HYDROCORTISONE Drug Patent Profile
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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, Paddock Llc, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Nexgen Pharma Inc, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Watson Labs, Cenci, Imperium, Bel Mar, Epic Pharma Llc, Fera Pharms, X Gen Pharms, Genus, Bausch And Lomb, Cosette, Wockhardt, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin Ltd, The J Molner, Cmp Pharma Inc, Abraxis Pharm, Baxter Hlthcare, Cipla, Intl Medication, Encube Ethicals, and Padagis Israel. and is included in one hundred and thirty-three NDAs.
The generic ingredient in HYDROCORTISONE is hydrocortisone valerate. There are sixty-seven drug master file entries for this compound. Six 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 TARO on August 25th, 1998.
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Questions you can ask:
- What is the 5 year forecast for HYDROCORTISONE?
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Summary for HYDROCORTISONE
| US Patents: | 0 |
| Applicants: | 65 |
| NDAs: | 133 |
| Finished Product Suppliers / Packagers: | 29 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 444 |
| 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 |
See drug prices for HYDROCORTISONE
Recent Clinical Trials for HYDROCORTISONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of North Carolina, Chapel Hill | Phase 4 |
| Merck Sharp & Dohme LLC | Phase 3 |
| Orion Corporation, Orion Pharma | Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 214649-003 | Jul 17, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 080355-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alpharma Us Pharms | HYDROCORTISONE | hydrocortisone | LOTION;TOPICAL | 087315-001 | Jun 7, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 080400-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Taro | HYDROCORTISONE VALERATE | hydrocortisone valerate | OINTMENT;TOPICAL | 075043-001 | Aug 25, 1998 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Nexgen Pharma Inc | HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 083140-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | HYDROCORTISONE ACETATE | hydrocortisone acetate | INJECTABLE;INJECTION | 083759-001 | Approved Prior to Jan 1, 1982 | DISCN | No | 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 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/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 |
