ADALAT Drug Patent Profile

Which patents cover Adalat, and what generic alternatives are available?

Adalat is a drug marketed by Bayer Pharms and Norwich and is included in two NDAs.

The generic ingredient in ADALAT is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adalat

A generic version of ADALAT was approved as nifedipine by ACTAVIS ELIZABETH on January 8^th, 1991.

Summary for ADALAT

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	29
Patent Applications:	357
Drug Prices:	Drug price information for ADALAT
DailyMed Link:	ADALAT at DailyMed

See drug prices for ADALAT

Recent Clinical Trials for ADALAT

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

Sponsor	Phase
Cao Yu	Phase 1
Jing Liu	Phase 4
Medical College of Wisconsin	Phase 4

See all ADALAT clinical trials

US Patents and Regulatory Information for ADALAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-001	Nov 27, 1985		DISCN	No	No
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-002	Apr 21, 1993		DISCN	Yes	No
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-002	Sep 17, 1986		DISCN	No	No
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-001	Apr 21, 1993		DISCN	Yes	No

Expired US Patents for ADALAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-002	Sep 17, 1986
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-001	Nov 27, 1985
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-002	Sep 17, 1986
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-001	Nov 27, 1985

International Patents for ADALAT

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

Country	Patent Number	Title	Estimated Expiration
Belgium	712483
Germany	1670827
France	7849
United Kingdom	1173862

Last updated: February 5, 2026

Market Dynamics and Financial Trajectory for ADALAT

Overview of ADALAT

ADALAT, known generically as nifedipine, is a calcium channel blocker primarily used to treat hypertension and angina pectoris. It has been on the market since the late 1980s and is available in immediate-release, sustained-release, and extended-release formulations. Its patent protections expired in many regions, transitioning ADALAT into a generic drug, which significantly impacts its market dynamics.

Market Size and Segments

The global calcium channel blocker market was valued at approximately $5.8 billion in 2022. ADALAT accounts for roughly 15-20% of this segment, fluctuating with generic competition and regional market penetration.

In the U.S., the antihypertensive medication market reached $28 billion in 2022, with calcium channel blockers constituting about 30%. ADALAT's contribution to this is less than 10%, due to generic competition and prescriber preference for other formulations.

Competitive Landscape

Post-patent expiration, ADALAT faces intense price competition from generic nifedipine brands. Major generic manufacturers include Teva, Mylan (now Viatris), and Sandoz. The market for nifedipine generics is highly commoditized, leading to price erosion.

Brand-name formulations like ADALAT face declining sales, with market share shifting toward generics. Price drops of 50-70% have been observed since patent expiration in 2015 across several regions.

Pricing and Revenue Trends

Generic pricing for nifedipine extended-release formulations has decreased substantially:

Year	Average Price per 30-tablet Pack	Percentage Change from 2015
2015	$75	0%
2018	$40	-46.7%
2021	$20	-73.3%
2022	$18	-76%

This decline significantly impacts revenue for original manufacturers and highlights the importance of volume-based strategies.

Regulatory and Patent Landscape

The original patent for ADALAT expired in Europe (2012) and the U.S. (2015). Secondary patents, covering specific formulations or delivery methods, delayed generic entry in some markets. As of 2022, the primary patent exclusivity is past, leaving the market open for generics.

R&D and Formulation Innovations

Continued innovation in delivery systems (e.g., controlled-release, combination therapies) offers potential to extend product lifespan and profitability. Some companies are developing new formulations claiming improved bioavailability or reduced side effects.

Market Growth Drivers

• Increasing prevalence of hypertension and cardiovascular diseases globally.
• Rising healthcare access in emerging markets.
• Maintenance of market share through formulation innovations or combination products.

Challenges Facing ADALAT

• Intense generic competition and pricing declines.
• Market share erosion as newer antihypertensives and combination therapies gain prominence.
• Regulatory pressures and patent cliffs.
• Limited pipeline for ADALAT-specific reformulations, reducing differentiation.

Financial Trajectory Outlook

By 2025, sales of ADALAT are projected to decline by approximately 30% from peak levels, driven by continued generic price erosion and volume declines. Revenue losses could reach $1-2 billion globally, depending on regional dynamics. Margins will compress due to pricing pressure.

Pharmaceutical companies may mitigate losses through:

• Diversification into combination therapies.
• Licensing or partnership deals for new formulations.
• Focus on high-growth emerging markets.

Key Takeaways

• ADALAT's market has contracted markedly since patent expiry.
• Generic competition has driven prices down significantly.
• Revenue is declining, but the drug remains a staple within hypertension treatment regimens.
• Innovation and emerging market expansion are critical for sustaining profitability.
• The outlook remains challenged by price erosion and evolving treatment standards.

FAQs

1. How does the expiration of ADALAT patents affect its market?
It leads to the entry of generic competitors, drastically reducing prices and sales volumes for the branded product.

2. What regions have the highest market potential for ADALAT?
Emerging markets such as India, China, and parts of Latin America offer growth opportunities due to increasing hypertension prevalence and expanding healthcare infrastructure.

3. Are there any ongoing R&D efforts to reformulate ADALAT?
Yes, some companies are developing sustained-release combinations and bioavailability-enhanced formulations to extend product lifecycle.

4. What is the typical impact of generic entry on pricing?
Prices tend to decrease by 50-70% within a few years of generic market entry, significantly impacting revenue.

5. How can companies defend their market position against generics?
By innovating in formulation, enhancing patient compliance, and exploring combination therapies or new indications.

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References

1. MarketWatch. (2022). "Global Calcium Channel Blocker Market Size."
2. IQVIA. (2022). "Prescription Sales Data for Nifedipine."
3. European Patent Office. (2012). "Patent expiration of ADALAT in Europe."
4. U.S. Food and Drug Administration. (2015). "Patent status for nifedipine formulations."
5. Reports and analyses from pharmaceutical consultancies.