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Last Updated: December 23, 2024

SULAR Drug Patent Profile


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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 25th, 2008.

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Summary for SULAR
Drug patent expirations by year for SULAR
Drug Prices for SULAR

See drug prices for SULAR

Pharmacology for SULAR
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-005 Jan 2, 2008 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-002 Feb 2, 1995 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-004 Feb 2, 1995 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-001 Feb 2, 1995 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SULAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-002 Feb 2, 1995 ⤷  Subscribe ⤷  Subscribe
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-004 Feb 2, 1995 ⤷  Subscribe ⤷  Subscribe
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-008 Jan 2, 2008 ⤷  Subscribe ⤷  Subscribe
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-003 Feb 2, 1995 ⤷  Subscribe ⤷  Subscribe
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-006 Jan 2, 2008 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SULAR

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

Country Patent Number Title Estimated Expiration
Germany 3571550 ⤷  Subscribe
Greece 852493 ⤷  Subscribe
Japan 2955524 ⤷  Subscribe
Hungary 194053 PROCESS FOR PREPARING PHARMACEUTICAL COMPOSITIONS CONTAINING A COMBINATION OF DIHIDRO-PYRIDINES AND ACE-INHIBITORS ⤷  Subscribe
Ireland 881916 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

SULAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug SULAR

Introduction

SULAR, also known as nisoldipine, is a dihydropyridine calcium channel blocker used primarily to treat hypertension. To understand the market dynamics and financial trajectory of SULAR, it is crucial to analyze various factors including its launch, pricing trends, competition, and overall market conditions.

Launch and Initial Market Impact

SULAR was introduced in the mid-1990s, a period marked by significant changes in the pharmaceutical market. During this time, the launch prices of new drugs were often influenced by the existing market landscape. For instance, drugs in the calcium channel blocker (CCB) category, like SULAR, typically entered the market at prices competitive with or slightly discounted from the incumbent drugs[1].

Launch Price Analysis

When SULAR was launched in February 1996, it entered a market already populated by other CCBs. The launch price of SULAR was compared to the prices of other drugs in its subclass. According to the ASPE report, SULAR (nisoldipine 20 mg) was launched with a price increase of 37.7% relative to the weighted average price of the incumbents in the CCB subclass. However, it was still discounted significantly relative to the price leader in the category[1].

Pricing Trends Over Time

The pricing of SULAR has been subject to various market forces and regulatory influences.

Real Price Changes

From 1995 to 1999, the real prices for many pharmaceuticals, including CCBs, experienced declines. For SULAR, the real price change was 67.9% over this period, indicating a significant increase in nominal terms but a more modest change when adjusted for inflation[1].

Rebates and Discounts

The pharmaceutical industry, including drugs like SULAR, has seen fluctuations in rebates and discounts. In the late 1990s, rebates returned to levels similar to those in the early 1990s due to stricter access and utilization controls implemented by Pharmacy Benefit Managers (PBMs)[1].

Competition in the CCB Market

The CCB market is highly competitive, with several drugs available for treating hypertension.

Market Share and Competitors

SULAR competes with other CCBs such as Posicor (mibefradil) and Diovan (valsartan), an angiotensin-receptor blocker (ARB) that also treats hypertension. The competition in this market segment has driven pricing strategies, with new entrants often launching at prices competitive with or slightly above existing drugs[1].

Financial Trajectory

The financial performance of SULAR is influenced by several factors, including sales volume, pricing, and market share.

Sales and Revenue

While specific sales data for SULAR is not provided in the sources, the overall trend in pharmaceutical spending can give insights. The spending on pharmaceuticals has been increasing, driven by factors such as new drug approvals, increased utilization, and price increases. For example, in 2023, overall pharmaceutical expenditures in the US grew by 13.6%, with utilization, new drugs, and price increases contributing to this growth[3].

Impact of Generic Competition

The introduction of generic versions of drugs can significantly impact the financial trajectory of brand-name drugs like SULAR. Generic competition often leads to a decline in sales and revenue for the brand-name drug as generics are typically priced lower. However, SULAR's specific generic competition timeline and impact are not detailed in the provided sources.

Regulatory and Policy Influences

Regulatory and policy changes can also affect the financial trajectory of pharmaceuticals.

FDA Approvals and Patent Expirations

New drug approvals and patent expirations are critical factors. While SULAR's patent status is not explicitly mentioned, the general trend is that drugs face significant competition upon patent expiration. New policies or legislation, such as those affecting pricing or reimbursement, can also influence the market dynamics[3].

Market Projections

Looking ahead, the pharmaceutical market, including drugs like SULAR, is expected to continue growing.

Future Spending Projections

For 2024, overall prescription drug spending is projected to increase by 10.0% to 12.0%, with clinics and hospitals anticipating an 11.0% to 13.0% increase. Specialty, endocrine, and cancer drugs are expected to drive these expenditures, although the impact on specific drugs like SULAR will depend on various market and regulatory factors[3].

Key Takeaways

  • Launch Pricing: SULAR entered the market with a competitive pricing strategy relative to other CCBs.
  • Pricing Trends: Real prices for CCBs, including SULAR, have seen fluctuations over time, influenced by rebates and discounts.
  • Competition: The CCB market is highly competitive, with SULAR competing against other drugs like Posicor and Diovan.
  • Financial Trajectory: The financial performance of SULAR is influenced by sales volume, pricing, and market share, with potential impacts from generic competition and regulatory changes.
  • Market Projections: The pharmaceutical market is expected to grow, with specialty and other high-cost drugs driving expenditures.

FAQs

What is SULAR used for?

SULAR (nisoldipine) is used primarily to treat hypertension by reducing systemic vascular resistance and blood pressure.

When was SULAR launched?

SULAR was launched in February 1996.

How did SULAR's launch price compare to other drugs in its class?

SULAR was launched with a price increase of 37.7% relative to the weighted average price of the incumbents in the CCB subclass but was discounted significantly relative to the price leader[1].

What factors influence the pricing of SULAR?

The pricing of SULAR is influenced by rebates, discounts, competition from other CCBs, and regulatory changes.

How is the pharmaceutical market expected to grow in 2024?

The overall prescription drug spending is projected to increase by 10.0% to 12.0% in 2024, driven by factors such as new drug approvals, increased utilization, and price increases[3].

What impact does generic competition have on brand-name drugs like SULAR?

Generic competition typically leads to a decline in sales and revenue for brand-name drugs as generics are priced lower.

Sources

  1. Price Trends for Prescription: Pharmaceuticals: 1995-1999 - ASPE
  2. Fiscal Year 2022 Budget Information - Congressional Justification for National Institute on Drug Abuse
  3. National trends in prescription drug expenditures and projections for 2024 - PubMed
  4. SULAR (nisoldipine) - FDA Label
  5. Medicines Use and Spending Shifts - Vermont Legislature

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