CLOFARABINE - Generic Drug Details
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What are the generic sources for clofarabine and what is the scope of freedom to operate?
Clofarabine
is the generic ingredient in two branded drugs marketed by Abon Pharms Llc, Accord Hlthcare, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hospira, Meitheal, MSN, Mylan Labs Ltd, Novast Labs, and Genzyme, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for clofarabine. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for CLOFARABINE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 12 |
NDAs: | 12 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 106 |
Clinical Trials: | 166 |
Patent Applications: | 5,901 |
Drug Prices: | Drug price trends 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 |
---|---|
John Horan, MD | Phase 1/Phase 2 |
GlycoMimetics Incorporated | Phase 1/Phase 2 |
Vastra Gotaland Region | Phase 3 |
Generic filers with tentative approvals for CLOFARABINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 20MG/20ML | INJECTABLE;INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 210283-001 | Dec 27, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abon Pharms Llc | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 204029-001 | May 9, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novast Labs | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 210270-001 | Sep 14, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Genzyme | CLOLAR | clofarabine | SOLUTION;INTRAVENOUS | 021673-001 | Dec 28, 2004 | AP | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for CLOFARABINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Genzyme | CLOLAR | clofarabine | SOLUTION;INTRAVENOUS | 021673-001 | Dec 28, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Genzyme | CLOLAR | clofarabine | SOLUTION;INTRAVENOUS | 021673-001 | Dec 28, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Genzyme | CLOLAR | clofarabine | SOLUTION;INTRAVENOUS | 021673-001 | Dec 28, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
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