CORTEF Drug Patent Profile
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Which patents cover Cortef, and what generic alternatives are available?
Cortef is a drug marketed by Pharmacia And Upjohn and is included in five NDAs.
The generic ingredient in CORTEF is hydrocortisone acetate. There are sixty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
Summary for CORTEF
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 36 |
| Patent Applications: | 4,415 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CORTEF |
| What excipients (inactive ingredients) are in CORTEF? | CORTEF excipients list |
| DailyMed Link: | CORTEF at DailyMed |
Recent Clinical Trials for CORTEF
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Medical Center Groningen | Early Phase 1 |
| Beth Israel Deaconess Medical Center | Phase 2 |
| The London Clinic | Phase 4 |
Pharmacology for CORTEF
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for CORTEF
US Patents and Regulatory Information for CORTEF
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmacia And Upjohn | CORTEF | hydrocortisone | INJECTABLE;INJECTION | 009864-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pharmacia And Upjohn | CORTEF ACETATE | hydrocortisone acetate | OINTMENT;TOPICAL | 008917-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pharmacia And Upjohn | CORTEF | hydrocortisone | TABLET;ORAL | 008697-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Pharmacia And Upjohn | CORTEF ACETATE | hydrocortisone acetate | OINTMENT;TOPICAL | 008917-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pharmacia And Upjohn | CORTEF | hydrocortisone cypionate | SUSPENSION;ORAL | 009900-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pharmacia And Upjohn | CORTEF | hydrocortisone | TABLET;ORAL | 008697-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Pharmacia And Upjohn | CORTEF ACETATE | hydrocortisone acetate | INJECTABLE;INJECTION | 009378-002 | Approved Prior to Jan 1, 1982 | 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 |
EU/EMA Drug Approvals for CORTEF
| 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/002185 Treatment of adrenal insufficiency in adults. |
Authorised | no | no | no | 2011-11-03 | |
| Diurnal Europe B.V. | Alkindi | hydrocortisone | EMEA/H/C/004416 Replacement 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/005105 Treatment 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 |
