RANOLAZINE Drug Patent Profile
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When do Ranolazine patents expire, and when can generic versions of Ranolazine launch?
Ranolazine is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Allied, Amneal, Ani Pharms, Aurobindo Pharma, Cadila, Chartwell Rx, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Mankind Pharma, Micro Labs, Novast Labs, Piramal, Praxgen, Rising, Sciegen Pharms Inc, Sun Pharm, Sunshine, Unichem, and Vkt Pharma. and is included in twenty-four NDAs.
The generic ingredient in RANOLAZINE 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 Ranolazine
A generic version of RANOLAZINE was approved as ranolazine by CHARTWELL RX on July 29th, 2013.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for RANOLAZINE?
- What are the global sales for RANOLAZINE?
- What is Average Wholesale Price for RANOLAZINE?
Summary for RANOLAZINE
| US Patents: | 0 |
| Applicants: | 24 |
| NDAs: | 24 |
| Finished Product Suppliers / Packagers: | 27 |
| Raw Ingredient (Bulk) Api Vendors: | 143 |
| Clinical Trials: | 85 |
| Patent Applications: | 2,163 |
| Drug Prices: | Drug price information for RANOLAZINE |
| DailyMed Link: | RANOLAZINE at DailyMed |
Recent Clinical Trials for RANOLAZINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Maria Sklodowska-Curie National Research Institute of Oncology | Phase 3 |
| Polish Medical Research Agency | Phase 3 |
| RenJi Hospital | Phase 4 |
Pharmacology for RANOLAZINE
Medical Subject Heading (MeSH) Categories for RANOLAZINE
Anatomical Therapeutic Chemical (ATC) Classes for RANOLAZINE
Paragraph IV (Patent) Challenges for RANOLAZINE
| 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 RANOLAZINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 211707-002 | May 28, 2019 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novast Labs | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 210668-001 | Sep 27, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Unichem | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 213083-002 | Mar 16, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mankind Pharma | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 212284-001 | Feb 12, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Piramal | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 213085-002 | Jul 25, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Micro Labs | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 211745-002 | Feb 27, 2020 | AB | RX | No | 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 |
EU/EMA Drug Approvals for RANOLAZINE
| 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 |
