
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| EPRONTIA | Azurity | N-214679 RX | 2021-11-05 | 1 products, RLD, RS |
| TOPAMAX | Johnson & Johnson | N-020505 RX | 1996-12-24 | 4 products, RLD |
| TOPAMAX | Johnson & Johnson | N-020844 RX | 1998-10-26 | 2 products, RLD, RS |
| TROKENDI XR | Supernus Pharmaceuticals | N-201635 RX | 2013-08-16 | 4 products, RLD, RS |
| QUDEXY XR | Upsher-Smith Laboratories | N-205122 RX | 2014-03-11 | 5 products, RLD, RS |
Brand Name | Status | Last Update |
|---|---|---|
| eprontia | New Drug Application | 2025-03-21 |
| phentermine and topiramate | ANDA | 2025-06-24 |
| phentermine and topiramate extended-release | ANDA | 2025-05-21 |
| qsymia | New Drug Application | 2025-09-08 |
| qudexy | New Drug Application | 2025-02-07 |
| qudexy qudexy | New Drug Application | 2025-03-03 |
| qudexy qudexy | New Drug Application | 2025-04-10 |
| topamax | New Drug Application | 2025-03-24 |
| topiramate | ANDA | 2025-10-01 |
| topiramate tablets | 2009-04-03 |
Expiration | Code | ||
|---|---|---|---|
PHENTERMINE HYDROCHLORIDE / TOPIRAMATE, QSYMIA, VIVUS | |||
| 2025-06-24 | NPP | ||
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Topiramate, Eprontia, Azurity | |||
| 11433046 | 2040-08-21 | U-3413, U-3414, U-3415 | |
| 11633374 | 2040-08-21 | DP | |
| Topiramate, Qudexy Xr, Upsher Smith Labs | |||
| 8652527 | 2033-03-19 | DP | |
| 8889190 | 2033-03-19 | DP | |
| 9101545 | 2033-03-19 | DP | |
| 9555005 | 2033-03-19 | DP | |
| 10363224 | 2033-03-19 | U-766 | |
| Phentermine Hydrochloride / Topiramate, Qsymia, Vivus | |||
| 8580299 | 2029-06-14 | U-3399 | |
| 8580298 | 2029-05-15 | DP | |
| 8895057 | 2028-06-09 | U-3398 | |
| 8895058 | 2028-06-09 | DP | |
| 9011905 | 2028-06-09 | DP | |
| 9011906 | 2028-06-09 | U-3398 | |
| Topiramate, Trokendi Xr, Supernus Pharms | |||
| 8298576 | 2028-04-04 | DP | U-106, U-1992 |
| 8298580 | 2027-11-16 | DP | U-106, U-1992 |
| 8663683 | 2027-11-16 | DP | U-106, U-1992 |
| 8877248 | 2027-11-16 | DP | U-106, U-1992 |
| 8889191 | 2027-11-16 | U-106, U-1992 | |
| 8992989 | 2027-11-16 | DP | U-1675, U-1992 |
| 9549940 | 2027-11-16 | DP | U-1675, U-1992 |
| 9555004 | 2027-11-16 | DP | U-1675, U-1992 |
| 9622983 | 2027-11-16 | DP | U-1675, U-1992 |
| 10314790 | 2027-11-16 | DP | U-1675, U-1992 |

Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | 5 | 7 | 20 | 18 | 16 | 65 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 3 | 14 | 17 | 18 | 8 | 59 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 8 | 9 | 16 | 14 | 13 | 57 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 2 | 14 | 8 | 8 | 2 | 30 |
| Seizures | D012640 | — | G40.4 | 1 | 5 | 15 | 3 | 3 | 27 |
| Headache | D006261 | — | R51 | — | 2 | 7 | 5 | 5 | 19 |
| Weight loss | D015431 | — | — | 2 | 3 | 2 | 5 | 2 | 14 |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | 5 | 5 | 4 | — | 14 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 2 | — | 5 | 6 | — | 13 |
| Syndrome | D013577 | — | — | — | 1 | 6 | 2 | 3 | 12 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | — | F14 | 1 | 5 | 3 | — | 1 | 9 |
| Feeding and eating disorders | D001068 | — | F50 | 2 | 2 | 2 | — | 2 | 7 |
