ARRANON Drug Patent Profile
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When do Arranon patents expire, and when can generic versions of Arranon launch?
Arranon is a drug marketed by Sandoz and is included in one NDA.
The generic ingredient in ARRANON is nelarabine. There are two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the nelarabine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Arranon
A generic version of ARRANON was approved as nelarabine by ZYDUS PHARMS on November 17th, 2021.
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Summary for ARRANON
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 13 |
| Patent Applications: | 4,292 |
| Drug Prices: | Drug price information for ARRANON |
| What excipients (inactive ingredients) are in ARRANON? | ARRANON excipients list |
| DailyMed Link: | ARRANON at DailyMed |
Recent Clinical Trials for ARRANON
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 1/Phase 2 |
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| National Institutes of Health (NIH) | Phase 2 |
Pharmacology for ARRANON
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
US Patents and Regulatory Information for ARRANON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877-001 | Oct 28, 2005 | 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 ARRANON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ARRANON
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Sandoz Pharmaceuticals d.d. | Atriance | nelarabine | EMEA/H/C/000752 Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens., , Due to the small patient populations in these disease settings, the information to support these indications is based on limited data., |
Authorised | no | no | no | 2007-08-22 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ARRANON
See the table below for patents covering ARRANON around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 9201456 | ⤷ Sign Up | |
| South Korea | 187326 | ⤷ Sign Up | |
| German Democratic Republic | 293962 | VERFAHREN ZUR HERSTELLUNG EINER PHARMAZEUTISCHEN FORMULIERUNG | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARRANON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0294114 | 300302 | Netherlands | ⤷ Sign Up | 300302, 20080527, EXPIRES: 20130526 |
| 0294114 | 2007C/063 | Belgium | ⤷ Sign Up | PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070823 |
| 0294114 | C00294114/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: NELARABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57899 08.08.2007 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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