DILACOR XR Drug Patent Profile

When do Dilacor Xr patents expire, and when can generic versions of Dilacor Xr launch?

Dilacor Xr is a drug marketed by Allergan and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dilacor Xr

A generic version of DILACOR XR was approved as diltiazem hydrochloride by TEVA on May 31^st, 1995.

Summary for DILACOR XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	1
Patent Applications:	76
DailyMed Link:	DILACOR XR at DailyMed

Recent Clinical Trials for DILACOR XR

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

Sponsor	Phase
Assiut University	Early Phase 1

See all DILACOR XR clinical trials

US Patents and Regulatory Information for DILACOR XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-001	May 29, 1992		DISCN	Yes	No
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-002	May 29, 1992		DISCN	Yes	No
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-003	May 29, 1992		DISCN	Yes	No

Expired US Patents for DILACOR XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-001	May 29, 1992	4,839,177
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-003	May 29, 1992	4,839,177
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-003	May 29, 1992	5,422,123
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-001	May 29, 1992	5,422,123
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-002	May 29, 1992	5,422,123
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-002	May 29, 1992	4,839,177

International Patents for DILACOR XR

See the table below for patents covering DILACOR XR around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1298479	SYSTEME POUR LA LIBERATION PROGRESSIVE DE SUBSTANCES ACTIVES (SYSTEM FOR THE CONTROLLED-RATE RELEASE OF ACTIVE SUBSTANCES)
Germany	3675748
Italy	1188212	SISTEMA PER IL RILASCIO A VELOCITA' CONTROLLATA DI SOSTANZE ATTIVE
Italy	8523321
Japan	2907557
New Zealand	218596	SYSTEM FOR THE CONTROLLED RELEASE OF ACTIVE SUBSTANCES

Market Dynamics and Financial Trajectory for Dilacor XR

Introduction

Dilacor XR, a formulation of diltiazem hydrochloride, is an extended-release calcium channel blocker used primarily for the treatment of hypertension and chronic stable angina. To understand the market dynamics and financial trajectory of Dilacor XR, it is essential to examine its historical performance, market factors, and the broader pharmaceutical industry context.

Historical Performance

Sales and Revenue

In the late 1990s, Dilacor XR was a significant contributor to Watson Pharmaceuticals' revenue. Following the acquisition of the rights to Dilacor XR in June 1997, the product accounted for approximately 19% of Watson's total revenues in 1997. However, due to increased generic competition and supply interruptions, sales of Dilacor XR decreased to about 15% of net revenues in 1998 and further to 7% in 1999[1].

Impact of Generic Competition

The decline in sales was largely attributed to the increased presence of generic alternatives. Generic competition is a major factor in the pharmaceutical industry, often leading to significant price reductions and market share erosion for branded products. Despite efforts to secure an alternate supply source in March 2000, the commercial viability of Dilacor XR as a generic product was compromised due to the competitive pricing structure[1].

Market Factors

Competitive Landscape

The market for calcium channel blockers is highly competitive, with multiple branded and generic options available. Dilacor XR competes with other extended-release formulations like Cardizem CD, as evidenced by pharmacokinetic studies comparing these products[3].

Regulatory Environment

Regulatory approvals and compliance play a crucial role in the pharmaceutical industry. Delays in receiving FDA approvals for new products can significantly impact a company's financial performance. For instance, Watson Pharmaceuticals experienced delays in obtaining FDA approvals for new generic products in 1999, which affected their revenue from off-patent products[1].

Patient and Physician Acceptance

The acceptance of off-patent drugs by physicians, pharmacists, and consumers is another critical factor. While there was an increasing acceptance of off-patent drugs in the late 1990s, the phasing out of certain products and increased price competition further impacted Dilacor XR's market share[1].

Financial Trajectory

Revenue Trends

The financial performance of Dilacor XR is closely tied to the overall revenue trends of its parent company. In 1999, branded product sales, including Dilacor XR, accounted for 50% of Watson Pharmaceuticals' total revenues, while off-patent product sales accounted for 45%. However, the revenue contribution from Dilacor XR specifically declined due to the aforementioned factors[1].

Impact on Company Growth

Despite the decline in Dilacor XR sales, Watson Pharmaceuticals continued to grow through strategic acquisitions and the expansion of their branded product portfolio. The company's growth strategy included acquiring businesses and products complementary to their existing operations, which helped mitigate the impact of declining sales from individual products like Dilacor XR[1].

Pharmacological and Clinical Aspects

Efficacy and Safety

Dilacor XR has been shown to be effective in treating hypertension and chronic stable angina through its mechanism of action as a calcium channel blocker. Clinical studies have demonstrated a dose-related antihypertensive response, with significant reductions in both systolic and diastolic blood pressure[4].

Side Effects and Contraindications

While Dilacor XR is generally well-tolerated, it can cause various side effects, including peripheral edema, headache, and dizziness. Contraindications include conditions such as sick sinus syndrome, second or third-degree AV block, and acute myocardial infarction with pulmonary congestion[4][5].

Market Dynamics Today

Current Market Position

As of the current date, Dilacor XR remains a prescribed medication for hypertension and angina, although its market share has likely continued to be impacted by generic competition and other branded alternatives.

Future Outlook

The future outlook for Dilacor XR is influenced by the broader trends in the pharmaceutical industry, including the increasing importance of generic and biosimilar drugs, advancements in cardiovascular treatment options, and evolving regulatory landscapes.

Key Takeaways

• Historical Sales Decline: Dilacor XR's sales declined significantly in the late 1990s due to generic competition and supply interruptions.
• Competitive Landscape: The market for calcium channel blockers is highly competitive, with multiple branded and generic options.
• Regulatory Impact: Delays in FDA approvals can significantly affect a product's financial performance.
• Clinical Efficacy: Dilacor XR is effective in treating hypertension and angina but comes with potential side effects and contraindications.
• Future Outlook: The product's future is shaped by industry trends, including the rise of generics and biosimilars.

FAQs

What is Dilacor XR used for?

Dilacor XR is used for the treatment of hypertension and chronic stable angina.

Why did Dilacor XR's sales decline in the late 1990s?

The sales decline was primarily due to increased generic competition and supply interruptions from third-party suppliers.

How does Dilacor XR work?

Dilacor XR works by affecting the movement of calcium into the cells of the heart and blood vessels, relaxing the blood vessels, and lowering blood pressure.

What are the common side effects of Dilacor XR?

Common side effects include peripheral edema, headache, dizziness, and respiratory issues like cough and pharyngitis.

Is Dilacor XR still prescribed today?

Yes, Dilacor XR remains a prescribed medication for hypertension and angina, although its market share has been impacted by generic competition.

Sources

1. Watson Pharmaceuticals, Inc. - 10K Report 1999.
2. Drugs.com - Dilacor XR Advanced Patient Information.
3. PubMed - Comparative Pharmacokinetics and Bioavailability of Dilacor XR.
4. FDA - Dilacor XR Label.
5. Drugs.com - Dilacor XR Side Effects.