LYSODREN Drug Patent Profile
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When do Lysodren patents expire, and what generic alternatives are available?
Lysodren is a drug marketed by Hra Pharma and is included in one NDA.
The generic ingredient in LYSODREN is mitotane. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mitotane profile page.
Summary for LYSODREN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 4 |
| Patent Applications: | 4,305 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LYSODREN |
| What excipients (inactive ingredients) are in LYSODREN? | LYSODREN excipients list |
| DailyMed Link: | LYSODREN at DailyMed |
Recent Clinical Trials for LYSODREN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 3 |
| European Network for the Study of Adrenal Tumors (ENS@T) | Phase 3 |
| Amercian Australian Asian Adrenal Alliance (A5) | Phase 3 |
Pharmacology for LYSODREN
| Mechanism of Action | Cytochrome P450 3A4 Inducers |
Anatomical Therapeutic Chemical (ATC) Classes for LYSODREN
US Patents and Regulatory Information for LYSODREN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hra Pharma | LYSODREN | mitotane | TABLET;ORAL | 016885-001 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 LYSODREN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| HRA Pharma Rare Diseases | Lysodren | mitotane | EMEA/H/C/000521 Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established. |
Authorised | no | no | no | 2004-04-28 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
