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 HOSPIRA on December 11^th, 1996.

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
European Patent Office	2099406	Dispositifs de stockage et de distribution destinés à l'administration de formes pharmaceutiques transmucosiques orales (Storage and dispensing devices for administration of oral transmucosal dosage forms)
Japan	5876024
Japan	2010532745
Morocco	52369

Supplementary Protection Certificates for DSUVIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2114383	16C0010	France		PRODUCT NAME: SUFENTANIL; REGISTRATION NO/DATE: EU/1/15/1042 20150918
2114383	300797	Netherlands		PRODUCT NAME: SUFENTANIL, DESGEWENST IN DE VORM VAN SUFENTANILCITRAAT; REGISTRATION NO/DATE: EU/1/15/1042 20150922
2114383	CR 2016 00007	Denmark		PRODUCT NAME: SUFENTANIL; REG. NO/DATE: EU/1/15/1042/001-006 20150922
2114383	SPC/GB16/004	United Kingdom		PRODUCT NAME: SUFENTANIL; REGISTERED: UK EU/1/15/1042 20150922

DSUVIA Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

DSUVIA (sufentanil sublingual tablets) is a tightly controlled opioid product with a market shaped more by REMS enrollment, payor restrictions, and controlled-substance compliance than by classic brand/indication expansion. Financial trajectory is dominated by: (1) the size of peri-procedural and post-acute pain demand pools where sufentanil is substituted, (2) formulary access and net pricing through government and commercial channels, and (3) litigation, diversion controls, and opioid-supply oversight that raise operating costs and constrain uptake.

What is DSUVIA, and where does it sell?

DSUVIA is a branded formulation of sufentanil delivered as sublingual tablets intended for acute pain management in controlled clinical settings (commonly described for use in adult patients requiring opioid analgesia when close monitoring is feasible). The product is subject to U.S. opioid controls and is typically positioned within peri-procedural care pathways rather than chronic pain.

Indications and practical demand drivers

DSUVIA’s demand base is constrained by:

• Clinical setting fit: use cases tied to short-duration analgesia in monitored environments.
• Restricted prescribing and dispensing realities: workflow integration with controlled-substance handling.
• Regulatory and compliance friction: REMS-like operational expectations and heightened scrutiny for opioids.

How do regulation and controls shape market dynamics?

DSUVIA is an opioid. That fact drives structural market behavior that differs from non-controlled analgesics and most non-opioid brands.

Controlled-substance economics

Controlled-substance status affects DSUVIA’s market in four repeatable ways:

1. Institution-level buying rules (policy gating, formulary placement, and controlled-substance storage requirements).
2. Dispensing channel discipline (inventory management, audit readiness, loss prevention, and strict lot tracking).
3. Coverage tightening by PBMs and government programs during opioid stewardship cycles.
4. Faster reputational risk transfer from the broader opioid class to individual products, even when clinical risk management is strong.

Litigation and government oversight impact pricing power

The U.S. opioid landscape has repeatedly produced:

• heightened diligence by distributors and hospitals,
• stronger contracting terms for opioid brands,
• slower adoption where payer scrutiny increases.

Even when DSUVIA retains a clinical niche, the market typically behaves like a managed access product rather than a high-growth blockbuster.

What do market benchmarks imply for DSUVIA’s unit and revenue trajectory?

Without publishing DSUVIA’s private company-specific revenue line items in this input, the only defensible market-trajectory framing is through public product-market mechanics that correlate strongly with DSUVIA’s category:

Key market mechanics that determine DSUVIA revenue

1) Substitution pressure within acute pain DSUVIA competes against:

• other opioid delivery approaches used in monitored settings,
• alternatives where institutional protocols prefer different agents or administration routes.

In opioid acute-care windows, brands win by matching protocol preferences and clinician familiarity, not by broad consumer demand.

2) Net price is more important than headline list price Opioid products typically show:

• payor contracting variability,
• rebates and discounts driven by volume and stewardship.

The financial trajectory tends to follow net price and access more than growth in underlying procedure counts.

3) Adoption depends on compliance capacity A hospital does not buy DSUVIA in isolation. It buys into a pathway that includes:

• controlled-substance procedures,
• staff training,
• inventory and accountability systems.

That raises the marginal cost of adoption and slows switching.

Where does DSUVIA sit in the payer landscape?

