CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER Drug Patent Profile

When do Cardene In 0.86% Sodium Chloride In Plastic Container patents expire, and what generic alternatives are available?

Cardene In 0.86% Sodium Chloride In Plastic Container is a drug marketed by Chiesi and is included in one NDA. There are six patents protecting this drug.

This drug has twenty-one patent family members in ten countries.

The generic ingredient in CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cardene In 0.86% Sodium Chloride In Plastic Container

A generic version of CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

International Patents:	21
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	9
DailyMed Link:	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

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

Sponsor	Phase
Boston Medical Center	Phase 4
University of Cincinnati	Phase 2
Vanderbilt University Medical Center	Phase 2

See all CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER clinical trials

Pharmacology for CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors

US Patents and Regulatory Information for CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008	AP	RX	Yes	Yes	7,659,291
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008	AP	RX	Yes	Yes	9,364,564		Y
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008	AP	RX	Yes	Yes	8,455,524
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008	AP	RX	Yes	Yes	11,547,758
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008	AP	RX	Yes	Yes	10,758,616		Y

International Patents for CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

See the table below for patents covering CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	142869
Australia	2007237903	Pre-mixed, ready-to-use iv bolus compositions and methods of use
Canada	2650922
United Kingdom	9004385
China	101484136	Pre-mixed, ready-to-use pharmaceutical compositions

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CARDENE I.V. (Nicardipine Hydrochloride) in 0.86% Sodium Chloride

Overview of CARDENE I.V.

CARDENE I.V. (nicardipine hydrochloride) is a calcium channel blocker used for the short-term treatment of hypertension when oral therapy is not feasible or desirable. It is manufactured in ready-to-administer bags and has a documented efficacy in treating acute severe hypertension and acute postoperative hypertension[3].

Market Context: Pharmaceutical Industry Trends

The pharmaceutical industry is currently navigating several key trends that impact the market dynamics and financial trajectory of drugs like CARDENE I.V.

Revenue Growth and Challenges

The global branded pharmaceutical industry is expected to experience healthy revenue growth through 2027, despite challenges such as products losing exclusivity, growing biosimilar competition, and Medicare price negotiations under the Inflation Reduction Act (IRA)[2].

Impact of Patent Expirations and Biosimilars

The industry faces headwinds from expiring patents and increasing biosimilar competition. However, new drug approvals and pipeline assets are expected to drive growth. For example, therapeutic areas like oncology, rare diseases, and neurology are pivotal for near-term pipeline assets[1][2].

Pricing Dynamics and Regulatory Pressures

Drug pricing dynamics, particularly the IRA's cap on price increases across Medicare channels, create margin pressures for distributors and manufacturers. However, new drug launches are anticipated to offset these losses and drive mid-single-digit growth for major distributors[1][2].

Specific Market Dynamics for CARDENE I.V.

Competitive Landscape

Nicardipine hydrochloride, the active ingredient in CARDENE I.V., targets Cav2.1 and is used in treating various cardiovascular and nervous system diseases. The competitive landscape is intense, with companies like Bayer AG, LTL Pharma Co., Ltd., and CHIESI Farmaceutici SpA having multiple approved drugs in this space[4].

Geographical Focus

The development of drugs targeting Cav2.1, including nicardipine hydrochloride, is significant in countries like China, the European Union, Japan, and the United States. This global focus indicates a broad market potential for CARDENE I.V.[4].

Clinical Indications and Usage

CARDENE I.V. is specifically indicated for the short-term treatment of hypertension when oral therapy is not feasible. Its efficacy in different clinical settings, such as acute severe hypertension and acute postoperative hypertension, positions it as a valuable option in critical care scenarios[3].

Financial Trajectory

Revenue Growth Prospects

Given the robust wave of new drug approvals and the growing demand for cardiovascular treatments, CARDENE I.V. is likely to benefit from these trends. The pharmaceutical industry's overall revenue growth, driven by new therapies and pipeline assets, suggests a positive financial trajectory for drugs like CARDENE I.V.[2].

