HYDROCORTISONE Drug Patent Profile
When do Hydrocortisone patents expire, and what generic alternatives are available?
Hydrocortisone is a drug marketed by Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Chartwell Molecular, Encube, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Naska, Padagis Us, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Teva Pharms, Fougera Pharms, Mericon, Sun Pharma Canada, Paddock Llc, Adaptis, Appco, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hikma, Impax Labs, Impax Labs Inc, Inwood Labs, Nexgen Pharma Inc, Novitium Pharma, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Strides Pharma Intl, Watson Labs, Cenci, Imperium, Bel Mar, Epic Pharma Llc, Sciegen Pharms, X Gen Pharms, Genus, Bausch And Lomb, Cosette Pharms Nc, Wockhardt, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin, The J Molner, Pharmobedient, Abraxis Pharm, Apotex, Baxter Hlthcare, Cipla, Intl Medication, Zydus Pharms, Encube Ethicals, and Padagis Israel. and is included in one hundred and thirty-nine NDAs.
The generic ingredient in HYDROCORTISONE is hydrocortisone valerate. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Hydrocortisone
A generic version of HYDROCORTISONE was approved as hydrocortisone valerate by SUN PHARMA CANADA on August 25th, 1998.
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Questions you can ask:
- What is the 5 year forecast for HYDROCORTISONE?
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- What is Average Wholesale Price for HYDROCORTISONE?
Summary for HYDROCORTISONE
| US Patents: | 0 |
| Applicants: | 72 |
| NDAs: | 139 |
| Finished Product Suppliers / Packagers: | 30 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 482 |
| Patent Applications: | 4,517 |
| Drug Prices: | Drug price information for HYDROCORTISONE |
| Drug Sales Revenues: | Drug sales revenues for HYDROCORTISONE |
| What excipients (inactive ingredients) are in HYDROCORTISONE? | HYDROCORTISONE excipients list |
| DailyMed Link: | HYDROCORTISONE at DailyMed |
Recent Clinical Trials for HYDROCORTISONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Virginia | PHASE3 |
| National Institute of Allergy and Infectious Diseases (NIAID) | PHASE3 |
| Assistance Publique - Hôpitaux de Paris | PHASE3 |
Pharmacology for HYDROCORTISONE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for HYDROCORTISONE
Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE
US Patents and Regulatory Information for HYDROCORTISONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adaptis | HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 217160-002 | Nov 25, 2024 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Purepac Pharm | HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 080395-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Alpharma Us Pharms | HYDROCORTISONE | hydrocortisone | LOTION;TOPICAL | 087315-001 | Jun 7, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Teva | HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 080400-003 | 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 HYDROCORTISONE
| 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 |
