DERMACORT Drug Patent Profile
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When do Dermacort patents expire, and when can generic versions of Dermacort launch?
Dermacort is a drug marketed by Monarch Pharms and Solvay and is included in three NDAs.
The generic ingredient in DERMACORT is hydrocortisone. There is one drug master file entry for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dermacort
A generic version of DERMACORT was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for DERMACORT?
- What are the global sales for DERMACORT?
- What is Average Wholesale Price for DERMACORT?
Summary for DERMACORT
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 8 |
| DailyMed Link: | DERMACORT at DailyMed |
Recent Clinical Trials for DERMACORT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Oncology Group | Phase 1 |
| National Cancer Institute (NCI) | Phase 1 |
| EsPhALL network I-BFM Study Group | Phase 3 |
US Patents and Regulatory Information for DERMACORT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Monarch Pharms | DERMACORT | hydrocortisone | CREAM;TOPICAL | 083011-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Solvay | DERMACORT | hydrocortisone | LOTION;TOPICAL | 084573-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Solvay | DERMACORT | hydrocortisone | LOTION;TOPICAL | 086462-001 | 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 DERMACORT
| 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 |
