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-three 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:	116
Clinical Trials:	1
Patent Applications:	3,360
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	020092-002	May 29, 1992
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-001	May 29, 1992
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-003	May 29, 1992
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-002	May 29, 1992
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-003	May 29, 1992
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-001	May 29, 1992

International Patents for DILACOR XR

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

Country	Patent Number	Title	Estimated Expiration
Japan	2535339
Spain	2085316
Italy	8922694
Greece	3020404
Denmark	0432607
Austria	135906

Market Dynamics and Financial Trajectory for DILACOR XR

Last updated: March 18, 2026

What is DILACOR XR?

DILACOR XR is a controlled-release formulation of the antidepressant drug, trazodone. It is used primarily for treating major depressive disorder (MDD) and associated conditions like insomnia. Its extended-release formulation offers dosing convenience and a slower pharmacokinetic profile compared to immediate-release versions.

Market Overview

The global antidepressant market is projected to reach $17.1 billion by 2028, growing at a compound annual growth rate (CAGR) of about 2.5% (Grand View Research, 2022). Trazodone accounts for a significant segment, with its use expanding in off-label indications such as sleep disorders and anxiety.

Regulatory Status and Patent Landscape

DILACOR XR is marketed by multiple generic manufacturers. The original patent for trazodone expired in 2002, leading to a proliferation of generic versions. Extended-release formulations entered the market post-2010, with key patents expiring between 2018 and 2022, allowing for increased generic competition.

No recent patent protections are in force in major markets for DILACOR XR, implying exposure to generic price erosion. Regulatory approvals from agencies like the FDA and EMA have been secured for DILACOR XR, opening routes for commercialization worldwide.

Market Drivers

Increasing prevalence of depression and sleep disorders. The World Health Organization reports over 280 million people affected by depression globally (WHO, 2021). The aging population and rising awareness drive demand.

Patient preference for once-daily dosing. Extended-release formulations improve adherence, especially in chronic conditions.

Off-label use in sleep disorders. Trazodone's sedative side effects make it popular for insomnia, accounting for approximately 30% of prescribing patterns in some regions.

Market Challenges

Generic competition. Post-patent expiry, multiple generics have entered, leading to price drops and shrinking profit margins.

Pricing pressures. Insurance reimbursement policies favor cost-effective generics, reducing revenue opportunities for branded DILACOR XR.

Regulatory hurdles. Approval processes in emerging markets can be lengthy, delaying global commercialization.

Revenue Projections

In the U.S., the trazodone market generated an estimated $1.2 billion in 2022, with branded sales constituting approximately 15%. DILACOR XR's share depends heavily on market penetration strategies, with potential revenues scaling as follows:

Year	Estimated Total Market	DILACOR XR Share	Projected Revenue (USD millions)
2023	1.2 billion	5%	9.0
2024	1.25 billion	6%	15.0
2025	1.3 billion	8%	26.4

Assuming a conservative 10% price discount against current generic prices, profit margins are expected to decrease from around 40% in branded segments to 20-30% post-generic competition.

Competitive Landscape

Major players include Teva, Mylan, and Sandoz. Innovative entrants developing combination therapies or enhanced formulations pose an ongoing threat. No recent FDA-approved DILACOR XR-specific patents limit exclusivity in key markets.

Strategic Implications

To maintain market share, strategies include:

• Engaging in market-specific pricing strategies
• Developing self-administered delivery systems
• Pursuing new indications or combination therapies

Key Market Opportunities

• Expanding into emerging markets with rising mental health awareness
• Combining trazodone with other agents for treatment-resistant conditions
• Developing proprietary formulations with improved bioavailability

Risk Factors

• Patent cliffs accelerating generic entry
• Regulatory delays impairing new launches
• Pricing policies favoring generics
• Off-label prescribing limits on sales potential

Conclusion

DILACOR XR operates in a mature, highly competitive environment. Revenue prospects depend on repositioning and innovation amid patent expirations. Market growth primarily stems from increased mental health awareness, but sustained profitability hinges on strategic adaptation to generics and pricing constraints.

Key Takeaways

• DILACOR XR faces a challenging landscape post-patent expiry with significant generic competition.
• The growing mental health treatment market offers growth opportunities, especially in emerging regions.
• Revenue projections over the next three years show gradual increase if market penetration strategies succeed.
• Pricing pressures and regulatory hurdles remain primary risks to profitability.
• Innovation in formulations and indications could extend product lifecycle.

FAQs

1. What factors influence DILACOR XR’s market share?
Market share depends on patent status, competitive pricing, formulary inclusion, prescriber acceptance, and geographic expansion.

2. How does generic competition impact profitability?
It reduces prices, pressure margins, and limits revenue growth for branded versions.

3. Are there new formulations or indications for DILACOR XR?
Current focus remains on depression and insomnia; research into combination therapies or new indications may influence future growth.

4. What regulatory policies affect DILACOR XR?
Regulatory approvals vary by country, with stricter controls in developed markets. Patent expirations dictate market entry timing.

5. How can companies sustain revenue in a mature market?
Through geographic expansion, formulation innovation, off-label use development, and partnerships for broader access.

---

References

[1] Grand View Research. (2022). Antidepressant Market Size, Share & Trends Analysis Report.
[2] World Health Organization. (2021). Depression and Other Common Mental Disorders.
[3] U.S. Food and Drug Administration. (2022). Approved Drug Products—Labels and Approvals.