CARDENE SR Drug Patent Profile

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

Cardene Sr is a drug marketed by Chiesi and is included in one NDA.

The generic ingredient in CARDENE SR is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cardene Sr

A generic version of CARDENE SR was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE SR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	173
Clinical Trials:	9
Patent Applications:	1,618
DailyMed Link:	CARDENE SR at DailyMed

Recent Clinical Trials for CARDENE SR

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

Sponsor	Phase
Boston Medical Center	Phase 4
Vanderbilt University Medical Center	Phase 2
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2

See all CARDENE SR clinical trials

US Patents and Regulatory Information for CARDENE SR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-001	Feb 21, 1992		DISCN	Yes	No
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992		DISCN	Yes	No
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992		DISCN	Yes	No

Expired US Patents for CARDENE SR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992	3,985,758
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992	5,198,226
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-001	Feb 21, 1992	3,985,758
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992	5,198,226
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992	3,985,758
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-001	Feb 21, 1992	5,198,226

International Patents for CARDENE SR

See the table below for patents covering CARDENE SR around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1029021
Hungary	196709	PROCESS FOR PRODUCING LONG ACTING PHARMACEUTICAL COMPOSITION
Italy	1206876	COMPOSIZIONI FARMACEUTICHE A CESSIONE PROLUNGATA RELATIVE FORME DI DOSAGGIO E PROCEDIMENTO PER LA LORO PREPARAZIONE
Japan	S5084576
Japan	S5714348
Netherlands	176559
Switzerland	605755

Market Dynamics and Financial Trajectory for CARDENE SR

Introduction

CARDENE SR, a sustained-release formulation of nicardipine hydrochloride, is a calcium ion influx inhibitor used primarily for the treatment of hypertension. Understanding the market dynamics and financial trajectory of this drug is crucial for investors, pharmaceutical companies, and healthcare professionals.

Market Position and Indications

CARDENE SR is indicated for the treatment of hypertension and can be used alone or in combination with other anti-hypertensive drugs. Its efficacy in reducing both systolic and diastolic blood pressure throughout the dosing interval has been demonstrated in clinical trials, making it a viable option for managing mild to moderate hypertension[1][5].

Historical Acquisition and Financing

The drug has undergone significant changes in ownership and financing over the years. In 2005, PDL BioPharma Inc. acquired the cardiovascular products of ESP Pharma Inc., including CARDENE SR, for $500 million. Later, in 2008, EKR Therapeutics Inc. purchased these products from PDL BioPharma for $85 million in cash, plus up to $85 million in development and sales milestones, and royalties on sales[2].

Financial Performance

Under the management of EKR Therapeutics, the sales of CARDENE SR and its formulations saw significant growth. Before the acquisition by EKR, PDL BioPharma had pushed the sales of CARDENE to $155.5 million in 2007. EKR's experience with the drug and its ability to promote it effectively contributed to its financial success. The company's sales team was expanded to 80 people across 48 states, which helped in promoting not only CARDENE SR but also other products like DepoDur and Gelclair[2].

Competitive Landscape

The market for hypertension treatments is competitive, with several other drugs and formulations available. One of the key competitors to CARDENE SR is Cleviprex, an acute-hypertension therapy developed by The Medicines Co. However, EKR Therapeutics' strategy to switch physicians from the intravenous formulation (CARDENE I.V.) to new, improved oral formulations like CARDENE SR helped in maintaining market share despite the looming patent expiration of CARDENE I.V. in 2009[2].

Pharmacokinetics and Patient Response

The pharmacokinetics of CARDENE SR show a significant reduction in the fluctuation of plasma levels compared to the immediate-release formulation. This stability is beneficial for patients, as it reduces the peak-to-trough variability, making it easier to manage hypertension. The drug's performance in patients with moderate renal impairment and elderly patients has also been favorable, with no significant differences in pharmacokinetic parameters compared to younger patients[1][5].

Adverse Events and Safety Profile

Clinical trials have identified several adverse events associated with CARDENE SR, including headache, pedal edema, vasodilatation, and palpitation. However, these events are generally not serious, and only about 9% of patients withdrew from the studies due to adverse events. The safety profile of CARDENE SR is relatively good, although it is contraindicated in patients with hypersensitivity to the drug and advanced aortic stenosis[1][5].

Market Expansion and Future Prospects

The financing secured by EKR Therapeutics, including $95 million in senior debt and a $50 million Series D funding, has been instrumental in scaling the business. The company's strategy to promote a broader product line and expand its sales team has helped in increasing its market presence. With ongoing efforts to develop new therapies and improve existing formulations, CARDENE SR is likely to remain a significant player in the hypertension treatment market[2].

Key Takeaways

• Market Position: CARDENE SR is a sustained-release formulation of nicardipine hydrochloride, indicated for hypertension treatment.
• Financial Performance: The drug has seen significant sales growth under EKR Therapeutics, with sales reaching $155.5 million in 2007.
• Competitive Landscape: The market is competitive, but EKR's strategies have helped maintain market share.
• Pharmacokinetics: The drug shows stable plasma levels, beneficial for managing hypertension.
• Safety Profile: Generally well-tolerated, with common adverse events being headache and pedal edema.
• Future Prospects: Continued development and promotion are expected to sustain its market presence.

FAQs

Q: What is CARDENE SR used for? A: CARDENE SR is used for the treatment of hypertension and can be used alone or in combination with other anti-hypertensive drugs.

Q: Who are the key players involved in the ownership and financing of CARDENE SR? A: The key players include PDL BioPharma Inc., EKR Therapeutics Inc., and various investors such as MPM Capital and LLR Partners.

Q: How has the financial performance of CARDENE SR been? A: The drug has seen significant sales growth, reaching $155.5 million in 2007 under PDL BioPharma, and continued to be financially successful under EKR Therapeutics.

Q: What are the common adverse events associated with CARDENE SR? A: Common adverse events include headache, pedal edema, vasodilatation, and palpitation.

Q: Is CARDENE SR contraindicated in any specific patient groups? A: Yes, it is contraindicated in patients with hypersensitivity to the drug and those with advanced aortic stenosis.

Sources

1. CARDENE® SR - (nicardipine hydrochloride) - accessdata.fda.gov
2. EKR Swallows $145M For Hospital Drugs - LLR Partners
3. Seventh Report of the Joint National Committee on Prevention ... - ahajournals.org
4. HIGHLIGHTS OF PRESCRIBING INFORMATION These ... - Baxter PI
5. CARDENE SR- nicardipine hydrochloride capsule ... - DailyMed