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.
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Questions you can ask:
- What is the 5 year forecast for RANEXA?
- What are the global sales for RANEXA?
- What is Average Wholesale Price for RANEXA?
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-002 | Jan 27, 2006 | DISCN | Yes | No | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-002 | Jan 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-002 | Jan 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-001 | Feb 12, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-002 | Jan 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-002 | Jan 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-001 | Feb 12, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Israel | 175371 | ⤷ Sign Up | |
Australia | 4009201 | ⤷ Sign Up | |
Poland | 196668 | ⤷ Sign Up | |
Czech Republic | 20010879 | ⤷ Sign Up | |
Germany | 122008000065 | ⤷ Sign Up | |
Norway | 841968 | ⤷ Sign Up | |
Germany | 69901570 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RANEXA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1109558 | 09C0001 | France | ⤷ Sign Up | PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714 |
1109558 | CA 2008 00051 | Denmark | ⤷ Sign Up | PRODUCT NAME: RANOLAZIN ELLER ET SALT DERAF |
1109558 | 300371 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
1109558 | 91504 | Luxembourg | ⤷ Sign Up | 91504, EXPIRES: 20230709 |
1109558 | 341 | Finland | ⤷ Sign Up | |
1109558 | C 2008 020 | Romania | ⤷ Sign Up | PRODUCT NAME: RANOLAZINA SAU O SARE SAU SOLVAT AL ACESTEIA(+/-)-N-(2,6-DIMETILFENIL)-2-[4-[2-HIDROXI-3-(2-METOXIFENOXI)PROPIL]PIPERAZIN-1- IL]ACETAMIDA SAU O SARE SAU SOLVAT ALACESTEIA; NATIONAL AUTHORISATION NUMBER: EMEA EU/1/08/462/001, EMEA EU/1/08/462/002, EMEA EU/1/08/462/003, EMEA EU/1/08/462/004, EMEA EU/1/08/462/005, EMEA EU/1/08/462/006 ; DATE OF NATIONAL AUTHORISATION: 20080709; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/08/462/001, EMEA EU/1/08/462/002, EMEA EU/1/08/462/003, EMEA EU/1/08/462/004, EMEA EU/1/08/462/005, EMEA EU/1/08/462/006 ; DATE OF FIRST AUTHORISATION IN EEA: 20080709 |
1109558 | SPC/GB08/058 | United Kingdom | ⤷ Sign Up | 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 |