Pricing and Margin Considerations

While the IRA's price caps and increasing biosimilar competition may exert pressure on margins, the strong demand for effective hypertension treatments and the drug's unique positioning in critical care settings should help maintain its market value. Manufacturers and distributors are expected to adapt by focusing on R&D and other growth areas to offset potential losses[1][2].

Market Share and Competition

The intense competition in the cardiovascular drug market means that CARDENE I.V. must continually demonstrate its efficacy and value to healthcare providers. However, its established use and ready-to-administer format provide competitive advantages that can help maintain market share[3][4].

Industry Expert Insights

Adaptation to Market Pressures

"Pharma companies will adapt and continue to prioritize investment in R&D and M&A to support revenue growth, even if industry conditions become a little less favorable," notes an analysis by S&P Global Ratings. This adaptability is crucial for drugs like CARDENE I.V. to thrive in a changing market environment[2].

Focus on Innovation

"Leading tech companies can serve as models for pharmaceutical companies in areas like developing digital products and personalizing customer engagement," according to PwC. This emphasis on innovation can help CARDENE I.V. stay competitive by integrating digital solutions and personalized care approaches[5].

Key Statistics and Forecasts

• The global branded pharmaceutical industry is expected to see healthy revenue growth through 2027, with some companies like Eli Lilly & Co. and Novo Nordisk experiencing outsized revenue growth due to their leadership in obesity drugs[2].
• The big three drug distributors in the US (Cardinal Health, Cencora, and McKesson) are expected to achieve mid-single-digit compound annual growth rates over the next five years, driven by macro trends such as an aging population and growth in prescription expenditures[1].

Conclusion

CARDENE I.V. operates within a dynamic pharmaceutical market influenced by trends such as new drug approvals, patent expirations, and regulatory pressures. Despite these challenges, its unique clinical indications, ready-to-administer format, and the overall growth in the pharmaceutical industry position it for a stable financial trajectory.

Key Takeaways

• Market Trends: The pharmaceutical industry faces challenges from patent expirations and biosimilar competition but is expected to grow due to new drug approvals and pipeline assets.
• Competitive Landscape: CARDENE I.V. competes in a crowded market with several major players, but its specific indications and ready-to-administer format provide competitive advantages.
• Financial Prospects: The drug is likely to benefit from the overall revenue growth in the pharmaceutical industry, despite margin pressures from regulatory changes.
• Innovation: Focus on R&D and digital solutions is crucial for maintaining market share and adapting to changing market conditions.

FAQs

Q: What is CARDENE I.V. used for?

A: CARDENE I.V. (nicardipine hydrochloride) is used for the short-term treatment of hypertension when oral therapy is not feasible or desirable.

Q: How does the competitive landscape affect CARDENE I.V.?

A: The competitive landscape is intense, with several companies having approved drugs targeting the same therapeutic area. However, CARDENE I.V.'s specific indications and ready-to-administer format provide it with competitive advantages.

Q: What are the key market trends impacting CARDENE I.V.?

A: Key trends include new drug approvals, patent expirations, biosimilar competition, and regulatory pressures such as the Inflation Reduction Act.

Q: How is the pharmaceutical industry adapting to market pressures?

A: The industry is adapting by prioritizing investment in R&D and M&A, and by focusing on innovation and digital solutions to maintain revenue growth.

Q: What are the financial prospects for CARDENE I.V. in the next five years?

A: Despite margin pressures, CARDENE I.V. is likely to benefit from the overall revenue growth in the pharmaceutical industry, driven by new therapies and pipeline assets.

Sources

1. Morningstar: "3 Stocks to Watch in the Drug Distribution Industry"
2. S&P Global Ratings: "Pharmaceutical Industry 2024 Credit Outlook Is Stable As Revenue Growth Mitigates Pressures"
3. Baxter: "CARDENE I.V. (nicardipine hydrochloride) Injection"
4. Patsnap Synapse: "Unleashing the Power of nicardipine hydrochloride - A Comprehensive Review on R&D Breakthroughs"
5. PwC: "Next in pharma: How can pharmaceutical companies drive growth?"