DSUVIA’s payer dynamics are shaped by opioid stewardship and coverage controls.

Commercial coverage behavior

For branded opioids used for acute pain:

• formularies often restrict to preferred agents,
• prior authorization or step therapy appears more frequently than in non-controlled analgesics,
• contracts can include tighter utilization management.

Government channel behavior

Medicaid and Medicare coverage behavior depends on:

• hospital-based reimbursement structures,
• pharmacy benefit rules where applicable,
• opioid stewardship policies in participating systems.

These channels tend to:

• pressure net pricing,
• reduce adoption where there is an equivalent protocol choice.

What is the financial trajectory pattern for DSUVIA-like opioid brands?

In managed access opioid brands, the common financial pattern is:

• Early plateau after launch as clinicians learn protocol fit.
• Slow growth or decline depending on formulary and institutional substitution.
• Volatility driven by compliance scrutiny, litigation headlines, and payer contracting cycles rather than demand shocks.

For DSUVIA specifically, the trajectory should be interpreted as a function of:

• access persistence (staying on formularies and protocols),
• contracting terms and utilization guardrails,
• replacement risk from competing opioid formulations and protocol changes.

What are the main upside and downside levers?

Upside levers

• Protocol inclusion in hospital acute pain pathways where sublingual administration reduces workflow friction versus alternatives.
• Formulary persistence driven by clinician outcomes and operational fit.
• Contracting stability that supports net pricing.

Downside levers

• Substitution by competing opioids or delivery systems that gain preference under stewardship protocols.
• Payer restriction tightening that reduces patient-level coverage or institutional purchasing.
• Compliance and diversion-related friction that increases total acquisition cost and slows adoption.

How do supply chain and controlled-substance logistics affect margins?

Controlled-substance logistics drive incremental costs that can compress margins:

• inventory carrying and loss prevention,
• audit readiness,
• distributor and hospital compliance steps.

In this category, margin trajectory can deteriorate even if gross sales hold when:

• contracting squeezes net price,
• logistics and compliance costs increase.

What should investors or R&D leaders watch next?

Even without a line-by-line DSUVIA financial statement in this input, the next observable checkpoints are:

Commercial and access milestones

• formulary additions or removals at large IDNs (integrated delivery networks),
• shifts in PBM coverage criteria for acute pain opioid agents,
• changes to utilization management rules.

Regulatory and litigation-related operating cost signals

• enforcement intensity around opioid distribution and diversion,
• changes in corporate compliance costs,
• settlement or legal-cost accrual patterns for opioid brands in the market.

Competitive landscape shifts

• entry or expanded utilization of competing sufentanil formulations or alternative opioid delivery systems,
• protocol guideline updates at hospital-system level.

Key Takeaways

• DSUVIA’s market is managed-access, not open-demand. Controlled-substance rules, hospital protocol fit, and payer contracting drive uptake more than pure clinical efficacy claims.
• Financial trajectory is likely to follow net pricing and formulary access stability with slower growth and higher volatility risk than non-controlled analgesics.
• Margin is sensitive to compliance and logistics costs, which can rise even when unit demand is steady.
• Upside comes from sustained institutional protocols and contracting stability. Downside comes from substitution and payer restrictions.

FAQs

1. Is DSUVIA a blockbuster-style growth product?
   No. Its growth is constrained by controlled-substance compliance, institutional protocol fit, and payor access.

2. What determines DSUVIA’s revenue more: demand volume or net price?
   Net price and access persistence typically dominate, because controlled-substance products face contracting and stewardship-driven restrictions.

3. How does competition affect DSUVIA?
   Competition affects DSUVIA through protocol substitution and formulary preference shifts, which can reduce utilization even if the clinical category remains stable.

4. What operational factors can pressure DSUVIA margins?
   Compliance, inventory control, and distribution logistics increase operating costs in controlled-substance categories.

5. What observable events best signal DSUVIA trajectory direction?
   Hospital formulary changes, PBM coverage updates, and controlled-substance enforcement or policy shifts are leading indicators.

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References

[1] U.S. Food and Drug Administration. “Opioid REMS,” Drug Safety-related information. FDA website.
[2] FDA. “Drug Safety Communications and related opioid enforcement and stewardship updates,” FDA website.
[3] DEA. “Controlled Substances Act and related diversion control requirements,” Drug Enforcement Administration.