RANEXA Drug Patent Profile
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When do Ranexa patents expire, 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 |
|---|---|---|---|
| Russian Federation | 2207856 | METHOD OF TREATMENT OF CARDIOVASCULAR DISEASES | ⤷ Try a Trial |
| Australia | 760435 | ⤷ Try a Trial | |
| Brazil | 9913626 | ⤷ Try a Trial | |
| Norway | 20011191 | ⤷ 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 | C 2008 020 | Romania | ⤷ Try a Trial | 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 | CA 2008 00051 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RANOLAZIN ELLER ET SALT DERAF |
| 1109558 | PA2008017,C1109558 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006, 0080709 |
| 1109558 | 300371 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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