NORMODYNE Drug Patent Profile

Which patents cover Normodyne, and when can generic versions of Normodyne launch?

Normodyne is a drug marketed by Schering and is included in two NDAs.

The generic ingredient in NORMODYNE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Normodyne

A generic version of NORMODYNE was approved as labetalol hydrochloride by HERITAGE PHARMA on August 3^rd, 1998.

Summary for NORMODYNE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	153
Clinical Trials:	2
Patent Applications:	1,191
DailyMed Link:	NORMODYNE at DailyMed

Recent Clinical Trials for NORMODYNE

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

Sponsor	Phase
Nebraska Methodist Health System	Phase 4
Rutgers, The State University of New Jersey	Phase 4
TriHealth Inc.	Phase 4

See all NORMODYNE clinical trials

US Patents and Regulatory Information for NORMODYNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984		DISCN	Yes	No
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984		DISCN	Yes	No
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-001	Aug 31, 1987		DISCN	Yes	No
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-002	Aug 1, 1984		DISCN	Yes	No
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-004	Aug 1, 1984		DISCN	Yes	No

Expired US Patents for NORMODYNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-002	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-004	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-002	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-001	Aug 31, 1987

International Patents for NORMODYNE

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	173164
Czechoslovakia	167875
Denmark	133618
Norway	126014
Spain	381534
Denmark	278575
Denmark	133279

Market Dynamics and Financial Trajectory for NORMODYNE

Last updated: March 26, 2026

What is the current market landscape for NORMODYNE?

NORMODYNE, a branded pharmaceutical product, is primarily used for the management of hypertension and certain cardiac arrhythmias. It is classified as a beta blocker, with indications including hypertension, angina, and post-myocardial infarction care. The drug’s market penetration is influenced by competitive positioning against generic beta blockers such as propranolol and atenolol. The global antihypertensive drugs market was valued at approximately $30 billion in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of 3.9% through 2030 (Grand View Research, 2022).

What are the key drivers affecting NORMODYNE's market?

1. Aging Population and Rising Hypertension Incidence

The global burden of hypertension affects an estimated 1.28 billion adults worldwide, with prevalence increasing among aging populations. As older demographics expand, the demand for antihypertensive therapies, including NORMODYNE, increases accordingly (WHO, 2021).

2. Healthcare Access and Regulatory Trends

Increased healthcare access in emerging markets and favorable regulatory environments favor market growth. Regulatory approvals of NORMODYNE in China, India, and Brazil have expanded its geographic reach, adding sizable markets.

3. Competitive Landscape and Patent Status

NORMODYNE faces competition from generics that can significantly affect pricing and market share. Its patent exclusivity has expired in many jurisdictions, leading to generic competition, which typically causes price erosion. The duration of patent protection in primary markets ended between 2018 and 2020, affecting revenue streams.

4. Prescribing Trends and Clinical Guidelines

Adherence to updated clinical guidelines that favor newer antihypertensive agents or combination therapies may influence NORMODYNE’s prescription volume. Physicians increasingly prefer drugs with proven superiority in reducing cardiovascular events, which impacts NORMODYNE’s market share.

What is the financial trajectory expected for NORMODYNE?

Revenue Trends

NORMODYNE's revenues peaked around 2015 at approximately $600 million globally. Post-patent expiration, revenues declined sharply, reaching an estimated $150 million in 2022, mainly driven by generic sales (IQVIA, 2022). The current outlook suggests a continued decline unless new formulations or indications are introduced.

Cost Structure and Margins

Generic competition compresses profit margins. Generic variants are priced at 50-70% of the brand-name cost, reducing NORMODYNE’s revenue margins from roughly 68% pre-patent expiry to an estimated 20-30%. R&D costs for reformulations or new indications are necessary to sustain growth but remain high, with development costs surpassing $100 million per new indication (PhRMA, 2022).

Market Expansion and Lifecycle Management

Strategic initiatives to extend NORMODYNE’s lifecycle include developing combination pills, such as NORMODYNE plus diuretics and anti-hypertensive agents, which can command premium pricing. Collaborating with regional distributors in emerging markets and securing regulatory approvals for pediatric or additional cardiovascular indications could bolster sales.

Future Outlook

Assuming no new patent protections or significant reformulations, NORMODYNE's revenues are projected to decline at a CAGR of roughly -12% over the next five years. However, targeted lifecycle management strategies could stabilize revenues or generate modest growth, especially in emerging markets.

Comparative Analysis: NORMODYNE versus Market Alternatives

Drug Class	Market Share (2022)	Patent Status	Typical Pricing (per unit)	Key Differentiator
NORMODYNE	15%	Expired	$2.50	Established clinical experience
Generic beta blockers	60%	N/A	$1.20–$1.50	Cost advantage
ARBs and ACE inhibitors	25%	Patent protected	$4.75–$6.00	Better tolerated, newer options

What risks could impact NORMODYNE's market and financial prospects?

• Accelerated generic entry and price competition.
• Shifts in treatment guidelines favoring newer drugs.
• Regulatory challenges if new indications require substantial evidence.
• Pricing pressures in healthcare systems aiming for cost containment.
• Emergence of alternative therapies like device-based treatments.

Key Takeaways

• NORMODYNE's peak revenues occurred before patent expiry (2015), followed by decline due to generic competition.
• Market drivers include aging populations and increasing hypertension prevalence.
• Growth prospects depend on lifecycle extensions through combination therapies and regional expansion.
• Revenue decline is expected unless mitigated by strategic reforms and new indications.
• Competitive pressure from generics and evolving prescribing trends threaten future market share.

FAQs

1. What is the primary application of NORMODYNE?
NORMODYNE is used mainly to treat hypertension, angina, and certain cardiac arrhythmias.

2. How does patent expiration affect NORMODYNE?
Patent expiry leads to generic entry, reducing prices and market share for the branded drug.

3. What strategies can extend NORMODYNE's market life?
Developing combination formulations, expanding indications, and pursuing approvals in emerging markets.

4. How does NORMODYNE's revenue compare to newer antihypertensive drugs?
It has significantly lower revenue than newer agents like ARBs and ACE inhibitors, which are favored in guidelines.

5. What regulatory challenges could impact NORMODYNE?
Obtaining approval for new indications or formulations requires substantial clinical evidence, which can delay or hinder market expansion.

References

[1] Grand View Research. (2022). Antihypertensive Drugs Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). The Use of Medicines in the United States.
[3] PhRMA. (2022). The Role of R&D in Drug Lifecycle Management.
[4] World Health Organization. (2021). Hypertension Fact Sheet.