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, Chartwell Rx, 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. Twelve 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.
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Questions you can ask:
- What is the 5 year forecast for FLUDROCORTISONE ACETATE?
- What are the global sales for FLUDROCORTISONE ACETATE?
- What is Average Wholesale Price for FLUDROCORTISONE ACETATE?
Summary for FLUDROCORTISONE ACETATE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 63 |
| Clinical Trials: | 10 |
| Patent Applications: | 4,353 |
| Drug Prices: | Drug price information for FLUDROCORTISONE ACETATE |
| DailyMed Link: | FLUDROCORTISONE ACETATE at DailyMed |
Recent Clinical Trials for FLUDROCORTISONE ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme LLC | Phase 3 |
| Orion Corporation, Orion Pharma | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Barr | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 040425-001 | Jan 21, 2003 | AB | RX | No | 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 | |||
| Chartwell Rx | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 216013-001 | Oct 27, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma Pharms | FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 091302-001 | Jul 22, 2011 | DISCN | 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 |
