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Clofarabine - Generic Drug Details
What are the generic drug sources for clofarabine and what is the scope of patent protection?
Clofarabine
is the generic ingredient in two branded drugs marketed by Abon Pharms Llc, Accord Hlthcare, Amneal, Dr Reddys Labs Ltd, Gland Pharma Ltd, Hospira Inc, Meitheal, MSN, Mylan Labs Ltd, Novast Labs, and Genzyme, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for clofarabine. Ten suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for clofarabine
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 11 |
| NDAs: | 11 |
| Drug Master File Entries: | 11 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 163 |
| Patent Applications: | 7,547 |
| 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 |
|---|---|
| Medexus Pharma, Inc. | Phase 2 |
| Omar Mian | Early Phase 1 |
| Trethera | Phase 1 |
Generic filers with tentative approvals for CLOFARABINE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try it Free | ⤷ Try it Free | 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 | NDA | Submissiondate |
|---|---|---|---|---|
| CLOLAR | SOLUTION;INTRAVENOUS | clofarabine | 021673 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gland Pharma Ltd | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 207831-001 | Oct 31, 2018 | AP | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Abon Pharms Llc | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 204029-001 | May 9, 2017 | AP | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Msn | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 209775-001 | Dec 6, 2017 | AP | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Mylan Labs Ltd | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 208860-001 | Nov 6, 2017 | AP | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Amneal | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 208857-001 | Nov 6, 2017 | AP | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Dr Reddys Labs Ltd | CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 205375-001 | Nov 6, 2017 | AP | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| >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 | ⤷ Try it Free | ⤷ Try it Free |
| Genzyme | CLOLAR | clofarabine | SOLUTION;INTRAVENOUS | 021673-001 | Dec 28, 2004 | ⤷ Try it Free | ⤷ Try it Free |
| Genzyme | CLOLAR | clofarabine | SOLUTION;INTRAVENOUS | 021673-001 | Dec 28, 2004 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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