CORTALONE Drug Patent Profile
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Which patents cover Cortalone, and what generic alternatives are available?
Cortalone is a drug marketed by Halsey and is included in one NDA.
The generic ingredient in CORTALONE is prednisolone. There are eighty-eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the prednisolone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cortalone
A generic version of CORTALONE was approved as prednisolone by ZHEJIANG XIANJU on May 2nd, 2024.
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Questions you can ask:
- What is the 5 year forecast for CORTALONE?
- What are the global sales for CORTALONE?
- What is Average Wholesale Price for CORTALONE?
Summary for CORTALONE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 94 |
| Clinical Trials: | 10 |
| Patent Applications: | 4,858 |
| DailyMed Link: | CORTALONE at DailyMed |
Recent Clinical Trials for CORTALONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Oncology Group | Phase 2 |
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| Children's Oncology Group | Phase 1/Phase 2 |
US Patents and Regulatory Information for CORTALONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Halsey | CORTALONE | prednisolone | TABLET;ORAL | 080304-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Halsey | CORTALONE | prednisolone | TABLET;ORAL | 080304-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Halsey | CORTALONE | prednisolone | TABLET;ORAL | 080304-001 | 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 CORTALONE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| LE VET B.V. | Equisolon | Prednisolone | EMEA/V/C/002382 Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control. |
Authorised | no | no | no | 2014-03-12 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
