CLOFARABINE Drug Patent Profile
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When do Clofarabine patents expire, and what generic alternatives are available?
Clofarabine is a drug marketed by Abon Pharms Llc, Accord Hlthcare, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hospira, Meitheal, MSN, Mylan Labs Ltd, and Novast Labs. and is included in eleven NDAs.
The generic ingredient in CLOFARABINE is clofarabine. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the clofarabine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Clofarabine
A generic version of CLOFARABINE was approved as clofarabine by ABON PHARMS LLC on May 9th, 2017.
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Questions you can ask:
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Summary for CLOFARABINE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 106 |
| Clinical Trials: | 166 |
| Patent Applications: | 4,294 |
| Drug Prices: | Drug price information for CLOFARABINE |
| What excipients (inactive ingredients) are in CLOFARABINE? | CLOFARABINE excipients list |
| DailyMed Link: | CLOFARABINE at DailyMed |
Recent Clinical Trials for CLOFARABINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlycoMimetics Incorporated | Phase 1/Phase 2 |
| John Horan, MD | Phase 1/Phase 2 |
| Vastra Gotaland Region | Phase 3 |
Pharmacology for CLOFARABINE
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for CLOFARABINE
Paragraph IV (Patent) Challenges for CLOFARABINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CLOLAR | Injection | clofarabine | 1 mg/mL, 20 mL vial | 021673 | 1 | 2012-02-23 |
US Patents and Regulatory Information for CLOFARABINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abon Pharms Llc | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 204029-001 | May 9, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 210283-001 | Dec 27, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 205375-001 | Nov 6, 2017 | AP | RX | 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 CLOFARABINE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| ORPHELIA Pharma SAS | Ivozall | clofarabine | EMEA/H/C/005039 Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis. |
Authorised | yes | no | no | 2019-11-14 | |
| Sanofi B.V. | Evoltra | clofarabine | EMEA/H/C/000613 Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis. |
Authorised | no | no | no | 2006-05-29 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
