FLUDROCORTISONE ACETATE Drug Patent Profile
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When do Fludrocortisone Acetate patents expire, and what generic alternatives are available?
Fludrocortisone Acetate is a drug marketed by Barr, Hikma, Hikma Pharms, Impax Labs, and Novitium Pharma. and is included in five NDAs.
The generic ingredient in FLUDROCORTISONE ACETATE is fludrocortisone acetate. There are four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the fludrocortisone acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fludrocortisone Acetate
A generic version of FLUDROCORTISONE ACETATE was approved as fludrocortisone acetate by IMPAX LABS on March 18th, 2002.
Summary for FLUDROCORTISONE ACETATE
Recent Clinical Trials for FLUDROCORTISONE ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Michigan | Phase 2 |
| Children's Hospital Los Angeles | Phase 2 |
| National Institutes of Health Clinical Center (CC) | Phase 2 |
Medical Subject Heading (MeSH) Categories for FLUDROCORTISONE ACETATE
Anatomical Therapeutic Chemical (ATC) Classes for FLUDROCORTISONE ACETATE
US Patents and Regulatory Information for FLUDROCORTISONE ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Barr | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 040425-001 | Jan 21, 2003 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Impax Labs | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 040431-001 | Mar 18, 2002 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 216013-001 | Oct 27, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma Pharms | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 091302-001 | Jul 22, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
