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:	4,168
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
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-004	Feb 2, 1995		DISCN	Yes	No
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-001	Feb 2, 1995		DISCN	Yes	No
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-007	Jan 2, 2008	AB	RX	Yes	Yes
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-003	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	020356-006	Jan 2, 2008	5,626,874
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-005	Jan 2, 2008	5,626,874
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-007	Jan 2, 2008	5,422,123
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-006	Jan 2, 2008	5,422,123
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-008	Jan 2, 2008	5,422,123
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-004	Feb 2, 1995	4,703,038
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-002	Feb 2, 1995	4,703,038

International Patents for SULAR

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

Country	Patent Number	Title	Estimated Expiration
Spain	2166769
Greece	852493
Denmark	0656204
Hungary	T40331
Germany	3870338
Spain	547931
Japan	H06172162	TABLET PROVIDED WITH RELEASE OF ACTIVE SUBSTANCE WITH CONTROLLED SPEED

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

Last updated: July 29, 2025

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Introduction

SULAR, a brand name for nifedipine extended-release (ER), is a calcium channel blocker widely prescribed for hypertension and angina. Its market presence has historically been substantial, owing to its efficacy, cost-effectiveness, and longstanding clinical use. However, the evolving pharmaceutical landscape, patent expirations, generic entry, and regulatory shifts significantly influence its market dynamics and financial trajectory.

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Pharmaceutical Profile and Market Position

Nifedipine ER, marketed under SULAR among other brands, has been a staple in cardiovascular therapeutics since FDA approval. Its mechanism involves calcium channel blockade, leading to vasodilation and decreased blood pressure. The drug’s once-daily dosing enhances patient compliance, reinforcing its market utility.

Market dominance benefited from a combination of clinical familiarity, physician preference, and relatively low cost. However, the patent protection for SULAR has long expired—though the original formulation had patent protections, generics entered the market decades ago, significantly diminishing profitability for the branded drug [1].

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Market Dynamics

1. Patent Landscape and Generic Competition

The core driver of market change is extensive generic proliferation. Once exclusivity ends, generic manufacturers produce nifedipine ER at markedly reduced costs, reducing branded drug sales. According to IQVIA data, generic nifedipine ER accounts for the majority of prescriptions in the hypertension segment [2].

Impact: The branded SULAR faces stiff price competition and declining market share, typical for legacy drugs post-generic entry. The decline is accelerated by healthcare payers favoring generics to control costs.

2. Regulatory and Patent-Related Developments

While the original patents have expired, there have been attempts at regulatory exclusivities and secondary patents aimed at extending market life, such as formulation or delivery method patents. However, courts have often invalidated such patents, further opening the market to generics [3].

3. Therapeutic Guidelines and Prescriber Preferences

Current hypertension management guidelines endorse multiple agents, including nifedipine ER. Prescriber inertia favors existing efficacious drugs, though newer calcium channel blockers and combination therapies gain favor due to improved side effect profiles and newer formulations [4].

Implication: The steady but saturated market constrains potential growth for SULAR without significant innovation or brand differentiation.

4. Market Penetration and Geographic Factors

SULAR’s primary markets include the US, Europe, and emerging economies. While the US market is heavily genericized, emerging markets still rely on branded formulations due to patent protections or supply chain considerations [5].

Note: Regulatory hurdles, pricing regulations, and healthcare infrastructure differences influence sales trajectories across territories.

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Financial Trajectory Analysis

1. Sales Trends

Given the recent high generic penetration, SULAR’s branded sales have seen a consistent decline. Data from IQVIA indicate that similar legacy drugs have experienced an 80-90% reduction in branded revenue over the past decade [2].

Forecast: The continued erosion is expected to persist unless the brand introduces reformulations, biosimilars, or novel delivery mechanisms.

