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LOVAZA

NDA

OMEGA-3-ACID ETHYL ESTERS | N021654 | WAYLIS THERAPEUTICS LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Pronova BioPharma Norge AS v. Apotex Corp. et al 1:2011cv00012 5 patentsOmega-3-Acid Ethyl Esters	D. Del.	2011-01-05	Terminated 2011-03-31	—
Pronova BioPharma Norge AS v. Par Pharmaceutical Inc. et al 1:2010cv00801 1 patentANDA 91018omega-3-acid ethyl esters	D. Del.	2010-09-20	Terminated 2011-07-27	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Crowell & Moring LLP - Citizen Petition FDA-2013-P-0148 · 4 docket documents Crowell & Moring LLP filed this citizen petition on behalf of an unnamed petitioner requesting that the FDA Commissioner amend the adopted strength for Lovaza (omega-3-acid ethyl esters) Capsules, currently listed in the Orange Book as "1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATT	Other	2013-03-01	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

33 trials from ClinicalTrials.gov, 1 active, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers NCT03598309	Phase 2	Active	H. Lee Moffitt Cancer Center and Research Institute	19	2019-06-05 → 2026-05
Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis NCT00257283	Phase 4	Completed	Pronova BioPharma	200	2002-11 → 2005-06
Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women NCT01894581	N/A	Completed	University of Colorado, Denver	39	2014-07 → 2014-12
COGNUTRIN in Breast Cancer Survivors NCT01823991	Early Phase 1	Completed	H. Lee Moffitt Cancer Center and Research Institute	36	2014-07-30 → 2018-05-02
Pro-Resolving Mediators in Acute Inflammation in Humans NCT04308889	Early Phase 1	Completed	Brigham and Women's Hospital	19	2018-07-02 → 2022-02-22
Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of the Effects of Epanova and Lovaza on Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) After Low-fat Meals NCT01431690	Phase 1	Completed	AstraZeneca	52	2011-08 → 2011-10
Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids NCT01624727	N/A	Completed	Beth Israel Deaconess Medical Center	338	2009-06 → 2015-01-15
The Effect of Phytosterol Esters of Omega-3 (Vayarol) Versus Omega-3 Acids Ethyl Esters in Reducing Triglyceride Levels NCT01712867	N/A	Completed	Enzymotec	201	2012-10 → 2014-12
Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment NCT00296153	Phase 4	Completed	Pronova BioPharma	51	2006-02 → 2007-10
Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes (T2DM NCT00577590	N/A	Completed	Washington University School of Medicine	78	2003-10 → 2012-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Lovaza (2024)

Total Spending

$7.1M

Total Claims

4,393

Beneficiaries

1,364

Avg Cost/Unit

$7.18

Spending Trend

$2.3M(2021)→$5.9M(2022)→$7.0M(2023)→$7.1M(2024)

YoY Change:+11.6%

5yr CAGR:+31.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs3 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

CRODA EUROPE LTDOMEGA-3-ACID ETHYL ESTERS

DMF 221062008

HUATAI BIOPHARM INCOMEGA-3-ACID ETHYL ESTERS USP

DMF 222852008

CHEMPORT INCOMEGA-3-ACID ETHYL ESTERS

DMF 253422011

BASF ASOMEGA-3-ACID ETHYL ESTERS

DMF 260562012

KINOMEGA BIOPHARM INCOMEGA-3-ACID ETHYL ESTERS

DMF 265702012

CHEMO IBERICA SAOMEGA-3-ACID ETHYL ESTERS

DMF 282462014

BASF ASOMEGA-3-ACID ETHYL ESTERS CAPSULES

DMF 291922015

SHANDONG YUWANG PHARMACEUTICAL CO LTDOMEGA-3-ACID ETHYL ESTERS

DMF 353012020

SICHUAN GOWELL PHARMACEUTICAL CO LTDOMEGA-3-ACID ETHYL ESTERS 90

DMF 419372025

SHANDONG XINHUA PHARMACEUTICAL CO LTDOMEGA-3-ACID ETHYL ESTERS 90

DMF 425422025

OLON SPAInactiveOMEGA-3-ACID ETHYL ESTERS

DMF 222842008

HUATAI BIOPHARM INCInactiveOMEGA-3-ACID ETHYL ESTERS (NON-STERILE, BULK FORM)

DMF 265592012

SKUNY BIOSCIENCE CO LTDInactiveOMEGA-3-ACID ETHYL ESTERS 90

DMF 280452014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Sep 8, 2020	SUPPL -44	View Letter (PDF)
Apr 4, 2019	SUPPL -43	View Letter (PDF)
May 14, 2014	SUPPL -41	View Letter (PDF)
Jun 27, 2013	SUPPL -37	View Letter (PDF)
Sep 6, 2012	SUPPL -34	View Letter (PDF)
Sep 21, 2011	SUPPL -33	View Letter (PDF)
Dec 28, 2010	SUPPL -30	View Letter (PDF)
Nov 10, 2009	SUPPL -22	View Letter (PDF)
Apr 21, 2009	SUPPL -23	View Letter (PDF)
Jun 6, 2008	SUPPL -21	View Letter (PDF)
Jan 9, 2008	SUPPL -15	View Letter (PDF)
Nov 8, 2007	SUPPL -14	View Letter (PDF)
Jul 5, 2007	SUPPL -16	View Letter (PDF)
Feb 12, 2007	SUPPL -4	View Letter (PDF)
Jul 13, 2006	SUPPL -7	View Letter (PDF)
Nov 16, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 10, 2004

No patent or exclusivity listings for this strength.