DICLOXACILLIN SODIUM Drug Patent Profile
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Which patents cover Dicloxacillin Sodium, and when can generic versions of Dicloxacillin Sodium launch?
Dicloxacillin Sodium is a drug marketed by Aurobindo Pharma, Chartwell Rx, Teva, and Apothecon. and is included in four NDAs.
The generic ingredient in DICLOXACILLIN SODIUM is dicloxacillin sodium. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dicloxacillin sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dicloxacillin Sodium
A generic version of DICLOXACILLIN SODIUM was approved as dicloxacillin sodium by TEVA on June 3rd, 1982.
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Summary for DICLOXACILLIN SODIUM
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 90 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,085 |
| DailyMed Link: | DICLOXACILLIN SODIUM at DailyMed |
Recent Clinical Trials for DICLOXACILLIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Pharmacology for DICLOXACILLIN SODIUM
| Drug Class | Penicillin-class Antibacterial |
Medical Subject Heading (MeSH) Categories for DICLOXACILLIN SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for DICLOXACILLIN SODIUM
US Patents and Regulatory Information for DICLOXACILLIN SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 216845-001 | Sep 23, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva | DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 062286-002 | Jun 3, 1982 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 061454-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apothecon | DICLOXACILLIN SODIUM | dicloxacillin sodium | FOR SUSPENSION;ORAL | 061455-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma | DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 216845-002 | Sep 23, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 061454-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 062286-001 | Jun 3, 1982 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