2. Manufacturing and Cost Structures

The manufacturing costs for generic nifedipine ER are significantly lower than the branded counterpart. As market share diminishes, profit margins for SULAR decline further unless cost-reduction strategies or licensing deals are adopted.

3. Licensing and Strategic Partnerships

Some pharmaceutical companies pursue licensing arrangements to extend market life—by developing combination products or reformulations. Such strategies can provide incremental revenue but often require substantial investment and regulatory approval cycles.

4. Impact of Healthcare Policy and Pricing Reforms

Healthcare payers’ push for cost containment favors generics, leading to restricted reimbursement for branded drugs. Price caps and formulary restrictions further depress revenues.

Projections: Without innovation, the financial trajectory of SULAR will be characterized by declining sales and profitability, approaching negligible levels in matured markets.

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Key Market Drivers and Barriers

Drivers	Barriers
Cost-effective generic competition	Patent expirations and patent challenges
Established clinical efficacy	Physician preference shifting to newer agents
Wide insurance coverage	Regulatory hurdles for reformulations
Acceptable safety profile	Pricing and formulary restrictions in developed markets

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Future Outlook and Strategic Considerations

1. Potential for Reformulation and New Indications

Innovation in delivery systems (e.g., controlled-release, transdermal patches) could rejuvenate interest. For instance, reformulating SULAR into a patch might improve adherence and expand market appeal.

2. Biosimilars and Combination Therapies

Though less common for small molecules like nifedipine, combination products with antihypertensives might carve niche markets.

3. Market Exit or Acquisition

Pharmaceutical companies facing declining revenues may opt to divest or discontinue SULAR production. Conversely, some may acquire rights for niche markets or emerging economies.

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Conclusion

The market dynamics for SULAR are emblematic of legacy drugs in a highly competitive, generic-dominated landscape. With patent expirations, the decline in sales and profitability is inevitable unless the manufacturer invests, innovates, or pivots toward niche markets. The financial trajectory indicates a downward trend, emphasizing the importance for stakeholders to explore reformulation, strategic licensing, or market diversification to sustain value.

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Key Takeaways

• Generic competition dominates, significantly reducing SULAR’s revenue prospects in mature markets.
• Patent expirations have historically precipitated substantial declines for branded nifedipine ER.
• Market saturation and prescriber preferences favor newer agents, challenging SULAR’s relevance without innovation.
• Cost efficiencies in manufacturing lower barrier entry for generics but accelerate erosion of branded sales.
• Future growth avenues depend on reformulation, niche market targeting, or licensing strategies, given current market pressures.

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FAQs

Q1: What is the primary factor influencing SULAR’s declining sales?
A: The widespread availability of generic nifedipine ER and patent expirations have led to intense price competition, diminishing branded sales.

Q2: Are there any ongoing efforts to reformulate SULAR or develop new indications?
A: While no major reformulations are publicly announced, innovation strategies like transdermal patches and combining with other antihypertensives are potential avenues for extending its market life.

Q3: How do healthcare policies impact SULAR’s market?
A: Policies promoting generic substitution and cost containment in healthcare systems favor generics, placing branded drugs like SULAR under pressure to reduce prices or exit markets.

Q4: What strategies can manufacturers adopt to sustain revenue from legacy drugs like SULAR?
A: Investing in reformulation, seeking new indications, exploring niche markets, or licensing can help extend the product’s relevance and profitability.

Q5: How significant is the role of emerging markets for SULAR’s future?
A: Emerging markets representing less saturated territories still value branded formulations; thus, they may offer limited growth opportunities if patent protections or supply chain factors favor branded drugs.

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References

[1] US FDA Database. Nifedipine patents and exclusivity data.

[2] IQVIA. Prescription market analysis reports, 2022.

[3] Court rulings on secondary patents for calcium channel blockers, 2018-2020.

[4] Guidelines for hypertension management, American College of Cardiology, 2022.

[5] World Health Organization reports on pharmaceutical markets in emerging economies, 2021.