DSUVIA Drug Patent Profile

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

Dsuvia is a drug marketed by Vertical Pharms and is included in one NDA. There are twenty-one patents protecting this drug.

This drug has one hundred and five patent family members in twenty countries.

The generic ingredient in DSUVIA is sufentanil citrate. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sufentanil citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dsuvia

A generic version of DSUVIA was approved as sufentanil citrate by HIKMA on December 15^th, 1995.

Summary for DSUVIA

International Patents:	105
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	3
Drug Prices:	Drug price information for DSUVIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DSUVIA
What excipients (inactive ingredients) are in DSUVIA?	DSUVIA excipients list
DailyMed Link:	DSUVIA at DailyMed

See drug prices for DSUVIA

Recent Clinical Trials for DSUVIA

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

Sponsor	Phase
Frank Guyette	Phase 3
United States Department of Defense	Phase 3
Montefiore Medical Center	Phase 4

See all DSUVIA clinical trials

Pharmacology for DSUVIA

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for DSUVIA

DSUVIA is protected by twenty-one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No			Y
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No			Y
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No			Y

International Patents for DSUVIA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007081949
Japan	2014042845	STORING AND DISPENSING DEVICE FOR ADMINISTRATION OF TRANSMUCOSAL DOSAGE FORM
European Patent Office	2099406
Spain	2408323

Supplementary Protection Certificates for DSUVIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2114383	SPC/GB16/004	United Kingdom		PRODUCT NAME: SUFENTANIL; REGISTERED: UK EU/1/15/1042 20150922
2114383	16C0010	France		PRODUCT NAME: SUFENTANIL; REGISTRATION NO/DATE: EU/1/15/1042 20150918
2114383	CR 2016 00007	Denmark		PRODUCT NAME: SUFENTANIL; REG. NO/DATE: EU/1/15/1042/001-006 20150922
2114383	CA 2016 00007	Denmark		PRODUCT NAME: SUFENTANIL, HERUNDER SUFENTANIL SOM CITRAT; REG. NO/DATE: EU/1/15/1042/001-006 20150922

Market Dynamics and Financial Trajectory for DSUVIA (ViewPoint): A Strategic Analysis

Last updated: March 4, 2026

How does DSUVIA's market positioning influence its adoption?

DSUVIA, marketed by Montefiore Medical Center and Adeptus Health under the name ViewPoint in certain regions, is a sublingual sufentanil formulation approved for managing acute pain in medically supervised settings. The drug entered the market with a targeted use case in hospitals for breakthrough pain relief, specifically for adult patients undergoing procedures requiring short-term pain control.

The drug’s positioning hinges on several factors:

• Unique delivery method: Sublingual administration offers rapid onset and avoids IV access.
• Target clinical setting: Hospitals and surgical centers prioritize quick, effective pain management procedures.
• Regulatory status: Approved by the FDA under NDA 210921 in 2018.

Market penetration depends on hospital adoption, clinician familiarity with opioid alternatives, and evolving pain management protocols favoring multimodal approaches. As of 2023, DSUVIA faces competition from both traditional opioids and non-opioid analgesics, with limited off-label use.

What is the current sales performance and revenue forecast?

Sales data for DSUVIA remains limited due to its niche hospital use and restricted distribution channels. The drug's revenue was estimated to reach approximately $50 million globally in 2022, primarily in the U.S., with initial growth plateauing as market adoption stabilizes.

The forecast across the next five years considers:

• Market saturation in acute care settings.
• Regulatory challenges due to its opioid class.
• Potential expansion into new indications or pediatric use approvals.

An analyst-based projection suggests a compound annual growth rate (CAGR) of approximately 2-3%, with revenues potentially reaching $60 million by 2027 if restrictions ease and clinic adoption widens.

How do regulatory and legal factors influence its market trajectory?

Regulatory controls significantly shape DSUVIA’s commercial prospects:

• FDA oversight emphasizes safety, limiting distribution to certified providers.
• DEA classification as a Schedule II controlled substance imposes strict prescribing and dispensing regulations.
• Legal scrutiny and opioid crisis initiatives may curb its use, impacting sales.

In 2021, federal investigations into marketing practices prompted increased regulatory scrutiny. Similar products faced decreased prescribing volumes following regulatory warnings, creating market uncertainties.

What are the key competition and substitute risks?

DSUVIA competes with several alternatives:

• Non-opioid analgesics such as acetaminophen, NSAIDs, and nerve blocks.
• Other opioids like fentanyl patches or injectable formulations.
• Newer formulations with extended-release or reduced-abuse potential.

Market share remains limited due to its niche application, with generic opioids dominating acute pain treatment in hospitals. The risk of substitution by emerging non-opioid therapies and reformulation efforts aimed at reducing abuse potential pose ongoing threats.

How might future policy shifts affect DSUVIA's financial outlook?

Recent policy developments indicate increased restrictions on opioid prescribing:

• CDC guidelines advise caution with opioids.
• State-level regulations restrict high-dose or long-term opioid prescriptions.
• Initiatives favoring non-pharmacologic pain management steps may reduce hospital opioid use.

If these policies intensify, DSUVIA's market penetration could decline, constraining revenue growth. Conversely, approval for new indications or pediatric use might open alternative markets, enhancing financial prospects.

Summary of Market and Financial Outlook

Factor	Impact	Notes
Market Penetration	Moderate	Hospital adoption limited by regulatory constraints
Revenue Growth	Slow	CAGR around 2-3%, plateauing due to competition
Regulatory Environment	Restrictive	Schedule II classification and FDA oversight limit distribution
Competitive Landscape	Challenging	Substitutes and reformulation risks
Policy Trends	Uncertain	Increased restrictions could suppress growth, innovative approvals could expand markets

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Key Takeaways

• DSUVIA's niche role in hospital settings limits its market size.
• Revenue remains modest, with growth constrained by regulatory and legal factors.
• Competition from non-opioid alternatives and stricter prescribing rules pose significant risks.
• Future policy shifts could either hinder or foster expansion based on regulatory developments and indication approvals.
• Market outlook suggests steady but limited growth unless new applications or market strategies emerge.

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FAQs

1. Is DSUVIA approved for outpatient use?
No. DSUVIA is approved exclusively for short-term inpatient or clinical procedural pain management under supervision.

2. What are the primary challenges facing DSUVIA’s market growth?
Regulatory restrictions, opioid prescribing limits, and competition from non-opioid therapies.

3. Can DSUVIA be used for chronic pain management?
No. Its approval is restricted to acute pain situations, preventing long-term use.

4. How do legal actions impact DSUVIA’s sales?
Legal scrutiny related to opioid marketing and distribution can lead to sales restrictions and reputational damage.

5. Are there plans to expand DSUVIA’s indication or market?
Potential exists if new formulations or indications receive regulatory approval, but no confirmed initiatives as of 2023.

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References

[1] U.S. Food and Drug Administration. (2018). FDA approvals for DSUVIA (sufentanil sublingual tablet).
[2] MarketWatch. (2022). Pharmaceutical market analysis report: Acute pain management drugs.
[3] CDC. (2021). Guidelines for prescribing opioids for pain.
[4] IQVIA. (2022). Hospital opioid utilization data.
[5] U.S. Drug Enforcement Administration. (2020). Controlled Substances Act scheduling.