SULAR Drug Patent Profile

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

Sular is a drug marketed by Covis and is included in one NDA.

The generic ingredient in SULAR is nisoldipine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sular

A generic version of SULAR was approved as nisoldipine by MYLAN on July 25^th, 2008.

Summary for SULAR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	93
Patent Applications:	6,188
Drug Prices:	Drug price information for SULAR
What excipients (inactive ingredients) are in SULAR?	SULAR excipients list
DailyMed Link:	SULAR at DailyMed

See drug prices for SULAR

Pharmacology for SULAR

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists
Physiological Effect	Decreased Blood Pressure

Paragraph IV (Patent) Challenges for SULAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SULAR	Extended-release Tablets	nisoldipine	8.5 mg and 17 mg	020356	1	2009-03-02
SULAR	Extended-release Tablets	nisoldipine	25.5 mg and 34 mg	020356	1	2008-11-28
SULAR	Extended-release Tablets	nisoldipine	20 mg and 30 mg	020356	1	2007-11-07
SULAR	Extended-release Tablets	nisoldipine	40 mg	020356	1	2007-06-11

US Patents and Regulatory Information for SULAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-008	Jan 2, 2008	AB	RX	Yes	Yes
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-005	Jan 2, 2008	AB	RX	Yes	Yes
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-002	Feb 2, 1995		DISCN	Yes	No

Expired US Patents for SULAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-004	Feb 2, 1995	4,892,741
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-003	Feb 2, 1995	4,892,741
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-008	Jan 2, 2008	5,422,123

International Patents for SULAR

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

Country	Patent Number	Title	Estimated Expiration
Spain	2085316
Austria	75142
Italy	8922694

Market Dynamics and Financial Trajectory for SULAR (Nifedipine Extended-Release)

Last updated: February 11, 2026

Overview

SULAR (Nifedipine Extended-Release) is a calcium channel blocker indicated for hypertension and angina. It holds a legacy position within the cardiovascular therapeutics market, but its market presence has declined due to generic competition and evolving treatment guidelines.

Market Size and Trends

The global calcium channel blocker market was valued at approximately $4.5 billion in 2022. It exhibits a compound annual growth rate (CAGR) of around 4% projected through to 2030. SULAR, which once occupied a significant share, has seen its market share decrease with increasing generic entries.

• Sales Data: SULAR's peak sales in the U.S. reached approximately $300 million in 2005 before reductions due to patent expiry and generic erosion.
• Patent Landscape: The original patent on SULAR expired in 2008. Multiple generics entered soon after, eroding formulary exclusivity.
• Market Decline: Current estimates place SULAR’s annual sales below $50 million in the U.S., with similar trends in Europe.

Competitive Environment

• Generic Competition: Over 10 generic nifedipine products are marketed, leading to substantial price competition.
• Brand Positioning: SULAR's branded sales have fallen as physicians shift toward generics, which are covered broadly by insurers.
• Alternative Therapies: Newer antihypertensive agents, such as angiotensin receptor blockers (ARBs) and ACE inhibitors, have gained favor, reducing reliance on traditional calcium channel blockers.

Regulatory and Patent Considerations

• Orphan Drug Status: Not granted for SULAR, limiting exclusive marketing opportunities.
• New Formulation Opportunities: Attempts to develop extended-release formulations with improved bioavailability or reduced side effects do not appear to have advanced significantly recently.
• Potential patent Misses: No recent patents have been filed for SULAR-specific formulations, restricting new patent protections.

Financial Trajectory

• Revenue Projection: Given current market conditions, sales are expected to decline 10-15% annually due to generic penetration and declining prescribing rates.

Year	Estimated Sales (USD millions)
2022	45
2023	38.3
2024	32.5
2025	27.6
2026	23.4

• Profitability: Margins are minimal due to low brand premiums and high generic price competition. R&D investments are unlikely justified in the current market.

Key Market Drivers

• Older Population: Increasing prevalence of hypertension supports continued demand for generic nifedipine.
• Market Saturation: High generic availability limits pricing power.
• Physician Preference: Preference for newer agents with better side-effect profiles influences prescribing behavior away from SULAR.

Barriers to Growth

• Market Saturation: Near-complete generic market penetration limits growth opportunities.
• Limited Differentiation: Lack of formulation innovation hampers competitive advantage.
• Pricing Pressure: Insurers favor low-cost generics, reducing revenue potential.

Potential Strategic Fits

• Line Extension: Limited due to patent expiration.
• Market Exit: Likely the most practical course given declining revenues and minimal investment appeal.
• Repositioning: No clear opportunities for new indications or formulations at this stage.

Summary

SULAR’s market position is characterized by significant decline. The product’s revenue has diminished sharply over the past decade due to patent expiry and generic competition. Future revenues are expected to continue shrinking, making sustained profitability unlikely without reformulation or new indications.

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Key Takeaways

• SULAR entered a mature, highly competitive segment with existing generics dominating sales.
• The product’s revenue has fallen by approximately 85% since peak years.
• No recent patent protections or formulation innovations are evident to revive its market standing.
• Market dynamics favor low-cost generics, pressuring branded product margins.
• Continued declines forecasted, with minimal strategic upside short-term.

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FAQs

1. Why did SULAR’s sales decline so sharply after 2008?
Expiration of patents led to generic entry, pricing competition, and loss of brand exclusivity, reducing sales dramatically.

2. Are there any new formulations or patents that could revitalize SULAR?
No significant recent patents or reformulations are documented, limiting opportunities for repositioning.

3. What therapies are replacing SULAR in hypertension treatment?
ARBs, ACE inhibitors, and newer calcium channel blockers with improved profiles are increasingly prescribed.

4. Is there a potential market for SULAR in emerging markets?
Possible; however, generic availability and pricing pressures are similarly impactful, limiting growth prospects.

5. Would acquiring or licensing SULAR be financially viable?
Unlikely, given current market trends and projected declining revenues. The main value might exist in legacy sales or for portfolio balance rather than profit generation.

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Sources

[1] GlobalData, 2022. Calcium Channel Blocker Market Report.
[2] IQVIA, 2022. U.S. Prescription Drug Sales Data.
[3] U.S. Patent and Trademark Office. Patent status on nifedipine formulations.
[4] EvaluatePharma, 2023. 2023 Pharmaceutical Market Forecast.