![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Wednesday, February 24, 2021 10:12:48 AM
***********************************************************
Benecard comes right out and says HIKMA's version is for CAD - DIRECT INFRINGEMENT !!!
https://www.benecard.com/generic-for-vascepa-capsules-approved/
May 22, 2020
The U.S. FDA has approved Hikma Pharmaceuticals’ icosapent ethyl 1g capsules as a generic for Amarin’s Vascepa® (icosapent ethyl). The products are prescription-only fish oil derivatives indicated to reduce cardiovascular (CV) risks in certain patient populations.
Specifically, icosapent ethyl is approved as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients who have elevated triglyceride (TG) levels (≥ 150mg/dL) and established CV disease, or who have diabetes mellitus and two or more additional risk factors for CV disease. It is also approved as an adjunct to diet to reduce TG levels in adult patients who have severe (≥ 500mg/dL) hypertriglyceridemia.
Recommended dosing for icosapent ethyl is 2g twice daily, taken with food. Capsules should be swallowed whole. Prior to treatment, the patient’s lipid levels should be assessed, and any additional causes of high triglyceride levels should be identified and managed as appropriate. Patients should engage in appropriate nutritional intake and physical activity before starting icosapent ethyl, and this should continue during treatment.
Although the FDA has granted approval for Hikma’s generic, Amarin is currently in the process of appealing the invalidation of six Vascepa patents. Should Hikma or another generic manufacturer launch an equivalent to Vascepa before a final legal determination is made, they would do so at risk and could be held liable for damages due to patent infringement if Amarin wins its appeal.
Hikma has not announced launch or pricing plans for its icosapent ethyl 1g capsules.
Vascepa first received FDA approval in 2012 and is available in 0.5g capsules as well as 1g capsules.
Recent AMRN News
- Latest Research Highlighting VASCEPA®/VAZKEPA® (icosapent ethyl) REDUCE-IT® Subgroup Data and New Mechanistic Insights into Eicosapentaenoic Acid (EPA) to be Presented at European Society of Cardiology (ESC) Congress • GlobeNewswire Inc. • 08/22/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/05/2024 09:30:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:46 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/31/2024 11:05:34 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 07/31/2024 11:05:26 AM
- Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update • GlobeNewswire Inc. • 07/31/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/29/2024 09:30:08 PM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal • GlobeNewswire Inc. • 07/17/2024 08:15:00 PM
- Amarin to Report Second Quarter 2024 Financial Results and Host Conference Call on July 31, 2024 • GlobeNewswire Inc. • 07/17/2024 12:00:00 PM
- Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR) • GlobeNewswire Inc. • 07/08/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 11:30:10 AM
- Amarin Board of Directors Announces CEO Transition • GlobeNewswire Inc. • 06/04/2024 11:30:00 AM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A. • GlobeNewswire Inc. • 05/28/2024 12:15:23 PM
- Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Amarin Reports First Quarter 2024 Business Update and Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
- Amarin Announces Results of Annual General Meeting of Shareholders • GlobeNewswire Inc. • 04/22/2024 12:00:25 PM
- Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024 • GlobeNewswire Inc. • 04/15/2024 12:00:00 PM
- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
- Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/04/2024 10:30:53 PM
Maybacks Global and Inventel Products To Launch Global 24 Hour Shopping Channel • AHRO • Sep 3, 2024 9:15 AM
UC Asset announces plan of management stock buyback • UCASU • Sep 3, 2024 9:00 AM
Element79 Gold Corp Appoints Warren Levy to Board of Directors • ELMGF • Aug 28, 2024 9:51 AM
Integrated Ventures Announces Strategic Entry Into Health & Wellness Industry with Focus on GLP-1 Products • INTV • Aug 28, 2024 8:30 AM
ELEMENT79 ANNOUNCES UPLISTING TO OTCQB VENTURE MARKET • ELMGF • Aug 26, 2024 10:03 AM
North Bay Resources Announces Gold Assays up to 2.2 Ounces per Ton, Fran Gold Project, British Columbia • NBRI • Aug 26, 2024 10:00 AM