| Binge-eating disorder | D056912 | — | F50.2 | 1 | 3 | 2 | — | 2 | 7 |
| Tobacco use disorder | D014029 | — | F17 | — | 3 | 2 | — | — | 4 |
| Gambling | D005715 | EFO_1001926 | F63.0 | — | 2 | 1 | — | — | 3 |
| Lennox gastaut syndrome | D065768 | — | G40.81 | — | — | 2 | — | 1 | 3 |
| Spasm | D013035 | — | M62.83 | — | 1 | 1 | — | 1 | 2 |
| Prader-willi syndrome | D011218 | Orphanet_739 | Q87.11 | — | — | 1 | — | 1 | 2 |
| Tonic-clonic epilepsy | D004830 | EFO_0007262 | — | 1 | — | 1 | — | — | 2 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | — | 2 | — | — | 2 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 11 | 1 | — | — | 2 | 14 |
| Addictive behavior | D016739 | EFO_0004347 | — | 1 | 1 | — | — | 2 | 4 |
| Alcoholic intoxication | D000435 | — | — | — | 3 | — | — | — | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 2 | — | — | — | 2 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 2 | — | — | — | 2 |
| Gliosarcoma | D018316 | — | — | 1 | 2 | — | — | — | 2 |
| Dyskinesias | D020820 | — | G24 | — | 2 | — | — | — | 2 |
| Bariatric surgery | D050110 | — | — | — | 2 | — | — | — | 2 |
| Ischemia | D007511 | EFO_0000556 | — | 1 | 2 | — | — | — | 2 |
| Hypoxia | D000860 | — | R09.02 | 1 | 2 | — | — | — | 2 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | 1 | 3 |
| Torsades de pointes | D016171 | EFO_0005307 | I47.21 | 1 | — | — | — | — | 1 |
| Postoperative pain | D010149 | — | G89.18 | 1 | — | — | — | — | 1 |
| Congenital heart defects | D006330 | — | Q24.9 | 1 | — | — | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acidosis | D000138 | EFO_1000014 | E87.2 | — | — | — | — | 2 | 2 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 1 | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | — | — | — | 1 | 1 |
| Synovitis | D013585 | EFO_0008997 | M67.5 | — | — | — | — | 1 | 1 |
| Radiculopathy | D011843 | — | M54.1 | — | — | — | — | 1 | 1 |
| Gout | D006073 | EFO_0004274 | M10 | — | — | — | — | 1 | 1 |
| Rett syndrome | D015518 | Orphanet_778 | F84.2 | — | — | — | — | 1 | 1 |
| Financial stress | D000086522 | — | — | — | — | — | — | 1 | 1 |
| Metabolic bone diseases | D001851 | — | — | — | — | — | — | 1 | 1 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | — | — | 1 | 1 |
| Drug common name | Topiramate |
| INN | topiramate |
| Description | Topiramate is a hexose derivative that is 2,3:4,5-di-O-isopropylidene-beta-D-fructopyranose in which the hydroxy group has been converted to the corresponding sulfamate ester. It blocks voltage-dependent sodium channels and is used as an antiepileptic and for the prevention of migraine. It has a role as an anticonvulsant and a sodium channel blocker. It is a cyclic ketal, a sulfamate ester and a ketohexose derivative. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | ![]() |
| Structure (InChI/SMILES or Protein Sequence) | CC1(C)O[C@@H]2CO[C@@]3(COS(N)(=O)=O)OC(C)(C)O[C@H]3[C@@H]2O1 |
| PDB | — |
| CAS-ID | 97240-79-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL220492 |
| ChEBI ID | 63631 |
| PubChem CID | 5284627 |
| DrugBank | DB00273 |
| UNII ID | 0H73WJJ391 (ChemIDplus, GSRS) |










