DALMANE Drug Patent Profile

Which patents cover Dalmane, and what generic alternatives are available?

Dalmane is a drug marketed by Valeant Pharm Intl and is included in one NDA.

The generic ingredient in DALMANE is flurazepam hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the flurazepam hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dalmane

A generic version of DALMANE was approved as flurazepam hydrochloride by RISING on November 27^th, 1985.

Summary for DALMANE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for DALMANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Investment Scenario and Fundamentals Analysis for DALMANE (Alvimopan)

Last updated: February 20, 2026

What is DALMANE?

DALMANE is the brand name for alvimopan, a peripherally acting mu-opioid receptor antagonist designed to reduce postoperative ileus (POI). It is primarily used to accelerate gastrointestinal recovery following bowel resection surgeries.

Current Market Position

• Approved indications in the United States (FDA, 2008); limited approval in other regions.
• Patent status: Original patent expired, with some secondary patents possibly still active.
• Commercialization: Sold under the DALMANE brand by specialty pharmaceutical companies; dosage and administration routes are well established.

Market Dynamics

Market Size and Growth

• The global postoperative nausea and vomiting market estimated at USD 2.3 billion (2022).
• Poised to grow at a compound annual growth rate (CAGR) of 6.2% through 2030 (Research, 2022).
• Exact size of the POI segment is smaller, estimated at USD 400 million globally, with some overlap in surgical recovery drugs.

Drivers

• Rising volume of bowel surgeries globally due to aging populations.
• Growing adoption in hospitals aiming to reduce length of stay and improve recovery times.
• Enhanced awareness of POI complications, including costs exceeding USD 10,000 per case.

Barriers

• Limited approval outside the US restricts market access.
• Competition from other prokinetic agents or surgical recovery protocols.
• Physician familiarity and cost considerations.

Patent and Regulatory Landscape

Aspect	Details	Impact
Original patent expiration	Around 2014 (can vary by jurisdiction)	Patent expiry, generic entry possible
Secondary patents	Some protection possible until 2024–2026	Limited period of exclusivity remaining
Regulatory approvals	FDA approved in 2008; EMA approval status varies	Market access limited outside US

Financial and Commercial Fundamentals

Pricing and Revenue Estimates

• Typical per-dose price estimated at USD 250–350.
• Average dosing regimen: 12 mg preoperatively, with possible follow-up doses.
• Revenue potential per hospital depends on surgical volume and hospital adoption rates.

Cost Structure

• Manufacturing costs: Low, due to synthesis simplicity.
• Development costs: High, due to extensive clinical trials and regulatory filings.
• Marketing and distribution costs: Moderate, focusing on hospital and surgical centers.

Competitor and Pipeline Analysis

Competitors	Status	Market share	Notes
Methylnaltrexone (Relistor)	Approved, off-label use in GI	Growing	Focus on opioid-induced constipation
Naldemedine (Symproic)	Approved in GI indications	Limited	Similar mechanism, different niche
New pipeline agents	Several in early-stage trials	Unknown	Emerging therapies for GI recovery

Pipeline Outlook

• Limited late-stage pipeline specifically targeting POI.
• Potential for drug repurposing or combination treatments.
• Emerging interest from biotech firms in beneficial gut motility agents.

Investment View

Strengths

• DAAlMANE has established clinical efficacy and FDA approval.
• Growing surgical volumes support sustained demand.
• Lower manufacturing costs provide margin potential.

Weaknesses

• Patent expiration reduces exclusivity.
• Regional regulatory access is limited.
• Competition from general prokinetic drugs and surgical protocols.

Opportunities

• Expansion into international markets via partnerships.
• Development of new formulations or combination therapies.
• Potential label expansion for other gastrointestinal motility disorders.

Threats

• Patent cliffs, generic competitors.
• Regulatory setbacks or restrictions.
• Shifts in surgical practices favoring alternative recovery protocols.

Key Takeaways

DALMANE's market is characterized by its FDA-approved efficacy in reducing postoperative ileus, but patent expiration and regional approval limitations pose risks. The drug benefits from increasing surgical procedures and hospital efforts to shorten recovery times, yet faces competition and generic threat. Its financial potential hinges on market expansion, price management, and pipeline development.

FAQs

1. What is the current patent status of DALMANE?
   The original patent expired around 2014, with secondary patents possibly covering specific formulations or uses expiring between 2024 and 2026.

2. What are the key competitive advantages of DALMANE?
   Its proven clinical efficacy in reducing postoperative ileus and FDA approval serve as major advantages.

3. Are there regulatory barriers to expanding DALMANE's use internationally?
   Yes, approval outside the US varies; some regions have not approved alvimopan, limiting market potential.

4. What are the main competitive threats?
   Generic versions post-patent expiry and alternative postoperative recovery protocols.

5. What is the future pipeline outlook for DALMANE or analogous drugs?
   Limited late-stage pipeline specific to POI; potential in drug repurposing or combination treatments.

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References

[1] FDA. (2008). NDA 022171—ALVIMOPAN (DALMANE) Labeling and Approval Documentation.
[2] Market Research Future. (2022). Postoperative Nausea and Vomiting Market Report.
[3] GlobalData. (2023). Gastrointestinal Drugs Market Analysis.