NUTRACORT Drug Patent Profile
When do Nutracort patents expire, and what generic alternatives are available?
Nutracort is a drug marketed by Bausch, Healthpoint, and Dow Pharm. and is included in four NDAs.
The generic ingredient in NUTRACORT is hydrocortisone. There is one drug master file entry for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nutracort
A generic version of NUTRACORT was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.
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Questions you can ask:
- What is the 5 year forecast for NUTRACORT?
- What are the global sales for NUTRACORT?
- What is Average Wholesale Price for NUTRACORT?
Summary for NUTRACORT
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 96 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,514 |
| DailyMed Link: | NUTRACORT at DailyMed |
Recent Clinical Trials for NUTRACORT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1 |
| Children's Oncology Group | Phase 1 |
| EsPhALL network I-BFM Study Group | Phase 3 |
US Patents and Regulatory Information for NUTRACORT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | NUTRACORT | hydrocortisone | CREAM;TOPICAL | 080442-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Dow Pharm | NUTRACORT | hydrocortisone | LOTION;TOPICAL | 080443-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bausch | NUTRACORT | hydrocortisone | CREAM;TOPICAL | 080442-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Healthpoint | NUTRACORT | hydrocortisone | GEL;TOPICAL | 084698-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Dow Pharm | NUTRACORT | hydrocortisone | LOTION;TOPICAL | 087644-001 | Aug 24, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Dow Pharm | NUTRACORT | hydrocortisone | LOTION;TOPICAL | 080443-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for NUTRACORT
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharmaceuticals International AG Ireland Branch | Plenadren | hydrocortisone | EMEA/H/C/002185Treatment of adrenal insufficiency in adults. | Authorised | no | no | no | 2011-11-03 | |
| Diurnal Europe B.V. | Alkindi | hydrocortisone | EMEA/H/C/004416Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old). | Authorised | no | no | no | 2018-02-09 | |
| Diurnal Europe B.V. | Efmody | hydrocortisone | EMEA/H/C/005105Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. | Authorised | no | no | no | 2021-05-27 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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