SULAR Drug Patent Profile

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

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

The generic ingredient in SULAR is nisoldipine. There are eight drug master file entries for this compound. Two 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 AMTA on April 10^th, 2023.

Summary for SULAR

US Patents:	0
Applicants:	1
NDAs:	1

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
Azurity	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-008	Jan 2, 2008	AB	RX	Yes	Yes
Azurity	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-005	Jan 2, 2008		RX	Yes	Yes
Azurity	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-002	Feb 2, 1995		DISCN	Yes	No
Azurity	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-004	Feb 2, 1995		DISCN	Yes	No
Azurity	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-001	Feb 2, 1995		DISCN	Yes	No
Azurity	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-007	Jan 2, 2008	AB	RX	Yes	Yes
Azurity	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-003	Feb 2, 1995		DISCN	Yes	No

International Patents for SULAR

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

Country	Patent Number	Title	Estimated Expiration
Austria	44650
Australia	4840085
Canada	1251733	COMBINAISON DE DIHYDROPYRIDINES AVEC DES INHIBITEURS DE L'ENZYME DE CONVERSION DE L'ANGIOTENSINE ET UTILISATION COMME MEDICAMENTS (COMBINATION OF DIHYDROPYRIDINES WITH ACE INHIBITORS AND THEIR USE IN MEDICAMENTS)
German Democratic Republic	239525	VERFAHREN ZUR HERSTELLUNG EINER KOMBINATION VON DIHYDROPYRIDENEN MIT ACE-HEMMERN
Germany	3437917
Germany	3571550
Denmark	473585

Last updated: February 3, 2026

mmary
SULAR (nisoldipine) is a calcium channel blocker approved primarily for hypertension and angina. Its market has declined due to newer therapies and patent expirations but remains relevant in specific niches. Investment prospects depend on regulatory status, patent landscapes, competitive positioning, and potential for new indications or formulations.

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What Is the Current Market for SULAR?

Market size and sales
SULAR sales peaked before patent expiration, with global annual revenues estimated at approximately $84 million in 2014. Since then, sales declined significantly, especially in the U.S. after generic entry in 2018. The drug continues to see prescriptions mainly in legacy markets and for patients intolerant to newer drugs.

Patents and exclusivity
The original patent expired in the U.S. in 2018. There are no active formulation patents post-expiry, allowing generics to capture market share. The absence of new patents limits direct patent-driven revenue growth.

Regulatory landscape
SULAR retained FDA approval, but new labeling or indications are unlikely without additional clinical research. Off-label use is constrained by market trends favoring newer calcium channel blockers.

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How Does SULAR Fit in Competitive Dynamics?

Generic competition
Multiple generic companies manufacture nisoldipine. The price erosion post-patent expiry lowered revenue margins substantially. The generic market share in the U.S. is dominant, with branded sales shrinking.

Pipeline and development status
No significant ongoing clinical trials or development programs target SULAR or nisoldipine. Repurposing for novel indications has not gained traction.

Alternative therapies
Newer drugs like amlodipine, similarly effective and with longer half-lives, have replaced SULAR in many markets. Brand loyalty and formulary preferences favor these newer agents.

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What Are the Investment Fundamentals?

Aspect	Details
Revenue trends	Steep decline post-2018; residual sales mainly from legacy markets.
Profitability	Marginal due to low profit margins on generics and generic price competition.
Market growth prospects	Limited; forecasted decline; no new indications or formulations announced.
Regulatory risk	Low for existing approval; high for seeking new indications or formulations.
Intellectual property	Patent cliff resulted in loss of exclusivity; no new patents filed for formulations.
Market positioning	Declining; limited capacity for reversal without innovation.

Investment implications
SULAR’s fundamental profile indicates a mature, declining asset with no immediate growth catalysts. Patents expired, sales eroded by generics, and no active pipeline suggest that investing in SULAR directly carries limited upside.

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What Are Strategic Opportunities or Risks?

Opportunities

• Potential niche markets where SULAR remains standard therapy.
• Lifecycle management through new formulations or delivery methods, but no current plans are announced.

Risks

• Further erosion of market share due to generic competition.
• Adoption of newer, more tolerable drugs replacing SULAR for hypertension and angina.
• Regulatory changes impacting older drugs’ status.

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What Are Key Takeaways?

• SULAR experienced peak revenues prior to 2018, followed by sharp decline post-generic entry.
• Its patent expiration and the arrival of cheaper generics most directly contributed to revenue erosion.
• The absence of ongoing clinical development diminishes upside prospects; the asset remains mature.
• Investment in SULAR itself offers limited returns unless coupled with niche market opportunities or development prospects.
• Market dynamics favor newer, more convenient, or better-tolerated medications, further constraining SULAR’s future.

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FAQs

1. Is SULAR still a profitable drug?
Sales have declined sharply after patent expiration, and profitability is limited to residual legacy markets. No significant margins are expected without new formulations or indications.

2. Are there plans to reformulate or repurpose SULAR?
No publicly known plans; the lack of ongoing clinical trials or development initiatives limits prospects for lifecycle extension.

3. How does SULAR compare to other calcium channel blockers?
It is less favored due to its dosing schedule and side effect profile compared to drugs like amlodipine or nifedipine, which have longer half-lives and more convenient dosing.

4. What are the main regulatory risks for SULAR?
Existing approvals are stable; however, new indications or formulations would require additional clinical trials, which are unlikely given the market landscape.

5. Should investors consider SULAR for a portfolio?
Given its declining sales and limited innovation, only specialist or niche-market situations could justify investment, which remains unlikely.

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Sources
[1] IMS Health (2014)
[2] FDA Labeling for nisoldipine (SULAR)
[3] Market Research Reports (2019-2022)
[4] Company Financial Disclosures