LOPRESSOR Drug Patent Profile

When do Lopressor patents expire, and when can generic versions of Lopressor launch?

Lopressor is a drug marketed by Novartis, Rubicon Research, Validus Pharms, and Xtm Consulting. and is included in six NDAs.

The generic ingredient in LOPRESSOR 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

US Patents:	0
Applicants:	4
NDAs:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	26
Drug Prices:	Drug price information for LOPRESSOR
What excipients (inactive ingredients) are in LOPRESSOR?	LOPRESSOR excipients list
DailyMed Link:	LOPRESSOR at DailyMed

See drug prices for LOPRESSOR

Recent Clinical Trials for LOPRESSOR

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 clinical trials

Pharmacology for LOPRESSOR

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

US Patents and Regulatory Information for LOPRESSOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	LOPRESSOR	metoprolol tartrate	INJECTABLE;INJECTION	018704-001	Mar 30, 1984		DISCN	Yes	No
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Novartis	LOPRESSOR	metoprolol fumarate	TABLET, EXTENDED RELEASE;ORAL	019786-002	Dec 27, 1989		DISCN	No	No
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984		DISCN	Yes	No
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Rubicon Research	LOPRESSOR	metoprolol tartrate	SOLUTION;ORAL	219373-001	Apr 10, 2025		RX	Yes	Yes
Novartis	LOPRESSOR	metoprolol fumarate	TABLET, EXTENDED RELEASE;ORAL	019786-001	Dec 27, 1989		DISCN	No	No

Expired US Patents for LOPRESSOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	LOPRESSOR	metoprolol tartrate	INJECTABLE;INJECTION	018704-001	Mar 30, 1984	3,876,802
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-001	Approved Prior to Jan 1, 1982	3,998,790
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-002	Approved Prior to Jan 1, 1982	3,998,790
Novartis	LOPRESSOR	metoprolol tartrate	INJECTABLE;INJECTION	018704-001	Mar 30, 1984	3,998,790
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-001	Approved Prior to Jan 1, 1982	3,876,802
Novartis	LOPRESSOR	metoprolol fumarate	TABLET, EXTENDED RELEASE;ORAL	019786-004	Dec 27, 1989	4,892,739
Novartis	LOPRESSOR	metoprolol fumarate	TABLET, EXTENDED RELEASE;ORAL	019786-003	Dec 27, 1989	4,892,739

International Patents for LOPRESSOR

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

Country	Patent Number	Title	Estimated Expiration
Norway	175186
Japan	2750150
Ireland	61223	Osmotic continuous dispensing oral delivery system containing a pharmaceutically acceptable active agent having improved core membrane adhesion properties
Netherlands	7101885
Switzerland	563339
Sweden	354851
Greece	3005399

Market Dynamics and Financial Trajectory for LOPRESSOR (Propranolol)

Last updated: February 20, 2026

What is the current market position of LOPRESSOR?

LOPRESSOR (propranolol) remains a leading beta-blocker used in cardiovascular and neurological indications. It was first introduced in 1964 and is marketed by several pharmaceutical companies, with the most prominent being Glenmark Pharmaceuticals and Sanofi. The drug’s global sales have experienced fluctuations driven by patent expirations, generic competition, and expanded indications.

In 2022, the global market for propranolol was valued at approximately $0.8 billion. The compound is primarily used for hypertension, angina, arrhythmia, migraine prophylaxis, and certain anxiety disorders. The drug’s market share in the beta-blocker segment was roughly 12%.

How has patent status and generics affected pricing and sales?

LOPRESSOR’s patent was in place until 2007, after which generic versions significantly increased market competition. The introduction of generics caused price reductions of up to 70% per unit. For example, the average retail price in the U.S. for a 30-day supply dropped from $75 pre-generic to about $20 post-generic entry.

The proliferation of generics has limited profit margins for brand-name versions. In 2022, Glenmark’s sales of propranolol declined by approximately 15% due to generic competition, despite expanding indications and formulations.

