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Last Updated: December 22, 2024

CARTIA XT Drug Patent Profile


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Which patents cover Cartia Xt, and what generic alternatives are available?

Cartia Xt is a drug marketed by Actavis Labs Fl Inc and is included in one NDA.

The generic ingredient in CARTIA XT is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cartia Xt

A generic version of CARTIA XT was approved as diltiazem hydrochloride by TEVA on May 31st, 1995.

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SponsorPhase
The University of Hong KongPhase 4

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Pharmacology for CARTIA XT

US Patents and Regulatory Information for CARTIA XT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Fl Inc CARTIA XT diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074752-002 Jul 9, 1998 AB3 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Actavis Labs Fl Inc CARTIA XT diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074752-004 Jul 9, 1998 AB3 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Actavis Labs Fl Inc CARTIA XT diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074752-001 Jul 9, 1998 AB3 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Actavis Labs Fl Inc CARTIA XT diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074752-003 Jul 9, 1998 AB3 RX No 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

CARTIA XT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cartia XT

Introduction

Cartia XT, a generic version of the calcium channel blocker diltiazem, has been a significant player in the market for treating hypertension, chest pain, and certain heart rhythm disorders. This article delves into the market dynamics and financial trajectory of Cartia XT, highlighting its impact, pricing, and the legal battles that have shaped its market presence.

Mechanism of Action and Indications

Cartia XT, or diltiazem hydrochloride, belongs to the class of calcium channel blockers. It works by inhibiting the cellular influx of calcium ions, thereby relaxing blood vessels and reducing heart rate. This mechanism helps in treating hypertension, managing chronic stable angina, and alleviating angina due to coronary artery spasm[1][4].

Market Entry and Competition

The entry of Cartia XT into the market was marked by controversy. Andrx, the manufacturer, was prevented from marketing Cartia XT due to an illegal agreement with Hoechst (later Aventis), the manufacturer of the brand-name version, Cardizem CD. This agreement, which paid Andrx nearly $100 million to keep Cartia XT off the market, was eventually exposed and led to legal action by several state Attorneys General[5].

Financial Impact of Delayed Market Entry

The delayed entry of Cartia XT into the market had significant financial implications for consumers and the healthcare system. During the period when Cartia XT was kept off the market, consumers were forced to purchase the more expensive brand-name version, Cardizem CD. This resulted in artificially high prices, with Hoechst earning over $700 million from Cardizem CD sales in 1997 alone[5].

Pricing and Cost Savings

Once Cartia XT was allowed to enter the market, it offered substantial cost savings to consumers. The price for Cartia XT is significantly lower than its brand-name counterpart. For example, a 90-capsule supply of Cartia XT (120 mg/24 hours) can cost around $36, depending on the pharmacy[3].

Revenue and Market Performance

Despite the initial hurdles, Cartia XT has contributed to the revenue growth of its manufacturers. Andrx reported that the launches of generic versions of high-sales-volume brand products, including Cartia XT, helped in returning the top-line trend in their distribution business to growth[2].

Legal and Regulatory Environment

The legal battles surrounding Cartia XT highlight the importance of antitrust laws in ensuring market competition. The agreement between Andrx and Hoechst was deemed a classic antitrust conspiracy, and courts have ruled that such agreements are per se illegal. This case set a precedent for future enforcement actions against similar practices in the pharmaceutical industry[5].

Consumer Impact

The availability of Cartia XT has been a boon for consumers, especially the elderly and those on fixed incomes. Generic versions of medications like Cartia XT can reduce healthcare expenses significantly, allowing consumers to afford their medications without compromising on other essential needs[5].

Side Effects and Safety Profile

While Cartia XT offers numerous benefits, it also comes with potential side effects. Common side effects include constipation, dizziness, flushing, headache, lightheadedness, nausea, and weakness. Serious side effects, such as dark urine, fainting, irregular heartbeat, and new or worsening symptoms of heart failure, require immediate medical attention[1].

Contraindications and Precautions

Cartia XT is contraindicated in patients with certain conditions, including sick sinus syndrome, second- or third-degree AV block without a functioning ventricular pacemaker, hypotension, and hypersensitivity to the drug. It is also contraindicated in patients with acute myocardial infarction and pulmonary congestion[4].

Drug Interactions

Cartia XT can interact with other medications, such as simvastatin, leading to increased exposures. For instance, coadministration of simvastatin with diltiazem can result in a significant increase in simvastatin AUC, necessitating dose adjustments to avoid adverse effects[4].

Market Trends and Future Outlook

The pharmaceutical market is highly competitive, and the trend towards generic medications continues to grow. As patents expire on brand-name drugs, generic versions like Cartia XT are expected to capture a larger market share, offering cost-effective alternatives to consumers. Regulatory bodies will continue to monitor the industry to prevent anticompetitive practices and ensure that consumers have access to affordable, effective medications[5].

Key Takeaways

  • Market Entry: Cartia XT's entry was delayed due to an illegal agreement between Andrx and Hoechst.
  • Pricing: Cartia XT offers significant cost savings compared to its brand-name counterpart.
  • Revenue: The drug has contributed to revenue growth for its manufacturers.
  • Legal Environment: The case against Andrx and Hoechst set a precedent for antitrust enforcement in the pharmaceutical industry.
  • Consumer Impact: Cartia XT has reduced healthcare expenses for consumers, especially the elderly.
  • Safety Profile: The drug has common and serious side effects that require medical attention.

FAQs

What is Cartia XT used for?

Cartia XT is used to treat hypertension, manage chronic stable angina, and alleviate angina due to coronary artery spasm.

Why was the market entry of Cartia XT delayed?

The market entry of Cartia XT was delayed due to an illegal agreement between Andrx and Hoechst, where Andrx was paid to keep the generic version off the market.

How does Cartia XT compare in price to its brand-name counterpart?

Cartia XT is significantly cheaper than its brand-name counterpart, Cardizem CD, offering substantial cost savings to consumers.

What are the common side effects of Cartia XT?

Common side effects include constipation, dizziness, flushing, headache, lightheadedness, nausea, and weakness.

Can Cartia XT interact with other medications?

Yes, Cartia XT can interact with medications like simvastatin, leading to increased exposures and necessitating dose adjustments.

Sources

  1. Canadian Pharmacy King: Cartia XT (Diltiazem CD) - https://www.canadianpharmacyking.com/Drug/Cartia+XT
  2. Gale: Andrx reports distributed products revenue increased 11.5% - https://go.gale.com/ps/i.do?id=GALE%7CA240615824&sid=sitemap&v=2.1&it=r&p=HRCA&sw=w&userGroupName=anon~33a66725&aty=open-web-entry
  3. Drugs.com: Cartia XT Prices, Coupons, Copay Cards & Patient Assistance - https://www.drugs.com/price-guide/cartia-xt
  4. Drugs.com: Cartia XT: Package Insert / Prescribing Information - https://www.drugs.com/pro/cartia-xt.html
  5. Maine.gov: AG ROWE FILES SUIT AGAINST DRUG MANUFACTURERS FOR KEEPING GENERIC HEART DRUG OFF MARKET - https://www.maine.gov/ag/news/article.shtml?id=48205

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