HYTONE Drug Patent Profile
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Which patents cover Hytone, and when can generic versions of Hytone launch?
Hytone is a drug marketed by Valeant Intl and Dermik Labs and is included in three NDAs.
The generic ingredient in HYTONE is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Hytone
A generic version of HYTONE 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 HYTONE?
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Summary for HYTONE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,335 |
| DailyMed Link: | HYTONE at DailyMed |
Recent Clinical Trials for HYTONE
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 HYTONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Valeant Intl | HYTONE | hydrocortisone | CREAM;TOPICAL | 080472-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Valeant Intl | HYTONE | hydrocortisone | LOTION;TOPICAL | 080473-004 | Nov 30, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Valeant Intl | HYTONE | hydrocortisone | CREAM;TOPICAL | 080472-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Valeant Intl | HYTONE | hydrocortisone | LOTION;TOPICAL | 080473-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 HYTONE
| 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 |
