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-four 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:	1
Clinical Trials:	2
Patent Applications:	3,360
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

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

International Patents for TIAZAC

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0591424	DILTIAZEM SE PRESENTANT SOUS UNE FORME A LIBERATION PROLONGEE (EXTENDED-RELEASE FORM OF DILTIAZEM)
Denmark	0591424
World Intellectual Property Organization (WIPO)	9300093

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TIAZAC

Last updated: July 30, 2025

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Introduction

TiAZAC, a pharmaceutical compound commonly associated with treatment in areas such as cardiovascular health and water retention, is navigating a complex landscape marked by evolving market demands, regulatory developments, and technological innovations. Understanding its market dynamics and financial trajectory is critical for stakeholders aiming to optimize investment strategies, optimize manufacturing, or develop competitive positioning.

Overview of TiAZAC and Therapeutic Indications

TiAZAC (generic name: Hydrochlorothiazide) belongs to the thiazide diuretic class, widely prescribed for managing hypertension, edema, and related cardiovascular conditions. Its longstanding presence in clinical practice, coupled with broad indications, has historically cemented its role in therapeutics, especially in developing economies. Areas where TiAZAC resembles brand drugs like Microzide continue to see steady prescribing patterns, driven by established safety profiles and affordability.

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Market Drivers Shaping TiAZAC’s Trajectory

1. Growing Global Disease Burden and Demographic Shifts

The rising prevalence of hypertension and heart failure has driven demand for diuretics. According to the World Health Organization, cardiovascular diseases account for approximately 17.9 million deaths annually, amplifying the need for affordable, reliable medications like TiAZAC. Aging populations, particularly in North America and Europe, further bolster this trend, as older cohorts require chronic therapy.

2. Cost-Effectiveness and Market Penetration in Emerging Economies

In low- and middle-income countries, the affordability of generic TiAZAC solidifies its position as a first-line treatment. Governments and insurance schemes favor low-cost options, impacting sales volumes positively. A surge in local manufacturing, facilitated by patent expirations, enhances availability and reduces prices, expanding market reach.

3. Patent Expirations and Generic Competition

Patent expiry periods traditionally prompt significant market shifts. Hydrochlorothiazide patents expired in the early 2000s, resulting in widespread generics. This commoditization has compressed profit margins but increased volume sales, stabilizing revenue streams across various regions. The proliferation of generic manufacturers intensifies competition, necessitating strategic differentiation.

4. Regulatory Environment and Patent Litigation

Regulatory pathways for approval are streamlined in many jurisdictions, but recent policies emphasizing quality control impose standards that can influence manufacturing costs and timelines. Patent litigations or patent cliff events in certain markets can create windows for generic entrants or prompt brand consolidation.

5. Competitive Landscape and Pharmaceutical Innovation

While TiAZAC remains a cornerstone therapy, emerging compounds and combination drugs threaten to encroach upon its market share. Novel antihypertensive agents with improved efficacy or reduced side effects, such as ARNI (Angiotensin Receptor-Neprilysin Inhibitors), pose substitution risks, especially in developed economies.

6. Technological Advances and Digital Therapeutics

Digital health solutions augment traditional therapies, influencing prescribing behaviors. Telemedicine and remote monitoring facilitate optimized management, potentially shifting demand dynamics for diuretics like TiAZAC based on patient monitoring efficacy.

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Market Trends and Forecasts

Global Market Size and Growth Projections

The global diuretics market, including TiAZAC, was valued at approximately USD 2.5 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 4.8% through 2030. Factors fueling this include high prevalence of hypertension, increased healthcare access, and expanded indications.

Regional Market Dynamics

• North America: Mature market with high penetration, driven by ongoing cardiovascular disease management and strict regulatory oversight. Growth perspectives focus on optimizing therapy adherence and expanding combination formulations.

• Europe: Similar maturity to North America but with strong focus on generic substitution policies. Price sensitivity influences market shares.

• Asia-Pacific: Fastest-growing segment due to rising hypertension prevalence, urbanization, and economic growth. Local manufacturing and regulatory simplification further accelerate market expansion.

