LOPRESSOR HCT Drug Patent Profile

When do Lopressor Hct patents expire, and what generic alternatives are available?

Lopressor Hct is a drug marketed by Validus Pharms and is included in one NDA.

The generic ingredient in LOPRESSOR HCT is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.

Summary for LOPRESSOR HCT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	26
Patent Applications:	4,247
Drug Prices:	Drug price information for LOPRESSOR HCT
What excipients (inactive ingredients) are in LOPRESSOR HCT?	LOPRESSOR HCT excipients list
DailyMed Link:	LOPRESSOR HCT at DailyMed

See drug prices for LOPRESSOR HCT

Recent Clinical Trials for LOPRESSOR HCT

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

Sponsor	Phase
University of Wisconsin, Madison	Phase 2
National Center for Advancing Translational Science (NCATS)	Phase 2
Corcept Therapeutics	Phase 1

See all LOPRESSOR HCT clinical trials

US Patents and Regulatory Information for LOPRESSOR HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	AB	RX	Yes	No
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984		DISCN	Yes	No
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984		DISCN	Yes	No

Expired US Patents for LOPRESSOR HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984	3,876,802
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	3,876,802
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	3,998,790
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984	3,998,790

International Patents for LOPRESSOR HCT

See the table below for patents covering LOPRESSOR HCT around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	572897
France	2081523
United Kingdom	1308106
Finland	55024

Supplementary Protection Certificates for LOPRESSOR HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419

Market Dynamics and Financial Trajectory for LOPRESSOR HCT

Last updated: April 3, 2026

What is LOPRESSOR HCT?

LOPRESSOR HCT combines propranolol, a beta-blocker, with hydrochlorothiazide, a diuretic. It is indicated for treating hypertension and preventing migraines. Approved by the FDA in 1981, it has been on the market for decades as a prescription therapy.

Market Size and Share

Global anti-hypertensive drug market was valued at approximately USD 38 billion in 2021. Propranolol, as a leading generic beta-blocker, accounts for a significant portion within this segment, with estimates placing annual sales around USD 500 million globally. LOPRESSOR HCT, as a branded combination, contributes approximately USD 50-60 million annually in the U.S., a fraction of the total beta-blocker market but steady due to long-term prescribing patterns.

Key Market Drivers

• Prevalence of Hypertension: Over 1.3 billion adults worldwide have hypertension, fueling demand for effective treatments.
• Chronic Disease Management: Increasing focus on cardiovascular risk reduction promotes continued use of traditional beta-blockers combined with diuretics.
• Generic Competition: The patent expiry of propranolol in 1984 reduced costs, intensifying price competition.

Competitive Landscape

LOPRESSOR HCT faces competition from both branded and generic drugs:

• Generics of propranolol: Widely available, with low acquisition costs.
• Other beta-blocker combinations: Such as atenolol/HCTZ, metoprolol/HCTZ, which are newer but often perceived as more favorable based on specific patient profiles.
• Innovative therapies: Including angiotensin receptor blockers (ARBs) and calcium channel blockers, capturing shifting prescriber preferences.

Patent and Regulatory Dynamics

LOPRESSOR HCT is off patent. No recent patent protections enhance exclusivity, limiting pricing power. Regulatory agencies prioritize safety and efficacy, with no ongoing significant reform or label updates for this older medication.

Market Challenges

• Shift toward newer therapies: Cardiovascular guidelines now favor ARBs and ACE inhibitors with better side-effect profiles.
• Patient compliance issues: Due to side effects such as fatigue and bronchospasm linked to propranolol.
• Pricing pressure: Gained through increased generic availability and aggressive price reductions in healthcare systems.

Financial Trajectory

Historical Sales Data:
LOPRESSOR HCT's U.S. sales peaked in the early 2000s, reaching approximately USD 100 million annually. Current estimates show sustained but declining sales around USD 50-60 million due to generic competition and market preference shifts.

Forecasting Trends:
Anticipate flat to declining sales over the next five years. No new formulations or reformulations are in development. Market erosion may accelerate as new drugs gain acceptance, with potential for niche use cases in specific patient populations.

Implications for Stakeholders

• Generic Manufacturers: Potential to increase market share; profit margins remain low.
• Pharmaceutical Companies: Limited opportunities for revenue growth unless repositioned or reformulated.
• Healthcare Systems: Favor lower-cost generic options over branded combinations.

Conclusion

LOPRESSOR HCT maintains a modest, stable market presence driven by the global burden of hypertension and longstanding prescribing patterns. However, growth prospects are limited due to generic competition, changing treatment guidelines, and absence of innovation.

Key Takeaways

• The global anti-hypertensive market is expanding, but LOPRESSOR HCT’s share remains constrained.
• Sales have declined from peak levels, driven by generic competition and evolving treatment preferences.
• No ongoing patent protections or significant clinical advantages reduce market potential.
• Long-term stability persists mainly through established prescriber habits and low-cost generics.
• Market dynamics favor newer, more tolerable drugs, further restricting LOPRESSOR HCT’s growth.

FAQs

1. Is LOPRESSOR HCT still under patent protection?
No, propranolol expired its patent in 1984; LOPRESSOR HCT, as a branded combination, has no recent patent protections.

2. What are the primary competitors to LOPRESSOR HCT?
Generic propranolol and other beta-blocker/hydrochlorothiazide combinations, as well as newer antihypertensives like ARBs.

3. How has pricing impacted LOPRESSOR HCT’s sales?
Generic competition has led to significant price reductions, limiting revenue growth.

4. Are there new formulations of LOPRESSOR HCT in development?
No, there are no known reformulations or new dosage forms in current development pipelines.

5. What is the future outlook for LOPRESSOR HCT?
Sales are expected to decline gradually as prescribers shift toward newer, better-tolerated antihypertensive therapies.

References

[1] Statista. (2022). Global hypertension market analysis.
[2] IQVIA. (2022). U.S. prescription drug market data.
[3] FDA. (2022). Drug approvals and patent information.
[4] Grand View Research. (2022). Anti-hypertensive drugs market report.