BETA-HC Drug Patent Profile
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When do Beta-hc patents expire, and what generic alternatives are available?
Beta-hc is a drug marketed by Beta Dermac and is included in one NDA.
The generic ingredient in BETA-HC 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 Beta-hc
A generic version of BETA-HC 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 BETA-HC?
- What are the global sales for BETA-HC?
- What is Average Wholesale Price for BETA-HC?
Summary for BETA-HC
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Patent Applications: | 4,332 |
| DailyMed Link: | BETA-HC at DailyMed |
US Patents and Regulatory Information for BETA-HC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Beta Dermac | BETA-HC | hydrocortisone | LOTION;TOPICAL | 089495-001 | Jan 25, 1988 | 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 BETA-HC
| 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 |