• Latin America and Africa: Emerging markets with substantial growth potential contingent on healthcare infrastructure development and affordability.

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Financial Trajectory and Investment Implications

Revenue Streams

TiAZAC’s financial health is predominantly driven by high-volume sales in generic form, with revenue stability benefiting from minimal R&D expenditures due to its status as a well-established compound. However, profit margins are pressured by intense price competition and commoditization.

Cost Structure and Profitability

Manufacturing costs remain relatively low, but compliance with evolving regulatory standards raises compliance costs. Strategic cost control and economies of scale are vital for maintaining profitability.

Impact of Patent and Regulatory Events

Patent expirations have historically caused revenue dips but opened opportunities for generics manufacturers. Future patent filings or exclusivity periods influence the financial pipeline, with potential for branded formulations commanding premium pricing if innovation occurs (e.g., extended-release formulations or combination therapies).

Potential for Value-Added Formulations

Innovative formulations—such as sustained-release versions or fixed-dose combinations—offer avenues for higher margins and market differentiation. Investment in such development can sustain revenue streams amid intense generic competition.

Market Entry and Expansion Strategies

Stakeholders should explore strategic alliances, vertical integration, or regional manufacturing hubs to capitalize on emerging markets' growth potential. Diversification into adjacent therapeutic areas or innovative drug delivery platforms can mitigate risks associated with market saturation.

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Regulatory and Competitive Challenges

Regulatory uncertainty, patent disputes, and the emergence of new standards (e.g., quality control, bioequivalence) influence revenue stability. Investors need to monitor patent timelines, litigation risks, and evolving approval requirements.

Market competition from newer antihypertensives or combination therapies necessitates continuous innovation and marketing strategies to sustain market share.

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Conclusion

TiAZAC’s market dynamics are characterized by its foundational role in hypertension and edema management, driven by affordability and established efficacy. Its financial trajectory remains resilient but faces headwinds from patent expirations, competitive innovations, and regulatory shifts. A strategic focus on manufacturing efficiencies, formulation innovation, and expansion into emerging markets can optimize long-term profitability.

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Key Takeaways

• Market Growth driven by aging populations, rising hypertension rates, and cost-sensitive markets sustain demand for TiAZAC.
• Generic Competition exerts pressure on profit margins but ensures broad access and high sales volumes.
• Innovation Opportunities such as combination formulations or novel delivery systems offer avenues to differentiate and command premium pricing.
• Regulatory and Patent Timelines are pivotal; monitoring these events guides strategic decision-making.
• Market Expansion into Asia-Pacific and Latin America remains essential for sustained growth, leveraging regional manufacturing and partnerships.

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FAQs

1. How will patent expirations impact TiAZAC’s market share?
Patent expirations lead to increased generic competition, typically resulting in price reductions and market share redistribution. However, effective branding and formulation innovations can mitigate declines.

2. What emerging therapies threaten TiAZAC’s market dominance?
Newer antihypertensive agents like ARNI and combination drugs offer better efficacy or fewer side effects, potentially replacing TiAZAC in some indications, especially in developed markets.

3. Are there regulatory barriers affecting TiAZAC’s global expansion?
Regulatory standards vary; stringent bioequivalence and quality controls can influence manufacturing costs and approval timelines, especially in emerging markets.

4. What strategies are pharmaceutical companies employing to maintain profitability?
Investing in formulation innovation, expanding into new markets, forming strategic partnerships, and diversifying product portfolios help sustain revenue streams.

5. How significant is the role of digital health in TiAZAC’s future market?
Digital health tools improve therapy adherence and patient monitoring, potentially increasing demand for affordable medications like TiAZAC by enhancing overall disease management.

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References

[1] World Health Organization. Cardiovascular diseases (CVDs). 2021.
[2] Market Research Future. Diuretics Market Analysis & Forecast (2023–2030).
[3] IMS Health. Global Cardiovascular Drugs Market Report. 2022.
[4] U.S. FDA. Guidance for Industry: Bioequivalence Requirements. 2021.
[5] Frost & Sullivan. Asia-Pacific Hypertension Market Trends. 2022.