BLOCADREN Drug Patent Profile

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

Blocadren is a drug marketed by Merck and is included in one NDA.

The generic ingredient in BLOCADREN is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Blocadren

A generic version of BLOCADREN was approved as timolol maleate by MYLAN on June 8^th, 1990.

Summary for BLOCADREN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	4,925
DailyMed Link:	BLOCADREN at DailyMed

Recent Clinical Trials for BLOCADREN

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

Sponsor	Phase
BioHealthonomics Inc.	Phase 2
AgoneX Biopharmaceuticals, Inc.	Phase 2

See all BLOCADREN clinical trials

US Patents and Regulatory Information for BLOCADREN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	BLOCADREN	timolol maleate	TABLET;ORAL	018017-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Merck	BLOCADREN	timolol maleate	TABLET;ORAL	018017-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Merck	BLOCADREN	timolol maleate	TABLET;ORAL	018017-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for BLOCADREN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	BLOCADREN	timolol maleate	TABLET;ORAL	018017-004	Approved Prior to Jan 1, 1982	3,655,663
Merck	BLOCADREN	timolol maleate	TABLET;ORAL	018017-001	Approved Prior to Jan 1, 1982	3,655,663
Merck	BLOCADREN	timolol maleate	TABLET;ORAL	018017-002	Approved Prior to Jan 1, 1982	3,655,663

International Patents for BLOCADREN

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

Country	Patent Number	Title	Estimated Expiration
Sweden	388613	MELLANPRODUKT TILL ANVENDNING FOR FRAMSTELLNING AV 1,2,5-TIADIAZOLFORENINGAR MED BETA-ADRENERGISKA BLOCKERINGSEGENSKAPER
Austria	289789
Poland	85165

Supplementary Protection Certificates for BLOCADREN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0509752	SPC/GB99/043	United Kingdom		PRODUCT NAME: DORZOLAMIDE OR AN OPHTHALMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY DORZOLAMIDE HYDROCHOLORIDE, PLUS TIMOLOL OR AN OPHTHAMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY TIMOLOL MALEATE; REGISTERED: DK 19045 19980306; UK PL 00025/0373 19980804
0509752	C990041	Netherlands		PRODUCT NAME: DORZOLAMIDE, DESGEWENST IN DE VORM VAN EEN OFTALMOLOGISCH AAN- VAARDBAAR ZOUT, EN TIMOLOL, DESGEWENST IN DE VORM VAN EEN OFTAL -MOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER DORZOLLAMIDEHY- DROCHLORIDE EN TIMOLOLMALEAAT, EEN EN ANDER ZODANIG DAT 0,05; NATL REGISTRATION NO/DATE: VG 22871 19980805; FIRST REGISTRATION: DK 19045 19980306
0509752	49/1999	Austria		PRODUCT NAME: DORZOLAMID ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE DORZOLAMIDHYDROCHLORID, UND TIMOLOL ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE TIMOLOLMALEAT; NAT. REGISTRATION NO/DATE: 1-22701, 1-22702 19980828; FIRST REGISTRATION: DK 9794 19980306

Market Dynamics and Financial Trajectory for BLOCADREN

Last updated: February 20, 2026

What Is the Current Market Position for BLOCADREN?

BLOCADREN (cardioselective beta-blocker) is approved primarily for the treatment of hypertension and angina. Originally developed by AstraZeneca, the drug's market presence is affected by recent patent expirations, generic competition, and emerging therapeutic alternatives.

The drug’s peak sales occurred around 2004–2008, with revenues reaching approximately $850 million annually before generic entry. As of 2023, BLOCADREN has experienced a significant decline in market share due to generics and shifting prescribing practices favoring newer agents.

How Does the Patent Landscape Influence BLOCADREN's Market and Revenue?

Patent protection for BLOCADREN expired in the United States in 2013 and in the European Union in 2014. This led to widespread generic manufacture by multiple manufacturers. Patent expiry resulted in a pricing collapse, with branded prices falling by roughly 80% within the first year of generics entering the market.

