DILTIAZEM HYDROCHLORIDE Drug Patent Profile

Which patents cover Diltiazem Hydrochloride, and what generic alternatives are available?

Diltiazem Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Alembic, Apotex, Biovail, Chartwell Rx, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Macleods Pharms Ltd, Mylan, Nesher Pharms, Novast Labs, Ph Health, Pharmobedient, Sun Pharm, Teva, Twi Pharms, Utopic Pharms, Valeant Pharms North, Zydus Pharms, Dr Reddys, Eugia Pharma, Hikma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, Amta, Sciegen Pharms, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, Teva Pharms, Zydus Lifesciences, Hq Spclt Pharma, and Exela Pharma. and is included in fifty-eight NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diltiazem Hydrochloride

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

Summary for DILTIAZEM HYDROCHLORIDE

US Patents:	0
Applicants:	40
NDAs:	58
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DILTIAZEM HYDROCHLORIDE

Paragraph IV (Patent) Challenges for DILTIAZEM HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CARDIZEM LA	Extended-release Tablets	diltiazem hydrochloride	120 mg, 180 mg, 240 mg, 300 mg and 360 mg	021392	1	2005-08-30
CARDIZEM LA	Extended-release Tablets	diltiazem hydrochloride	420 mg	021392	1	2005-04-25

US Patents and Regulatory Information for DILTIAZEM HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	203023-001	Jun 8, 2017		DISCN	No	No
Utopic Pharms	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	216304-003	Aug 8, 2022	AB2	RX	No	No
Macleods Pharms Ltd	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	218744-002	Feb 27, 2026	AB3	RX	No	No
Chartwell Rx	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	091022-005	Sep 28, 2012	AB4	RX	No	No
Rising	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	072838-003	Nov 5, 1992		DISCN	No	No
Chartwell Molecules	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	074093-004	Nov 5, 1992		DISCN	No	No
Teva	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	074079-002	Nov 30, 1993		DISCN	No	No

International Patents for DILTIAZEM HYDROCHLORIDE

See the table below for patents covering DILTIAZEM HYDROCHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2243092
Germany	69229949
Canada	2111085	FORMULATION DE DILTIAZEM A LIBERATION LENTE (EXTENDED-RELEASE FORM OF DILTIAZEM)
Denmark	0591424
World Intellectual Property Organization (WIPO)	9300093
European Patent Office	0591424	DILTIAZEM SE PRESENTANT SOUS UNE FORME A LIBERATION PROLONGEE (EXTENDED-RELEASE FORM OF DILTIAZEM)
Austria	184196

Investment Scenario and Fundamentals Analysis for Diltiazem Hydrochloride

Last updated: February 20, 2026

What is the Current Market Position of Diltiazem Hydrochloride?

Diltiazem hydrochloride is a calcium channel blocker used to treat hypertension, angina, and certain arrhythmias. It is available as a generic drug and branded formulations. The drug's global pharmaceutical sales reached approximately $2 billion in 2022, with a compound annual growth rate (CAGR) of 3.5% from 2018 to 2022 ([1]).

The drug maintains substantial market presence due to its well-established therapeutic profile, with regional variations. North America accounts for roughly 40% of sales, Europe approximates 25%, and Asia-Pacific constitutes 20%. The remaining 15% spreads across Latin America, Middle East, and Africa. Patents for original formulations expired around 2014–2015, leading to extensive generics competition.

What are the Key Market Drivers and Barriers?

Market Drivers

• Generic Availability: Wide patent expiration shifts revenue toward generics, increasing volume but reducing profit margins.
• Chronic Disease Prevalence: Rising hypertension and angina cases in aging populations sustain demand.
• Healthcare Access: Growing healthcare infrastructure in emerging markets expands reach.

Market Barriers

• Price Competition: Homogeneity among generics leads to downward pricing pressure.
• Regulatory Scrutiny: Stringent quality and bioequivalence standards restrict market entry or reformulation.
• Emerging Alternatives: Newer calcium channel blockers and combination therapies reduce reliance on traditional diltiazem.

What Are the Key Financial and Development Indicators?

• Market Revenue (2022): $2 billion globally.
• Growth Forecast (2023–2028): 3% CAGR.
• Generic Penetration: 80% of market share as of 2022.
• R&D Investment: Minimal for established formulations; focus on reformulations or combination drugs.

How Do Patent and Regulatory Environments Influence Investment?

Patent expirations for multiple formulations have led to widespread generic manufacturing. Regulatory pathways in major markets (FDA, EMA) facilitate approval of bioequivalent generic versions, maintaining stable, low margins. However, markets such as Japan and China exhibit higher barriers, including localized bioequivalence requirements and pricing controls, limiting profit potential.

What Are the Strategic Investment Considerations?

• Generic Manufacturing: Opportunities exist in low-cost production centers focusing on high-volume, low-margin sales.
• Formulation Innovation: Limited R&D needed for established formulations; potential for reformulations (e.g., sustained-release, combination drugs) targeting niche markets.
• Market Expansion: Emerging markets could present growth, contingent on navigating regulatory landscapes.

What are the Risks for Investment?

• Price Erosion: As more generics enter, declines in per-unit revenue occur.
• Regulatory Risks: Non-compliance or delays can impair market access.
• Competition: Intense competition from large, well-established generic players (e.g., Teva, Sun Pharma).

What Are the Opportunities for Differentiated Products?

Limited innovation exists for conventional diltiazem hydrochloride. However, reformulations such as extended-release forms or fixed-dose combinations could command premium pricing in targeted populations or indications. Entry into niche markets, such as combination therapy for resistant hypertension, remains a potential avenue.

Closing Summary

Diltiazem hydrochloride exhibits a mature but stable market dominated by generics. Investment prospects revolve around low-cost manufacturing, reformulation for niche indications, and expansion into emerging markets. Risks include declining margins due to price competition and regulatory hurdles.

Key Takeaways

• The global market for diltiazem hydrochloride is approximately $2 billion with steady growth.
• Market share is primarily held by generics; patent expirations have intensified price competition.
• Opportunities exist in formulation innovation and emerging markets, but profit margins are low.
• Regulatory and competitive risks remain significant factors influencing investment decisions.

FAQs

1. What is the outlook for generic diltiazem hydrochloride?
The market will remain stable with steady demand driven by chronic disease prevalence. Price pressures will persist due to extensive generic competition.

2. Are there high-growth segments within this drug's market?
Limited; growth may come from reformulated versions or fixed-dose combinations targeting specific patient populations.

3. How does patent status affect the market?
Patent expiration has led to widespread generic manufacturing, decreasing brand-name sales but increasing volume.

4. What regulatory factors influence investment in this drug?
Approval depends on bioequivalence standards and local market regulations, which vary regionally and can delay or restrict market entry.

5. What competitive strategies can companies pursue?
Focus on cost-efficient manufacturing, reformulations targeting niche indications, or geographic expansion into emerging markets.

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References

[1] GlobalData. (2023). Pharmaceutical sales database.