COLOCORT Drug Patent Profile
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Which patents cover Colocort, and what generic alternatives are available?
Colocort is a drug marketed by Chartwell and is included in one NDA.
The generic ingredient in COLOCORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Colocort
A generic version of COLOCORT was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.
Summary for COLOCORT
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 1 |
Patent Applications: | 5,558 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for COLOCORT |
DailyMed Link: | COLOCORT at DailyMed |
Recent Clinical Trials for COLOCORT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hospital for Special Surgery, New York | Phase 4 |
Pharmacology for COLOCORT
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for COLOCORT
US Patents and Regulatory Information for COLOCORT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chartwell | COLOCORT | hydrocortisone | ENEMA;RECTAL | 075172-001 | Dec 3, 1999 | AB | RX | 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 COLOCORT
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 |