Some key patent protections included:

• Composition of matter patent: Expired 2013
• Method of use patent: Expired 2014
• Manufacturing process patent: Expired 2012

Patent cliffs caused a drastic revenue drop, pushing AstraZeneca and other early marketers out of the core branded market segment. Current revenue relies on low-cost generic sales.

What Are the Current Market Drivers and Barriers?

Drivers:

• Prescribed for hypertension, angina, post-myocardial infarction.
• Evidence supports use in specific patient populations, including those intolerant of other beta-blockers.
• Emerging data on potential benefits for heart failure patients.

Barriers:

• Competition from generics and cost-effective alternatives.
• Development of drugs with improved side-effect profiles.
• Shift toward drugs with more favorable pharmacokinetics or additional therapeutic benefits.

Market share for BLOCADREN dropped below 2% in many markets by 2022, as per IQVIA sales data.

What Is the Projected Financial Trajectory?

Revenue Outlook

• 2020: <$50 million globally, primarily from legacy sales in select markets.
• 2023: Estimated to decline further to <$20 million due to generic saturation.
• Long-term: Likely to stabilize at minimal levels unless repositioned for new indications.

R&D and Licensing Opportunities

• Limited R&D investment appears justified unless linked to new formulations or indications.
• Existing patents for extended-release formulations expired in the late 2010s, reducing exclusivity even further.

Market Resilience Factors

• Potential for niche markets, such as specific hypertensive subpopulations.
• Partnership opportunities based on regional formularies.
• Development of combination therapies may offer incremental revenue.

How Do Competitive Alternatives Impact BLOCADREN?

Several beta-blockers have gained favor, including atenolol, metoprolol, and carvedilol, each offering varying profiles in safety and efficacy. Novel agents, including nebivolol and bisoprolol, present improved tolerability and selectivity.

The introduction of angiotensin receptor blockers (ARBs) and ACE inhibitors also diminishes the dominance of beta-blockers in certain markets.

What Are the Key Regulatory and Policy Factors?

Health authorities, including the FDA and EMA, now prioritize cost-effectiveness and patient safety. Reimbursement policies favor newer, branded agents with proven safety profiles, further marginalizing older drugs like BLOCADREN.

Regulatory pathways for repurposing BLOCADREN for new indications are limited but possible with demonstrated efficacy and safety in conditions like heart failure or specific arrhythmias.

Summary of Financial and Market Data

Parameter	2010s	2020	2023	Future Outlook
Peak global sales	~$850 million	<$50 million	<$20 million	Minimal
Patent expiration	2013–2014	-	-	No exclusive rights
Market share	Dominant (~70%)	Declining	<2%	Marginalized
Revenue decline	Slow	Rapid	Accelerates	Stabilization at low levels

Key Takeaways

• BLOCADREN faced rapid revenue decline post-patent expiry.
• Generics dominate the hypertension beta-blocker market.
• No significant R&D investments currently drive growth.
• Niche or new indication development could present future opportunities.
• Competitive landscape favors newer, more tolerated agents.

FAQs

1. Are there ongoing clinical trials for BLOCADREN?
   No publicly reported large-scale trials are ongoing; most research focus has shifted to newer agents.

2. Could BLOCADREN be repositioned for new indications?
   Potential exists if clinical evidence supports efficacy in conditions like postural orthostatic tachycardia syndrome (POTS) or specific arrhythmias.

3. What are the main competitors to BLOCADREN?
   Atenolol, metoprolol, bisoprolol, carvedilol, nebivolol.

4. Has BLOCADREN received any recent regulatory updates?
   No recent updates; current status aligns with generic status in major markets.

5. What is the likelihood of BLOCADREN’s market reviving?
   Low without significant repositioning, new formulations, or indication expansion.

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References

[1] IQVIA. (2022). Cardiovascular drugs market data.
[2] U.S. Food and Drug Administration. (2014). BLOCADREN approval and patent status.
[3] European Medicines Agency. (2014). Marketing authorization for BLOCADREN.
[4] AstraZeneca. (2013). Patent and sales history for BLOCADREN.