ARRANON Drug Patent Profile
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Which patents cover Arranon, 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. Nine 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.
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: | 4,598 |
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 |
The Leukemia and Lymphoma Society | Phase 2 |
Pharmacology for ARRANON
Drug Class | Nucleoside Metabolic Inhibitor |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ARRANON
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 | ⤷ 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877-001 | Oct 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877-001 | Oct 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877-001 | Oct 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Czechoslovakia | 8803635 | METHOD OF ANTIVIRAL SUBSTANCES PRODUCTION | ⤷ Try a Trial |
Monaco | 1935 | ⤷ Try a Trial | |
Australia | 641533 | ⤷ Try a Trial | |
Australia | 8196091 | ⤷ Try a Trial | |
New Zealand | 239025 | 2-AMINO-6-ALKOXY-ARABINO-9H-PURINE ESTERS AND PHARMACEUTICAL FORMULATIONS THEREOF | ⤷ Try a Trial |
Austria | 142636 | ⤷ Try a Trial | |
Greece | 3023776 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARRANON
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0294114 | 55/2007 | Austria | ⤷ Try a Trial | PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070822 |
0294114 | 91370 | Luxembourg | ⤷ Try a Trial | 91370, EXPIRES: 20130527 |
0294114 | C300302 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NELARABINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR BAAR ZOUT, ETHER OF ESTER; REGISTRATION NO/DATE: EU/1/07/403/001 20070822 |
0294114 | 2007C/063 | Belgium | ⤷ Try a Trial | PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070823 |
0294114 | C00294114/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: NELARABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57899 08.08.2007 |
0294114 | 300302 | Netherlands | ⤷ Try a Trial | 300302, 20080527, EXPIRES: 20130526 |
0294114 | SPC/GB08/006 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NELARABINE, OR ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ETHERS, ESTERS, OR SALTS OF SUCH ESTERS THEREOF.; REGISTERED: UK EU/1/07/403/001 20070822 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |