HC (HYDROCORTISONE) Drug Patent Profile
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Which patents cover Hc (hydrocortisone), and what generic alternatives are available?
Hc (hydrocortisone) is a drug marketed by C And M Pharma and is included in two NDAs.
The generic ingredient in HC (HYDROCORTISONE) 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 Hc (hydrocortisone)
A generic version of HC (HYDROCORTISONE) 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 HC (HYDROCORTISONE)?
- What are the global sales for HC (HYDROCORTISONE)?
- What is Average Wholesale Price for HC (HYDROCORTISONE)?
Summary for HC (HYDROCORTISONE)
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 444 |
| Patent Applications: | 4,405 |
| DailyMed Link: | HC (HYDROCORTISONE) at DailyMed |
-patent-expirations.png "HC (HYDROCORTISONE) drug patent expirations")
Recent Clinical Trials for HC (HYDROCORTISONE)
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of North Carolina, Chapel Hill | Phase 4 |
| Orion Corporation, Orion Pharma | Phase 3 |
| Merck Sharp & Dohme LLC | Phase 3 |
US Patents and Regulatory Information for HC (HYDROCORTISONE)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C And M Pharma | HC (HYDROCORTISONE) | hydrocortisone | CREAM;TOPICAL | 080482-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| C And M Pharma | HC (HYDROCORTISONE) | hydrocortisone | OINTMENT;TOPICAL | 080481-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| C And M Pharma | HC (HYDROCORTISONE) | hydrocortisone | CREAM;TOPICAL | 080482-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| C And M Pharma | HC (HYDROCORTISONE) | hydrocortisone | OINTMENT;TOPICAL | 080481-001 | 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 HC (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 |
