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Details for New Drug Application (NDA): 011366
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NDA 011366 describes KEVEYIS, which is a drug marketed by Strongbridge Us and is included in one NDA. It is available from two suppliers. Additional details are available on the KEVEYIS profile page.
The generic ingredient in KEVEYIS is dichlorphenamide. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dichlorphenamide profile page.
The generic ingredient in KEVEYIS is dichlorphenamide. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dichlorphenamide profile page.
Summary for 011366
| Tradename: | KEVEYIS |
| Applicant: | Strongbridge Us |
| Ingredient: | dichlorphenamide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 011366
Generic Entry Date for 011366*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PRIMARY HYPERKALEMIC PERIODIC PARALYSIS, PRIMARY HYPOKALEMIC PERIOD PARALYSIS, AND RELATED VARIANTS Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 011366
| Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 011366
Suppliers and Packaging for NDA: 011366
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DARANIDE | dichlorphenamide | TABLET;ORAL | 011366 | NDA | Taro Pharmaceuticals U.S.A., inc. | 51672-4177 | 51672-4177-1 | 100 TABLET in 1 BOTTLE (51672-4177-1) |
| DARANIDE | dichlorphenamide | TABLET;ORAL | 011366 | NDA | Strongbridge US Inc. | 71090-001 | 71090-001-01 | 100 TABLET in 1 BOTTLE (71090-001-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 7, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 7, 2022 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PRIMARY HYPERKALEMIC PERIODIC PARALYSIS, PRIMARY HYPOKALEMIC PERIOD PARALYSIS, AND RELATED VARIANTS | ||||||||
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