Losartan potassium - Generic Drug Details

What are the generic drug sources for losartan potassium and what is the scope of freedom to operate?

Losartan potassium is the generic ingredient in three branded drugs marketed by Scienture, Organon, Aiping Pharm Inc, Alembic Pharms Ltd, Apotex, Apotex Corp, Aurobindo Pharma, Chartwell Rx, Granules, Graviti Pharms, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, MSN, Mylan, Prinston Inc, Strides Pharma, Teva, Torrent Pharms, Unichem, Watson Labs, and Zydus Pharms Usa Inc, and is included in twenty-seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Losartan potassium has one patent family member in one country.

There are thirty-eight drug master file entries for losartan potassium. Forty-five suppliers are listed for this compound.

Summary for losartan potassium

International Patents:	1
US Patents:	2
Tradenames:	3
Applicants:	27
NDAs:	27
Drug Master File Entries:	38
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	89
Patent Applications:	5,211
Drug Prices:	Drug price trends for losartan potassium
Drug Sales Revenues:	Drug sales revenues for losartan potassium
What excipients (inactive ingredients) are in losartan potassium?	losartan potassium excipients list
DailyMed Link:	losartan potassium at DailyMed

See drug prices for losartan potassium

See drug sales revenues for losartan potassium

Recent Clinical Trials for losartan potassium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ifakara Health Institute (IHI)	PHASE4
Martin Rohacek	PHASE4
Dongzhimen Hospital, Beijing	NA

See all losartan potassium clinical trials

Pharmacology for losartan potassium

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for losartan potassium

Angiotensin II Type 1 Receptor Blockers

Anti-Arrhythmia Agents

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for losartan potassium

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for losartan potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	AB	RX	Yes	No
Macleods Pharms Ltd	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	202230-001	May 30, 2012	AB	RX	No	No
Apotex	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	218551-002	Jun 4, 2024		DISCN	No	No
Zydus Pharms Usa Inc	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	078243-002	Oct 6, 2010	AB	RX	No	No
Lupin Ltd	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	078232-002	Oct 6, 2010	AB	RX	No	No

Expired US Patents for losartan potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-003	Oct 13, 1998	5,608,075
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	5,608,075
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-002	Apr 14, 1995	5,608,075

International Patents for losartan potassium

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2022076746

Supplementary Protection Certificates for losartan potassium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0733366	SPC/GB98/031	United Kingdom		PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0253310	C950009	Netherlands		PRODUCT NAME: LOSARTAN, DESGEWENST IN DE VORM VAN EEN AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 17617 19950314; FIRST REGISTRATION: SE 12209 19940902
0733366	SZ 25/1998	Austria		PRODUCT NAME: LOSARTAN-KALIUM UND HYDROCHLOROTHIAZID
0733366	98C0030	Belgium		PRODUCT NAME: KALII LOSARTAN, HYDROCHLOROTHIAZIDUM; NAT. REGISTRATION NO/DATE: 922 IS 174 F 3 19980223; FIRST REGISTRATION: FR 338 520.7 19950215

Market Dynamics and Financial Trajectory for Losartan Potassium

Last updated: April 20, 2026

What are the current market drivers for Losartan Potassium?

Losartan potassium, an angiotensin II receptor blocker (ARB), is prescribed primarily for hypertension and diabetic nephropathy. The market is driven by the global increase in hypertension prevalence, aging populations, and the expanding adoption of ARBs over ACE inhibitors due to a better side-effect profile. The WHO estimates that over 1.28 billion adults globally had hypertension in 2019, a number projected to rise annually (WHO, 2020).

Factors influencing market growth include:

• Growing incidence of cardiovascular diseases (CVD)
• Increased awareness and diagnosis
• Expanding access in emerging markets
• Introduction of generic formulations reducing costs

How has the patent landscape impacted Losartan Potassium?

The original patent for losartan expired in 2010 in the U.S., opening the market to generic competitors. Patent expirations led to price reductions of approximately 40-60% within two years post-generic entry (IMS Health, 2012). The generic market share in the U.S. reached over 70% by 2015, driven by cost efficiencies and regulatory approvals.

