Fludrocortisone acetate - Generic Drug Details
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What are the generic sources for fludrocortisone acetate and what is the scope of freedom to operate?
Fludrocortisone acetate
is the generic ingredient in two branded drugs marketed by Casper Pharma Llc, Barr, Hikma, Hikma Pharms, Impax Labs, and Novitium Pharma, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for fludrocortisone acetate. Eleven suppliers are listed for this compound.
Summary for fludrocortisone acetate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 6 |
| NDAs: | 6 |
| Drug Master File Entries: | 4 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 63 |
| Clinical Trials: | 6 |
| Patent Applications: | 6,144 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for fludrocortisone acetate |
| What excipients (inactive ingredients) are in fludrocortisone acetate? | fludrocortisone acetate excipients list |
| DailyMed Link: | fludrocortisone acetate at DailyMed |
Recent Clinical Trials for fludrocortisone acetate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Hospital Los Angeles | Phase 2 |
| National Institutes of Health Clinical Center (CC) | Phase 2 |
| University of Texas Southwestern Medical Center | Phase 2 |
Medical Subject Heading (MeSH) Categories 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| Casper Pharma Llc | FLORINEF | fludrocortisone acetate | TABLET;ORAL | 010060-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ 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 |
