ADALAT CC Drug Patent Profile

When do Adalat Cc patents expire, and what generic alternatives are available?

Adalat Cc is a drug marketed by Norwich and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adalat Cc

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

Summary for ADALAT CC

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ADALAT CC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-001	Apr 21, 1993		DISCN	Yes	No
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-002	Apr 21, 1993		DISCN	Yes	No
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-003	Apr 21, 1993		DISCN	Yes	No

International Patents for ADALAT CC

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

Country	Patent Number	Title	Estimated Expiration
Argentina	226377	PROCEDIMIENTO PARA LA OBTENCION DE FORMULACIONES MEDICAMENTOSAS A BASE DE NIFEDIPINA
German Democratic Republic	201974	VERFAHREN ZUR HERSTELLUNG VON FESTEN ARZNEIZUBEREITUNGEN ENTHALTEND NIFEDIPIN
Israel	86827	PRESS COATED TABLETS CONTAINING DIHYDROPYRIDINES AND THEIR PREPARATION

Adalat CC: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Overview

Adalat CC, the sustained-release formulation of nifedipine, is indicated for angina and hypertension. Manufactured by Bayer AG, its global sales have shown moderate growth driven by hypertension prevalence and cardiovascular disease management. The drug's patent held until 2014 in the U.S., with generic versions now dominant, affecting revenue streams and investment potential.

Market Position and Competitive Landscape

• Market share: Once a leading calcium channel blocker (CCB), Adalat CC's market share has declined post-patent expiry.
• Generics: Introduced around 2014, generics have captured over 80% of U.S. prescriptions, significantly reducing Bayer's revenues.
• Key competitors: Other sustained-release CCBs like amlodipine and nifedipine variants from Teva, Mylan, and Sun Pharma, compete on price and formulation.

Market Dynamics

• Global hypertension prevalence: Estimated at 1.3 billion adults in 2020 (WHO), with drug therapy rates increasing in emerging markets.
• Regulatory actions: Recent FDA warnings about potential formulations' side effects have influenced prescribing trends.
• Pricing pressure: Heightened due to generic competition, forcing manufacturers to lower prices or shift focus to new formulations or indications.

Financial Trajectory

• Historical revenues: Bayer's sales of Adalat CC peaked before patent expiry, with 2013 figures around $300 million globally.
• Post-patent decline: Revenues declined sharply post-2014, with estimates of a 30-40% drop annually in generic-dominated markets.
• Research and development investments: Bayer has redirected R&D toward combination therapies and novel CCBs, impacting potential newer revenue streams from Adalat-like compounds.

Investment Outlook

• Current valuation: Bayer's cardiovascular segment accounts for approximately 15% of total revenue, influenced heavily by mature drugs like Adalat CC.
• Near-term prospects: Limited growth expected in mature markets owing to patent expirations and intense generic competition.
• Long-term prospects: Potential in expansion to niche indications (e.g., Raynaud's phenomenon) or lipid-lowering combination therapies, though these remain developmental.

Key Factors Influencing Financial Performance

Factor	Impact	Details
Patent expiry	Negative	Patent expiration led to revenue erosion from 2014 onward.
Generic competition	Negative	Over 80% of U.S. prescriptions by 2016.
Market expansion in emerging markets	Positive	Growing hypertension treatment populations.
New formulation or indication development	Potential positive	Could generate new revenue streams.

Conclusion

Adalat CC faces a declining revenue trajectory driven by patent expiration and generic entry. Continued investment in innovation and diversification into combination therapies may offer recovery opportunities but are not assured in the short term.

---

Key Takeaways

• Adalat CC's revenue has significantly declined due to patent expiration and generic competition.
• Market growth in hypertension globally offers potential for niche or expanded indications.
• Bayer's strategic shift toward developing new formulations and combination drugs influences long-term prospects.
• Competition pulls prices downward, pressure on profit margins persists.
• Future investment should focus on R&D pipelines or emerging markets for potential growth.

---

FAQs

1. What was the peak revenue year for Adalat CC before patent expiry?

   • 2013, with approximately $300 million globally.

2. How has generic competition affected Bayer’s revenues from Adalat CC?

   • Revenues declined by roughly 30-40% annually following patent expiry in 2014.

3. Are there any ongoing efforts to develop new formulations of nifedipine?

   • Bayer is exploring combination therapies and extended-release formulations to diversify revenue sources.

4. Which markets present growth opportunities for Adalat CC?

   • Emerging markets with rising hypertension prevalence, such as China and India.

5. What factors could reverse the revenue decline for Adalat CC?

   • Launch of new formulations, expanded indications, or strategic partnerships focusing on cardiovascular therapy.

References

[1] World Health Organization. (2022). Hypertension Fact Sheet.
[2] Bayer AG Financial Reports. (2013-2022).
[3] IMS Health Data. (2014-2022).
[4] U.S. Food and Drug Administration. (2016). Warning on Certain Nifedipine Formulations.