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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia NCT07680829	Phase 3	Not Yet Recruiting	Zhejiang Doer Biologics Co., Ltd.	378	2026-08 → 2030-10

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

Medicare Part D Spending

CMS annual spending data for Lovaza (2023)

Total Spending

$7.0M

Total Claims

4,785

Beneficiaries

1,381

Avg Cost/Unit

$6.44

Spending Trend

$2.3M(2021)→$5.9M(2022)→$7.0M(2023)

YoY Change:+37.7%

5yr CAGR:+42.8%

Source: CMS Medicare Part D Spending by Drug (2023). 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.