HYDROCORTONE Drug Patent Profile
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Which patents cover Hydrocortone, and when can generic versions of Hydrocortone launch?
Hydrocortone is a drug marketed by Merck and is included in four NDAs.
The generic ingredient in HYDROCORTONE is hydrocortisone. There are sixty-seven drug master file entries 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 Hydrocortone
A generic version of HYDROCORTONE 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 HYDROCORTONE?
- What are the global sales for HYDROCORTONE?
- What is Average Wholesale Price for HYDROCORTONE?
Summary for HYDROCORTONE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 13 |
| DailyMed Link: | HYDROCORTONE at DailyMed |
Recent Clinical Trials for HYDROCORTONE
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 HYDROCORTONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck | HYDROCORTONE | hydrocortisone acetate | INJECTABLE;INJECTION | 008228-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Merck | HYDROCORTONE | hydrocortisone acetate | OINTMENT;OPHTHALMIC, OTIC | 009018-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Merck | HYDROCORTONE | hydrocortisone acetate | INJECTABLE;INJECTION | 008228-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| >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 HYDROCORTONE
| 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 |
