LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE Drug Patent Profile

Which patents cover Losartan Potassium And Hydrochlorothiazide, and when can generic versions of Losartan Potassium And Hydrochlorothiazide launch?

Losartan Potassium And Hydrochlorothiazide is a drug marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Rx, Granules, Hikma, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms, Torrent Pharms, Unichem, Watson Labs, and Zydus Pharms Usa Inc. and is included in seventeen NDAs.

The generic ingredient in LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.

Summary for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

US Patents:	0
Applicants:	17
NDAs:	17
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	15
Patent Applications:	33
DailyMed Link:	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
Shanghai Jiao Tong University School of Medicine	Phase 4
Kyushu University	Phase 3
Federico II University	Phase 4

See all LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

US Patents and Regulatory Information for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent Pharms	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	090528-003	Apr 6, 2010		DISCN	No	No
Mylan	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	091652-002	Apr 6, 2010		DISCN	No	No
Zydus Pharms Usa Inc	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	078385-001	Oct 6, 2010	AB	RX	No	No

Market Dynamics and Financial Trajectory for Losartan Potassium and Hydrochlorothiazide

Last updated: February 20, 2026

What is the current market size for Losartan Potassium and Hydrochlorothiazide?

The combined global market for combination antihypertensive drugs, primarily Losartan Potassium and Hydrochlorothiazide, was valued at approximately USD 3.2 billion in 2022. The segment is expected to grow at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2030. The United States accounts for nearly 40% of sales, with Europe contributing another 20%. The rest of the world, including Asia-Pacific and Latin America, holds the remaining market share.

What are the primary drivers influencing market growth?

• Increasing prevalence of hypertension and cardiovascular diseases. An aging population and rising obesity rates contribute to higher patient demand.
• Generic drug availability. Patent expirations over the past decade have led to a surge in low-cost generics, increasing accessibility.
• Policy shifts favoring cost-effective treatments. Healthcare systems worldwide prioritize generics to reduce expenditures.
• Expanding use in combination therapies. Regulatory agencies approve fixed-dose combinations to improve patient compliance.

What are the key regulatory and patent considerations?

• Patent expirations. Losartan’s patent protection expired around 2010 in the U.S., enabling generic entrants.
• Regulatory approvals. The U.S. Food and Drug Administration (FDA) regularly updates guidelines for combination antihypertensives, influencing formulation development.
• Orphan drug status. No recent orphan designations; the drug remains a standard treatment option.

How competitive is the market landscape?

• Five global generic manufacturers hold the majority of sales. Major players include Teva Pharmaceutical Industries, Mylan (now part of Viatris), and Sandoz.
• Several brand-name formulations exist, though market share is concentrated among generics.
• Innovative combination formulations (e.g., extended-release variants) are under development to maintain market relevance.

What are the financial trends forecasted for the next decade?

Year	Estimated Market Size (USD billion)	CAGR	Notes
2023	3.2	4.2%	Baseline
2025	3.75		Slight acceleration anticipated
2030	4.9		Due to increased hypertension prevalence

The profitability of generics continues to decline marginally due to price compression, but volume growth offsets margin erosion. Manufacturers investing in biosimilar and fixed-dose combination innovations expect to maintain or increase revenue streams.

What are future market opportunities and challenges?

Opportunities:

• Development of extended-release and combination formulations.
• Expansion into emerging markets with rising hypertension rates.
• Integration of digital health solutions for adherence tracking.

Challenges:

• Price competition among generic manufacturers.
• Regulatory hurdles for new formulations.
• Patent litigation risks for branded formulations.

Final analysis

The market for Losartan Potassium and Hydrochlorothiazide will sustain growth over the next decade, driven primarily by increasing global hypertension prevalence and the proliferation of generic options. Procurement strategies should focus on cost-effectiveness and pipeline innovation to sustain margins amidst competitive pressures.

Key Takeaways

• The global market size was USD 3.2 billion in 2022, expected to reach USD 4.9 billion by 2030.
• The CAGR from 2023 to 2030 is projected at 4.2%.
• Generic manufacturers dominate, with the top five companies holding significant market share.
• Innovations in formulations and expansion into emerging markets offer growth opportunities.
• Price competition and regulatory challenges could impact profitability.

FAQs

1. How does patent expiration influence market dynamics?

Patent expiration opens the market for generic competitors, reducing prices and increasing market volume, which causes a shift away from branded products.

2. Are there any notable regulatory changes impacting this market?

The FDA and EMA have streamlined approval pathways for combination drugs, encouraging generic development but increasing regulatory complexity for new formulations.

3. What is the outlook for branded Losartan formulations?

Branded formulations are losing market share to generics but may retain niche segments through specialized formulations or therapeutic advantages.

4. How significant is market penetration in emerging markets?

Emerging markets, including China and India, are experiencing rapid hypertension growth, representing expanding opportunities for low-cost generic drugs.

5. What role do biosimilars play in the future of this market?

While biosimilars are more relevant to biologic drugs, the success of fixed-dose combinations may be enhanced by biosimilar development for associated biologic therapies.

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References

[1] MarketWatch. (2023). Hypertensive combination drugs market report. Retrieved from https://www.marketwatch.com

[2] Allied Market Research. (2023). Global antihypertensive drugs market forecast.

[3] U.S. FDA. (2023). Approved drug products with therapeutic equivalents.

[4] World Health Organization. (2022). Global status report on noncommunicable diseases.