Patent landscape overview:

• Original patent expiration: 2010 (U.S.)
• Generic approval: from 2010 onwards
• Key generics launched by late 2010s
• Patent litigations in select jurisdictions occurred to delay generic entry

What are key market segments and geographic trends?

Segment Breakdown

• Brand Name: Cozaar (Merck), with declining market share post-2010
• Generics: Multiple manufacturers producing losartan potassium

Geographic Trends

• North America: Largest market; driven by high hypertension prevalence and insurance coverage
• Europe: Strong adoption; price pressures exist
• Emerging Markets: Rapid growth due to increasing healthcare infrastructure and awareness; China and India lead expansion

Market share distribution:	Region	Market Share of Losartan (2022)	Growth Rate (Compound Annual Growth Rate, 2021-2026)
North America	40%	4.5%
Europe	20%	3.8%
Asia-Pacific	25%	6.2%
Rest of World	15%	5.1%

What are the revenue and profit projections?

Revenue Trajectory

Global losartan potassium market size was valued at approximately USD 880 million in 2021. It is projected to reach USD 1.2 billion by 2026, with a CAGR of 6.2%.

Key Revenue Drivers

• Increased prescription rates due to hypertension guidelines
• Price competition favoring generics
• Expansion into emerging markets with higher volume growth

Profitability Outlook

Margins for generic losartan range from 12-20%. As generic market penetration increases, average prices decline, but higher volumes sustain aggregate revenues.

Major Players and Market Share

Company	Market Share (2022)	Notable Product Lines
Teva Pharmaceuticals	22%	Losartan generics
Mylan	18%	Losartan generics
Novartis	12%	Bypass formulations
Others	48%	Multiple regional manufacturers

How is the regulatory environment influencing the market?

Regulatory policies shape market access and pricing:

• In the U.S., FDA approvals for generics have accelerated post-2010.
• In Europe, the EMA's approval pathway influences generic diffusion.
• Price controls in countries like India and parts of Europe have compressed margins.

Drug approval timing post-patent expiration influences market entry:

• Typically 12-18 months for generics in the U.S. after filing ANDA
• European markets often see earlier approval processes

What are the anticipated challenges and opportunities?

Challenges

• Market saturation in mature markets
• Price erosion due to generics
• Competition from new ARBs and combination therapies
• Regulatory restrictions on pricing and reimbursement

Opportunities

• Growth in fixed-dose combination drugs
• Use in new indications, such as postsurgical hypertension management
• Expansion into orphan and niche markets

Key Takeaways

• Losartan potassium's market experienced rapid growth following patent expiration in 2010, catalyzing a dominance of generics.
• The global market is expanding, primarily driven by hypertension prevalence and cost reductions through generics.
• Revenue is forecasted to grow steadily, reaching approximately USD 1.2 billion by 2026.
• Competitive pressure from generics and evolving regulatory policies compress margins but also broaden access.
• Emerging markets present lucrative opportunities due to increasing healthcare infrastructure and awareness.

FAQs

Q1: How does the patent expiry of losartan affect market pricing?
Patent expiry enables generics, which reduce prices by 40-60%, leading to significant market share shifts and revenue compression for original manufacturers.

Q2: What are the main competitors in the losartan market?
Key competitors include Teva, Mylan, Novartis, and regional generics producers.

Q3: What is the projected market size for losartan in the next five years?
The global market is expected to reach USD 1.2 billion by 2026, with a CAGR of 6.2%.

Q4: How do regulatory policies influence the market?
Regulatory approvals speed market entry of generics and influence pricing; strict policies may limit margins but expand access.

Q5: Are there new therapeutic applications for losartan?
Research explores losartan in fibrosis and other non-hypertension indications, potentially opening new markets.

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References

[1] World Health Organization. (2020). Hypertension. https://www.who.int/news-room/fact-sheets/detail/hypertension
[2] IMS Health. (2012). Impact of Patent Expiration on Generic Market Share and Pricing.
[3] MarketResearch.com. (2022). Global Losartan Market Analysis.
[4] Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).