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, Amneal, Ani Pharms, Arthur Grp, Aurobindo Pharma, Cadila, Chartwell Rx, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, I3 Pharms, Mankind Pharma, Micro Labs, Novast Labs, Piramal, Rising, Sciegen Pharms Inc, Sun Pharm, Sunshine, Torrent, Unichem, and Vkt Pharma. and is included in twenty-five NDAs.
The generic ingredient in RANOLAZINE is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-eight 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: | 25 |
NDAs: | 25 |
Finished Product Suppliers / Packagers: | 28 |
Raw Ingredient (Bulk) Api Vendors: | 143 |
Clinical Trials: | 85 |
Patent Applications: | 2,267 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Torrent | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 210407-002 | Feb 4, 2025 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Sun Pharm | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 211707-002 | May 28, 2019 | AB | RX | No | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Micro Labs | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 211745-001 | Feb 27, 2020 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
I3 Pharms | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 213517-001 | Apr 27, 2022 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Vkt Pharma | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 214035-001 | Jan 19, 2022 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Vkt Pharma | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 214035-002 | Jan 19, 2022 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>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 |
Market Dynamics and Financial Trajectory of Ranolazine
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