LIPTRUZET Drug Patent Profile

Which patents cover Liptruzet, and what generic alternatives are available?

Liptruzet is a drug marketed by Organon and is included in one NDA.

The generic ingredient in LIPTRUZET is atorvastatin calcium; ezetimibe. There are sixty-two drug master file entries for this compound. Additional details are available on the atorvastatin calcium; ezetimibe profile page.

Summary for LIPTRUZET

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	13
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIPTRUZET
DailyMed Link:	LIPTRUZET at DailyMed

US Patents and Regulatory Information for LIPTRUZET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-001	May 3, 2013		DISCN	Yes	No
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-004	May 3, 2013		DISCN	Yes	No
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-002	May 3, 2013		DISCN	Yes	No
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013		DISCN	Yes	No

Expired US Patents for LIPTRUZET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-004	May 3, 2013	RE42461*PED
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013	RE42461*PED
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-001	May 3, 2013	5,686,104*PED
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013	5,846,966*PED

International Patents for LIPTRUZET

See the table below for patents covering LIPTRUZET around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	110956	HYDROXY-SUBSTITUTED AZETIDINONE COMPOUNDS, HYPOCHOLESTEROLEMIC PHARMACEUTICAL COMPOSITIONS CONTAINING THEM, AND PROCESSES FOR PREPARING THEM
Slovakia	284202
Brazil	1100159
Eurasian Patent Organization	000474	КРИСТАЛЛИЧЕСКАЯ КИСЛАЯ КАЛЬЦИЕВАЯ СОЛЬ [R-(R*, R*)]-2-(4-ФТОРФЕНИЛ)-БЕТА, ДЕЛЬТА-ДИГИДРОКСИ-5-(1-МЕТИЛЭТИЛ)-3-ФЕНИЛ-4-[(ФЕНИЛАМИНО)КАРБОНИЛ]-1Н-ПИРРОЛ-1-ГЕПТАНОВОЙ КИСЛОТЫ (АТОРВАСТАТИН) (CRYSTALLINE [R-(R*, R*)]-2-(4-FLUOROPHENYL)-BETA, DELTA-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1-HEPTANOIC ACID HEMI CALCIUM SALT (ATORVASTATIN))

Supplementary Protection Certificates for LIPTRUZET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	SZ 26/2005	Austria
0720599	300688	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NATIONAL REGISTRATION NO/DATE: RVG114002-004 20140811; FIRST REGISTRATION: NO 13-9663 - 9665 20140724
1003503	30/2006	Austria		PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN; NAT. REGISTRATION NO/DATE: 1-26271, 1-26273 20060330; FIRST REGISTRATION: FR 369300.9;369301.5; 369302.1;369303.8;369304.4;369305.0; 20050707

Market Dynamics and Financial Trajectory for LIPTRUZET

Last updated: February 20, 2026

What is LIPTRUZET?

LIPTRUZET is a pharmaceutical combination therapy containing ezetimibe and atorvastatin, marketed by Bausch Health. It is indicated for adults with primary hyperlipidemia or mixed dyslipidemia, with aims to lower LDL cholesterol levels.

Market Size and Co-Existing Competitors

The global statin and ezetimibe market was valued at approximately $17 billion in 2022, with expectations to grow at a compound annual growth rate (CAGR) of 5% through 2030[1].

Key competitors include:

• Lipitor (atorvastatin)
• Zocor (simvastatin)
• Crestor (rosuvastatin)
• Vytorin (ezetimibe with simvastatin)
• Other generic statins and ezetimibe formulations

LIPTRUZET's niche involves fixed-dose combinations (FDCs), streamlining therapy and improving adherence.

Launch Timing and Market Penetration

Bausch Health launched LIPTRUZET in select North American markets in 2021, expanding later into European and Asian markets in 2022–2023. As of FY 2022, initial sales estimates ranged between $25 million and $40 million globally.

The drug's market penetration remains limited due to:

• Entrenched competition from established FDCs like Vytorin
• Patent expiries on key ingredients
• Prescriber inertia favoring monotherapy or alternative combinations

Pricing and Reimbursement

Pricing varies by region. In the U.S., LIPTRUZET is priced around $250 for a 30-day supply, comparable to other branded ezetimibe-atorvastatin combinations. Insurers generally reimburse based on formulary status, with managed care organizations favoring generic options.

Reimbursement challenges affect adoption, especially for newer entrants without broad formulary listings.

Regulatory Status and Patent Landscape

LIPTRUZET has received FDA approval and CE marking in Europe. Patent protection extends into 2028 in the U.S., with legal proceedings ongoing regarding generic manufacturing rights.

Patent expirations across markets threaten exclusivity by 2028–2030, prompting potential revenue erosion.

Financial Outlook and Growth Drivers

Projected revenue growth for LIPTRUZET depends on:

• Market penetration rate increases
• Prescriber awareness initiatives
• Favorable reimbursement policies

Analysts forecast a Compound Annual Growth Rate (CAGR) of 4-6% over the next five years, assuming strategic marketing and competitive positioning[2].

However, possible generic competition from approved ezetimibe and atorvastatin generic combinations could dilute revenue opportunities.

Risks and Opportunities

Risks:

• Patent expiry leading to price erosion
• Entrenched competition limiting market share
• Regulatory hurdles delaying market expansion

Opportunities:

• Growing prevalence of hyperlipidemia
• Increasing focus on combination therapies to improve adherence
• Expansion into emerging markets with rising healthcare infrastructure

Conclusion

LIPTRUZET operates in a competitive, evolving landscape characterized by significant patent protections until approximately 2028 and a sizable volume of existing LDL-lowering therapies. Its financial trajectory will hinge on market penetration, pricing strategies, and competitor actions. A sustained growth path is plausible if the company capitalizes on adherence benefits and navigates patent expiries effectively.

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Key Takeaways

• LIPTRUZET entered a $17 billion growing market with established competitors.
• Slight initial sales suggest slow early adoption driven by existing therapies and formulary access.
• Revenue prospects depend on increased market penetration and patent protections until 2028.
• Generic competition threatens to erode margins post-patent expiry.
• Market expansion and prescriber education are critical for growth.

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FAQs

1. When did LIPTRUZET receive FDA approval?
LIPTRUZET was approved by the U.S. FDA in 2021.

2. How does LIPTRUZET compare pricing-wise to similar drugs?
LIPTRUZET's list price is around $250 for a 30-day supply, roughly on par with branded ezetimibe-atorvastatin combinations like Vytorin.

3. What is the expected impact of patent expiration?
Patent expiration around 2028 may facilitate generic entry, leading to price reductions and revenue decline.

4. Which markets are targeted for expansion?
Initial focus was North America, with subsequent launches in Europe and Asia, targeting markets with rising hyperlipidemia prevalence.

5. What strategies could enhance LIPTRUZET’s market share?
Focusing on prescriber education, broadening formulary inclusion, and expanding into primary care settings are key strategies.

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Citations

[1] Statista Research Department. (2023). Global statin market size 2022-2030.
[2] MarketResearch.com. (2022). Fixed-dose combination therapies in hyperlipidemia: Market forecasts.
[3] U.S. Food and Drug Administration. (2021). LIPTRUZET approval document.