ASPRUZYO SPRINKLE Drug Patent Profile
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Which patents cover Aspruzyo Sprinkle, and what generic alternatives are available?
Aspruzyo Sprinkle is a drug marketed by Spil and is included in one NDA. There are two patents protecting this drug.
This drug has one patent family member in one country.
The generic ingredient in ASPRUZYO SPRINKLE is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ranolazine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aspruzyo Sprinkle
A generic version of ASPRUZYO SPRINKLE was approved as ranolazine by CHARTWELL RX on July 29th, 2013.
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Summary for ASPRUZYO SPRINKLE
International Patents: | 1 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Drug Prices: | Drug price information for ASPRUZYO SPRINKLE |
What excipients (inactive ingredients) are in ASPRUZYO SPRINKLE? | ASPRUZYO SPRINKLE excipients list |
DailyMed Link: | ASPRUZYO SPRINKLE at DailyMed |
US Patents and Regulatory Information for ASPRUZYO SPRINKLE
ASPRUZYO SPRINKLE is protected by two US patents.
Patents protecting ASPRUZYO SPRINKLE
Extended release multiparticulates of ranolazine
Patent Number: 10,898,444
Patent Expiration: ⤷ Subscribe
Extended release multiparticulates of ranolazine
Patent Number: 11,510,878
Patent Expiration: ⤷ Subscribe
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Spil | ASPRUZYO SPRINKLE | ranolazine | GRANULES, EXTENDED RELEASE;ORAL | 216018-002 | Feb 28, 2022 | DISCN | Yes | No | 11,510,878 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Spil | ASPRUZYO SPRINKLE | ranolazine | GRANULES, EXTENDED RELEASE;ORAL | 216018-002 | Feb 28, 2022 | DISCN | Yes | No | 10,898,444 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Spil | ASPRUZYO SPRINKLE | ranolazine | GRANULES, EXTENDED RELEASE;ORAL | 216018-001 | Feb 28, 2022 | DISCN | Yes | No | 11,510,878 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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 ASPRUZYO SPRINKLE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Menarini International Operations Luxembourg S.A. (MIOL) | Ranexa (previously Latixa) | ranolazine | EMEA/H/C/000805 Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists)., |
Authorised | no | no | no | 2008-07-08 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ASPRUZYO SPRINKLE
See the table below for patents covering ASPRUZYO SPRINKLE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3409273 | FORMULATIONS MULTIPARTICULAIRES À LIBÉRATION PROLONGÉE DE RANOLAZINE (EXTENDED RELEASE MULTIPARTICULATES OF RANOLAZINE) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ASPRUZYO SPRINKLE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1109558 | 09C0001 | France | ⤷ Subscribe | PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714 |
1109558 | 2008/034 | Ireland | ⤷ Subscribe | PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709 |
1109558 | SPC/GB08/058 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: RANOLAZINE OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/08/462/001 20080714; UK EU/1/08/462/002 20080714; UK EU/1/08/462/003 20080714; UK EU/1/08/462/004 20080714; UK EU/1/08/462/005 20080714; UK EU/1/08/462/006 20080714 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |