RANEXA Drug Patent Profile
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Which patents cover Ranexa, and what generic alternatives are available?
Ranexa is a drug marketed by Menarini Intl and is included in one NDA.
The generic ingredient in RANEXA is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ranolazine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ranexa
A generic version of RANEXA was approved as ranolazine by CHARTWELL RX on July 29th, 2013.
Summary for RANEXA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 143 |
Clinical Trials: | 46 |
Patent Applications: | 2,163 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for RANEXA |
Drug Sales Revenues: | Drug sales revenues for RANEXA |
What excipients (inactive ingredients) are in RANEXA? | RANEXA excipients list |
DailyMed Link: | RANEXA at DailyMed |
Recent Clinical Trials for RANEXA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Policlinico Universitario Agostino Gemelli | Phase 4 |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Phase 4 |
IRCCS San Raffaele | Phase 2 |
Pharmacology for RANEXA
Anatomical Therapeutic Chemical (ATC) Classes for RANEXA
Paragraph IV (Patent) Challenges for RANEXA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
RANEXA | Extended-release | ranolazine | 500 mg and 1000 mg | 021526 | 1 | 2010-05-17 |
US Patents and Regulatory Information for RANEXA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-001 | Feb 12, 2007 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-002 | Jan 27, 2006 | DISCN | Yes | No | ⤷ 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 RANEXA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-001 | Feb 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-001 | Feb 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-002 | Jan 27, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-001 | Feb 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for RANEXA
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 RANEXA
See the table below for patents covering RANEXA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Czech Republic | 20022996 | ⤷ Try a Trial | |
Poland | 247722 | ⤷ Try a Trial | |
Denmark | 168535 | ⤷ Try a Trial | |
Canada | 1256874 | ARYLOXY ET ARYLTHIO- HYDROXYPROPYLPIPERAZINYLACETANILIDES CARDIOSELECTIFS QUI MODIFIENT L'ENTREE DE CALCIUM (CARDIOSELECTIVE ARYLOXY AND ARYLTHIO-HYDROXYPROPYL PIPERAZINYL ACETANILIDES WHICH AFFECT CALCIUM ENTRY) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RANEXA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1109558 | 2008/034 | Ireland | ⤷ Try a Trial | PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709 |
1109558 | 09C0001 | France | ⤷ Try a Trial | PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714 |
1109558 | 122008000065 | Germany | ⤷ Try a Trial | PRODUCT NAME: RANOLAZIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080709 |
1109558 | C01109558/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: ROCHE PALTO ALTO LLC, US |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |