| Dec 22, 1971 | MethyltestosteroneANDA 80256 | Lilly | 0 | Discontinued |
| Jul 24, 1972 | MethyltestosteroneANDA 80839 | Inwood Labs | 0 | Discontinued |
| Sep 15, 1972 | MethyltestosteroneANDA 80973 | Inwood Labs | 0 | Discontinued |
| Dec 3, 1973 | TestredANDA 83976 | Bausch | 13 | Discontinued |
| Jun 21, 1974 | MethyltestosteroneANDA 84310 | Impax Labs | 16 | Discontinued |
| Jul 16, 1974 | MethyltestosteroneANDA 84287 | Impax Labs | 9 | Discontinued |
| Oct 17, 1974 | MethyltestosteroneANDA 80767 | Impax Labs | 16 | Marketed |
| Oct 8, 1976 | MethyltestosteroneANDA 84312 | Kv Pharm | 3 | Discontinued |
| Feb 2, 1977 | MethyltestosteroneANDA 85125 | Tablicaps | 0 | Discontinued |
| Aug 3, 1979 | OretonANDA 80281 | Schering | 3 | Discontinued |
| Feb 9, 1981 | Android 10ANDA 86450 | Valeant Pharms North | 13 | Discontinued |
| Feb 9, 1981 | Android 5ANDA 87222 | Valeant Pharm Intl | 1 | Discontinued |
| Feb 9, 1981 | Android 25ANDA 87147 | Bausch | 13 | Discontinued |
| Nov 5, 1982 | MethyltestosteroneANDA 87092 | Lannett | 5 | Discontinued |
| Nov 24, 1982 | VirilonANDA 87750 | Chartwell | 10 | Discontinued |
| Jan 27, 1983 | MethyltestosteroneANDA 87111 | Lannett | 5 | Discontinued |
| Jun 28, 1993 | MethyltestosteroneANDA 80271 | Usl Pharma | 0 | Discontinued |
| Sep 21, 2015 | MethyltestosteroneANDA 204851 | Impax Labs Inc | 2 | Marketed |
| Feb 18, 2022 | MethyltestosteroneANDA 215270 | Novitium Pharma | 1 | Marketed |
| — | Oreton MethylNDA 3158 | Schering | 0 | Discontinued |
| — | MetandrenNDA 3240 | Novartis | 0 | Discontinued |
| — | MethyltestosteroneANDA 84967 | Heather | 0 | Discontinued |
| — | MethyltestosteroneANDA 80214 | Pvt Form | 0 | Discontinued |
| — | MethyltestosteroneANDA 80308 | Purepac Pharm | 0 | Discontinued |
| — | MethyltestosteroneANDA 80309 | Purepac Pharm | 0 | Discontinued |
| — | MethyltestosteroneANDA 80310 | Purepac Pharm | 0 | Discontinued |
| — | MethyltestosteroneANDA 80313 | Tablicaps | 0 | Discontinued |
| — | MethyltestosteroneANDA 80475 | Purepac Pharm | 0 | Discontinued |
| — | MethyltestosteroneANDA 80931 | Watson Labs | 0 | Discontinued |
| — | MethyltestosteroneANDA 80933 | Watson Labs | 0 | Discontinued |
| — | MethyltestosteroneANDA 83836 | Pvt Form | 0 | Discontinued |
| — | MethyltestosteroneANDA 84241 | Parke Davis | 0 | Discontinued |
| — | MethyltestosteroneANDA 84244 | Parke Davis | 0 | Discontinued |
| — | MethyltestosteroneANDA 84331 | West Ward | 0 | Discontinued |
| — | MethyltestosteroneANDA 84642 | West Ward | 0 | Discontinued |
| — | MethyltestosteroneANDA 85270 | Tablicaps | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Lilly
Impax Labs
Schering
Novitium Pharma
Novartis
Parke Davis