LEUSTATIN Drug Patent Profile
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When do Leustatin patents expire, and what generic alternatives are available?
Leustatin is a drug marketed by Janssen Pharms and is included in one NDA.
The generic ingredient in LEUSTATIN is cladribine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cladribine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Leustatin
A generic version of LEUSTATIN was approved as cladribine by HIKMA on February 28th, 2000.
Summary for LEUSTATIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 30 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | LEUSTATIN at DailyMed |
Recent Clinical Trials for LEUSTATIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Gerhard C Hildebrandt | Phase 1 |
| Astellas Pharma Inc | Phase 1 |
| AbbVie | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for LEUSTATIN
US Patents and Regulatory Information for LEUSTATIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | LEUSTATIN | cladribine | INJECTABLE;INJECTION | 020229-001 | Feb 26, 1993 | DISCN | Yes | No | ⤷ 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 LEUSTATIN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Merck Europe B.V. | Mavenclad | cladribine | EMEA/H/C/004230 Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features. |
Authorised | no | no | no | 2017-08-22 | |
| Lipomed GmbH | Litak | cladribine | EMEA/H/C/000504 Litak is indicated for the treatment of hairy-cell leukaemia. |
Authorised | no | no | no | 2004-04-14 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
