CLADRIBINE Drug Patent Profile
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Which patents cover Cladribine, and when can generic versions of Cladribine launch?
Cladribine is a drug marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, and Mylan Labs Ltd. and is included in four NDAs.
The generic ingredient in CLADRIBINE 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 Cladribine
A generic version of CLADRIBINE was approved as cladribine by HIKMA on February 28th, 2000.
Summary for CLADRIBINE
Recent Clinical Trials for CLADRIBINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Florida | Phase 2 |
| First Affiliated Hospital Bengbu Medical College | Phase 2 |
| Suzhou Hospital of Traditional Chinese Medicine | N/A |
Pharmacology for CLADRIBINE
| Drug Class | Purine Antimetabolite |
Medical Subject Heading (MeSH) Categories for CLADRIBINE
Anatomical Therapeutic Chemical (ATC) Classes for CLADRIBINE
Paragraph IV (Patent) Challenges for CLADRIBINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MAVENCLAD | Tablets | cladribine | 10 mg | 022561 | 1 | 2022-04-07 |
US Patents and Regulatory Information for CLADRIBINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | CLADRIBINE | cladribine | INJECTABLE;INJECTION | 076571-001 | Apr 22, 2004 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan Labs Ltd | CLADRIBINE | cladribine | INJECTABLE;INJECTION | 200510-001 | Oct 6, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | CLADRIBINE | cladribine | INJECTABLE;INJECTION | 075405-001 | Feb 28, 2000 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hisun Pharm Hangzhou | CLADRIBINE | cladribine | INJECTABLE;INJECTION | 210856-001 | Nov 25, 2019 | AP | RX | No | 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 CLADRIBINE
| 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 |