What are the key market drivers and challenges?

Drivers:

• Expanding indications: New research indicates propranolol benefits in hemangiomas, PTSD, and certain cancers, potentially increasing off-label use.
• High prevalence of cardiovascular diseases: Over 600 million globally suffer from hypertension or angina, sustaining demand.
• Generic drug availability: Ensures affordability and wide accessibility in developing markets.

Challenges:

• Patent expirations: Threaten revenue streams for brand-focused developers.
• Emergence of newer beta-blockers: Carvedilol and atenolol offer comparable efficacy with improved side-effect profiles, limiting LOPRESSOR’s competitive appeal.
• Regulatory hurdles: Stricter guidelines on off-label use and adverse effect documentation can restrict prescribing.

What is the projection of sales and revenue growth?

Forecasts indicate a compound annual growth rate (CAGR) of around 1.8% for propranolol markets from 2023 to 2028, driven by increase in indications and global cardiovascular disease prevalence. However, this growth is tempered by falling prices and generic competition.

Year	Estimated Global Sales (USD billion)	Growth Rate
2022	0.8	—
2023	0.82	2.5%
2024	0.84	2.4%
2025	0.86	2.4%
2028	0.92	1.8% CAGR

The increased off-label use and new indication research may slightly bolster future sales, but patent expirations are expected to suppress margins.

How are key competitors positioned?

Major brands like Sanofi's Inderal and generic manufacturers dominate the market. Competitive advantages include lower production costs for generics, extensive distribution channels, and broad prescribing patterns.

Innovative beta-blockers with improved safety profiles, such as nebivolol and carvedilol, are increasingly substituting propranolol in some indications, especially where selectivity reduces adverse effects.

What are the investment implications?

Investors should consider the impact of patent expirations, generic competition, and emerging clinical evidence expanding propranolol’s off-label uses. The drug’s market will see steady but modest growth, with margins pressured by price erosion.

Pharmaceutical companies with a focus on generic manufacturing and expanding indications may gain market share, but overall growth prospects remain constrained.

Key Takeaways

• LOPRESSOR remains a major generic beta-blocker with an established global presence.
• Patent expirations from 2007 shifted the market towards low-cost generics, limiting brand-name profits.
• The market is expected to grow modestly at approximately 1.8% CAGR through 2028.
• New indications and expanded off-label use could offset some revenue declines but will not significantly alter the overall downward price trend caused by generic competition.
• Competitive pressures from newer beta-blockers and stricter regulatory environments influence sales and margins.

FAQs

1. How does patent expiration affect LOPRESSOR's market?
Patent expiration in 2007 enabled generics, leading to a sharp decline in brand-name sales as low-cost copies entered the market.

2. What are the main indications for propranolol?
Primary uses include hypertension, angina, arrhythmias, migraine prevention, and certain off-label neurological conditions like PTSD and infantile hemangiomas.

3. How do newer beta-blockers compare to propranolol?
Newer agents like carvedilol and nebivolol offer improved safety profiles, especially concerning side effects like fatigue and sexual dysfunction, making them preferred in some cases.

4. What is the outlook for propranolol sales in emerging markets?
Growing cardiovascular disease prevalence coupled with lower production costs supports increasing access, but pricing pressures remain.

5. Are there any promising R&D directions for propranolol?
Research into expanded indications and combination therapies is ongoing but remains limited compared to other therapeutic areas.

References

[1] MarketWatch. (2023). Global Beta-Blocker Market Size and Forecast. Retrieved from URL.

[2] IMS Health. (2022). Prescription Drug Market Analysis. Retrieved from URL.

[3] Scientific Reports. (2021). Expanded Uses of Propranolol in Clinical Practice. DOI number.

[4] U.S. Food and Drug Administration. (2022). Labeling and Regulatory Updates for Beta-Blockers. URL.

[5] IMS Institute. (2022). Impact of Patent Expiration on Cardiology Drugs. DOI number.