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Last Updated: December 22, 2024

DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% Drug Patent Profile


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Which patents cover Diltiazem Hydrochloride In Dextrose 5%, and when can generic versions of Diltiazem Hydrochloride In Dextrose 5% launch?

Diltiazem Hydrochloride In Dextrose 5% is a drug marketed by Exela Pharma and is included in one NDA.

The generic ingredient in DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% 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 Diltiazem Hydrochloride In Dextrose 5%

A generic version of DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% was approved as diltiazem hydrochloride by TEVA on May 31st, 1995.

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Summary for DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
Drug patent expirations by year for DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
Recent Clinical Trials for DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ascension Genesys HospitalPhase 2
Aurora Health CarePhase 4
Signia TherapeuticsPhase 2

See all DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% clinical trials

Pharmacology for DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%

US Patents and Regulatory Information for DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Exela Pharma DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% diltiazem hydrochloride SOLUTION;INTRAVENOUS 215252-001 Oct 28, 2021 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Exela Pharma DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% diltiazem hydrochloride SOLUTION;INTRAVENOUS 215252-002 Oct 28, 2021 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

DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% Market Analysis and Financial Projection Experimental

Diltiazem Hydrochloride Market Dynamics and Financial Trajectory

Overview of Diltiazem Hydrochloride

Diltiazem hydrochloride is a calcium channel blocker widely used in the treatment of hypertension, angina, and certain heart rhythm disorders. Its market has been experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The global diltiazem hydrochloride market has witnessed substantial growth and is anticipated to continue this trend. By 2023, the market had reached a value of several billion USD and is projected to attain even higher values by 2031, exhibiting a strong growth rate over the forecast period[1].

In North America, the diltiazem market is expected to grow from $161.53 million in 2021 to $369.22 million by 2028, with a Compound Annual Growth Rate (CAGR) of 12.5%[3].

Key Drivers of Market Growth

Increasing Prevalence of Cardiovascular Diseases

The rise in cardiovascular diseases, such as hypertension and angina, is a major driver of the diltiazem hydrochloride market. As the global population ages, the incidence of these conditions increases, leading to higher demand for effective treatments[3].

Government Initiatives and Healthcare Policies

Government initiatives aimed at promoting healthcare and managing chronic diseases have also contributed to the market's growth. These initiatives often include programs for early diagnosis and treatment, which can increase the demand for medications like diltiazem hydrochloride[3].

Impact of COVID-19

The COVID-19 pandemic has had a positive impact on the diltiazem market. The increased stress on healthcare systems and the need for managing hypertension and other cardiovascular conditions associated with COVID-19 have boosted the demand for diltiazem hydrochloride[4].

Market Segmentation

By Product Type

The diltiazem hydrochloride market is segmented into capsules, injections, and tablets. In 2021, the tablets segment held the largest share of the market, but the capsules segment is expected to witness the fastest CAGR from 2021 to 2028[3][4].

By Application

The market is also segmented by application into angina, hypertension, and other conditions. The hypertension segment held the largest share in 2021, while the angina segment is expected to grow at the fastest CAGR during the coming years[3][4].

Financial Performance and Projections

Revenue Growth

The global diltiazem hydrochloride market is projected to reach $832.51 million by 2028 from $369.95 million in 2021, growing at a CAGR of 12.3%[4].

Regional Performance

In North America, the market is expected to reach $369.22 million by 2028, up from $161.53 million in 2021. Similar growth trends are observed in other regions, including Europe and Asia Pacific, driven by the increasing prevalence of cardiovascular diseases and the impact of COVID-19[3][4].

Challenges and Restraints

Side Effects and Adverse Reactions

Despite the positive growth trajectory, the market faces challenges related to the side effects and adverse reactions associated with diltiazem hydrochloride. These include potential liver damage, dermatological events, and other rare but significant reactions[2][5].

Regulatory and Safety Concerns

The use of diltiazem hydrochloride in patients with impaired renal or hepatic function requires caution, and regular monitoring of liver and kidney function is necessary. This can limit its use in certain patient populations and impact market growth[2][5].

Competitive Landscape

The diltiazem hydrochloride market is competitive, with several pharmaceutical companies involved in its production and distribution. The market dynamics are influenced by the strategies of these companies, including product innovation, pricing, and marketing efforts.

Impact of COVID-19 on Supply Chain

The COVID-19 pandemic caused initial disruptions in the supply chain due to lockdowns and other restrictions. However, pharmaceutical companies adapted quickly, and the market saw growth as the demand for diltiazem hydrochloride increased due to its role in managing hypertension and other cardiovascular conditions associated with COVID-19[4].

Future Outlook

The future outlook for the diltiazem hydrochloride market remains positive, driven by the increasing demand for effective treatments for cardiovascular diseases. As the global population continues to age and the prevalence of these conditions rises, the market is expected to sustain its growth trajectory.

Emerging Trends

  • Increased Focus on Capsules: The capsules segment is expected to grow at the fastest CAGR, driven by patient preference and improved bioavailability[3][4].
  • Advancements in Formulations: Continuous research and development in formulations are expected to enhance the efficacy and safety profile of diltiazem hydrochloride, further boosting market growth.

Key Takeaways

  • The global diltiazem hydrochloride market is projected to grow significantly, driven by the increasing prevalence of cardiovascular diseases and the impact of COVID-19.
  • The market is segmented by product type and application, with tablets and hypertension treatment being the dominant segments.
  • Despite positive growth, the market faces challenges related to side effects and regulatory concerns.
  • The competitive landscape is dynamic, with pharmaceutical companies focusing on product innovation and strategic marketing.

FAQs

Q: What are the primary applications of diltiazem hydrochloride?

A: Diltiazem hydrochloride is primarily used in the treatment of hypertension, angina, and certain heart rhythm disorders.

Q: How has the COVID-19 pandemic affected the diltiazem hydrochloride market?

A: The COVID-19 pandemic has had a positive impact on the market, increasing demand due to the need for managing hypertension and other cardiovascular conditions associated with COVID-19.

Q: What are the potential side effects of diltiazem hydrochloride?

A: Potential side effects include liver damage, dermatological events, and other rare but significant reactions. Regular monitoring of liver and kidney function is necessary, especially in patients with impaired renal or hepatic function.

Q: Which segment is expected to grow the fastest in the diltiazem hydrochloride market?

A: The capsules segment is expected to witness the fastest CAGR from 2021 to 2028, driven by patient preference and improved bioavailability.

Q: What is the projected market size of the global diltiazem hydrochloride market by 2028?

A: The global diltiazem hydrochloride market is projected to reach $832.51 million by 2028, growing at a CAGR of 12.3% from 2021 to 2028[4].

Sources

  1. Market Research Intellect: Diltiazem Hydrochloride Market Size, Scope And Forecast Report.
  2. FDA: Cardizem LA (diltiazem hydrochloride) tablet label.
  3. Business Market Insights: Diltiazem Market in North America report 2028.
  4. Research and Markets: Global Diltiazem Market Forecast to 2028 - COVID-19 Impact and Recovery.
  5. FDA: Cardizem (diltiazem hydrochloride) tablets.

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