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, Chartwell Rx, 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. Twelve 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: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 63 |
| Clinical Trials: | 10 |
| Patent Applications: | 6,210 |
| 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 |
|---|---|
| Orion Corporation, Orion Pharma | Phase 3 |
| Merck Sharp & Dohme LLC | Phase 3 |
| Merck Sharp & Dohme LLC | Phase 1 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma Pharms | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 091302-001 | Jul 22, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novitium Pharma | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 215279-001 | May 31, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Barr | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 040425-001 | Jan 21, 2003 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 216013-001 | Oct 27, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Casper Pharma Llc | FLORINEF | fludrocortisone acetate | TABLET;ORAL | 010060-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax Labs | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 040431-001 | Mar 18, 2002 | AB | RX | No | Yes | ⤷ 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 |
