TIAZAC Drug Patent Profile

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

Tiazac is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in TIAZAC 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 Tiazac

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

Summary for TIAZAC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	188
Clinical Trials:	2
Patent Applications:	2,870
Drug Prices:	Drug price information for TIAZAC
What excipients (inactive ingredients) are in TIAZAC?	TIAZAC excipients list
DailyMed Link:	TIAZAC at DailyMed

See drug prices for TIAZAC

Recent Clinical Trials for TIAZAC

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

Sponsor	Phase
Assiut University	Early Phase 1
Bayer	Phase 3

See all TIAZAC clinical trials

Pharmacology for TIAZAC

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

US Patents and Regulatory Information for TIAZAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-001	Sep 11, 1995	AB4	RX	Yes	No
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-004	Sep 11, 1995	AB4	RX	Yes	No
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-002	Sep 11, 1995	AB4	RX	Yes	No
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-003	Sep 11, 1995	AB4	RX	Yes	No
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-006	Oct 16, 1998	AB4	RX	Yes	Yes
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-005	Sep 11, 1995	AB4	RX	Yes	No

Expired US Patents for TIAZAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-005	Sep 11, 1995
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-003	Sep 11, 1995
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-005	Sep 11, 1995
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-001	Sep 11, 1995
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-004	Sep 11, 1995
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-006	Oct 16, 1998
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-003	Sep 11, 1995

International Patents for TIAZAC

See the table below for patents covering TIAZAC around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69229949
Austria	184196
Denmark	0591424
Japan	2000026278	EXTENDED RELEASING PREPARATION OF DILTIAZEM HYDROCHLORIDE
Canada	2111085	FORMULATION DE DILTIAZEM A LIBERATION LENTE (EXTENDED-RELEASE FORM OF DILTIAZEM)
European Patent Office	0953350
European Patent Office	0591424	DILTIAZEM SE PRESENTANT SOUS UNE FORME A LIBERATION PROLONGEE (EXTENDED-RELEASE FORM OF DILTIAZEM)

TIAZAC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tiazac

Introduction

Tiazac, a brand name for the calcium channel blocker diltiazem, is a crucial medication in the treatment of hypertension, angina, and certain heart rhythm disorders. Understanding the market dynamics and financial trajectory of Tiazac is essential for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The global calcium channel blocker drugs market, which includes Tiazac, is substantial and growing. As of 2022, the market was valued at US$ 14,285.3 million and is expected to exhibit a Compound Annual Growth Rate (CAGR) of 5.2% from 2022 to 2030, reaching a projected value of US$ 21,489.7 million by 2030[1].

Key Indications and Usage

Tiazac is primarily used for the treatment of:

• Hypertension: Clinical trials have shown that Tiazac demonstrates a dose-related antihypertensive response, significantly reducing diastolic and systolic blood pressure in patients with mild to moderate hypertension[4].
• Angina: Tiazac increases exercise tolerance time and reduces anginal attacks and nitroglycerin requirements in patients with chronic stable angina[4].

Pharmacokinetics and Efficacy

Tiazac capsules exhibit high bioavailability, with approximately 93% of the drug absorbed from the formulation. The drug shows non-linear pharmacokinetics, with a more than proportional increase in diltiazem plasma concentrations as the dose increases[4].

Market Drivers

Increasing Prevalence of Hypertension

The rising prevalence of hypertension globally is a significant driver for the calcium channel blocker market, including Tiazac. Hypertension is a major risk factor for cardiovascular diseases, and the demand for effective antihypertensive medications is increasing[1].

Clinical Efficacy

The proven clinical efficacy of Tiazac in managing hypertension and angina contributes to its market demand. The drug's ability to reduce blood pressure and improve exercise tolerance in angina patients makes it a preferred choice among healthcare providers[4].

Competitive Landscape

Tiazac operates in a competitive market with several other calcium channel blockers. Key competitors include:

• Amlodipine (Norvasc)
• Felodipine
• Isradipine
• Nicardipine
• Other brands from companies like Bausch Health, Mylan N.V., Teva Pharmaceutical Industries Ltd, and Pfizer Inc.[1].

Financial Performance of Bausch Health

Bausch Health, the company behind Tiazac, has reported mixed financial results in recent years. In the second quarter of 2021, Bausch Health generated revenues of $2,100 million, with a gross margin of 70.9%. However, the company also reported a GAAP net loss of $595 million, partly due to legacy legal settlements and other expenses[5].

Revenue Contribution

Tiazac, along with other products, contributes to Bausch Health's revenue stream. While specific revenue figures for Tiazac are not always disclosed separately, the overall performance of Bausch Health's cardiovascular segment is influenced by the sales of Tiazac and other related medications.

Cash Flow and Debt

Bausch Health has generated significant cash from operations, with $395 million in GAAP cash flow from operations during the second quarter of 2021. However, the company also carries substantial debt, with total debt balances exceeding $23 billion as of 2021[5].

Challenges and Restraints

Regulatory and Legal Issues

Pharmaceutical companies, including those producing calcium channel blockers like Tiazac, face regulatory and legal challenges. Drug withdrawals, as seen in the case of Vioxx, can have significant financial and market impacts, affecting not only the withdrawn drug but also other products in the company's portfolio[3].

Generic Competition

The expiration of patents for branded drugs can lead to generic competition, which can erode market share and revenue. As patents for Tiazac and other calcium channel blockers expire, generic versions may enter the market, potentially impacting sales.

Impact of Drug Withdrawals

The withdrawal of a drug from the market can have far-reaching consequences, including:

• Immediate Financial Impact: Loss of revenue from the withdrawn drug.
• Spillover Effects: Negative impacts on the sales of other brands within the company’s portfolio and on the company’s stock price[3].

Future Outlook

The future outlook for Tiazac and the broader calcium channel blocker market is positive, driven by the increasing prevalence of hypertension and the drug's proven efficacy. However, the market will need to navigate challenges such as generic competition and regulatory scrutiny.

Key Takeaways

• Growing Market: The global calcium channel blocker market is expected to grow at a CAGR of 5.2% from 2022 to 2030.
• Clinical Efficacy: Tiazac is effective in treating hypertension and angina.
• Competitive Landscape: Tiazac competes with other calcium channel blockers from various pharmaceutical companies.
• Financial Performance: Bausch Health’s financial performance is influenced by the sales of Tiazac and other products.
• Challenges: Regulatory issues, generic competition, and potential drug withdrawals are key challenges.

FAQs

What is Tiazac used for?

Tiazac is used for the treatment of hypertension, angina, and certain heart rhythm disorders.

Who manufactures Tiazac?

Tiazac is manufactured by Bausch Health.

What is the expected growth rate of the calcium channel blocker market?

The global calcium channel blocker market is expected to exhibit a CAGR of 5.2% from 2022 to 2030.

How does Tiazac compare to other calcium channel blockers?

Tiazac is one of several calcium channel blockers available, each with its own pharmacokinetic profile and clinical efficacy. It is known for its high bioavailability and non-linear pharmacokinetics.

What are the potential challenges facing Tiazac in the market?

Tiazac faces challenges such as generic competition, regulatory and legal issues, and the potential for drug withdrawals which can impact its market share and revenue.

Sources

1. Coherent Market Insights: Calcium Channel Blocker Drugs Market Size by 2030.
2. Bausch Health: Financial Results - Bausch Health Companies Inc.
3. University of Georgia: A Study of Prescription Drug Withdrawals.
4. DailyMed: TIAZAC EXTENDED RELEASE- diltiazem hydrochloride capsule.
5. Bausch Health: Financial Results - Bausch Health Companies Inc. (2Q21).