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. Three 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
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	8,778,393
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	8,574,189		Y
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	10,245,228		Y
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	8,226,978		Y
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	9,744,129		Y
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	11,676,691		Y
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	10,507,180		Y

International Patents for DSUVIA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	2612645
China	101730516	Storage and dispensing devices for adminsistration of oral transmucosal dosage forms
China	113143769	用于分配口腔经粘膜剂型的设备和方法 (APPARATUS AND METHODS FOR DISPENSING ORAL TRANSMUCOSAL DOSAGE FORMS)
South Korea	101503074
Japan	2010531153
China	108367105	用于分配口腔经粘膜剂型的设备和方法 (APPARATUS AND METHODS FOR DISPENSING ORAL TRANSMUCOSAL DOSAGE FORMS)
Japan	5349053

Supplementary Protection Certificates for DSUVIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2114383	122016000023	Germany		PRODUCT NAME: SUFENTANIL, WAHLWEISE IN FORM VON SUFENTANILCITRAT; REGISTRATION NO/DATE: EU/1/15/1042 20150918
2114383	SPC/GB16/004	United Kingdom		PRODUCT NAME: SUFENTANIL; REGISTERED: UK EU/1/15/1042 20150922
2114383	CA 2016 00007	Denmark		PRODUCT NAME: SUFENTANIL, HERUNDER SUFENTANIL SOM CITRAT; REG. NO/DATE: EU/1/15/1042/001-006 20150922
2114383	CR 2016 00007	Denmark		PRODUCT NAME: SUFENTANIL; REG. NO/DATE: EU/1/15/1042/001-006 20150922
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

Market Dynamics and Financial Trajectory for DSUVIA

Introduction

DSUVIA, a sublingual sufentanil tablet, was approved by the U.S. Food and Drug Administration (FDA) in November 2018 for the management of acute pain in adults in certified medically supervised healthcare settings. This article delves into the market dynamics and financial trajectory of DSUVIA, highlighting its unique features, market performance, and the impact of recent developments.

Unique Features and Approval

DSUVIA is a single-strength solid dosage form of sufentanil, administered sublingually via a single-dose applicator. Its approval was based on a phase-3 clinical trial that demonstrated its efficacy and safety in managing pain after ambulatory abdominal surgery[1][4].

Market Need and Target Audience

DSUVIA fills a critical need for patients who require rapid pain relief in settings where intravenous access is not available, such as hospitals, surgical centers, emergency departments, and even battlefield scenarios. This unique delivery method makes it an essential option for patients who cannot swallow oral medication[1][4].

FDA Approval and Regulatory Considerations

The FDA approval of DSUVIA came with strict regulations, including a Risk Evaluation and Mitigation Strategy (REMS) to control its distribution and use. This strategy aims to prevent misuse and abuse, reflecting the FDA's cautious approach to opioid products in the context of the opioid crisis[4].

Initial Market Performance

Following its approval, DSUVIA saw gradual market uptake. In the first quarter of 2022, AcelRx Pharmaceuticals reported that 10,530 units of DSUVIA were sold, representing an 18% increase from the previous quarter and a 64% increase excluding Department of Defense (DoD) revenues[2].

Financial Performance

The financial performance of DSUVIA has been modest but growing. For the full year 2022, DSUVIA net sales were $1.8 million, a 76% increase over the same period in 2021. However, AcelRx Pharmaceuticals faced operational challenges, with combined R&D and SG&A expenses totaling $8.7 million in the first quarter of 2022, leading to a net loss of $8.674 million for the same period[2][5].

Divestment to Alora Pharmaceuticals

In March 2023, AcelRx Pharmaceuticals announced the divestment of DSUVIA to Alora Pharmaceuticals. This agreement provides AcelRx with a 15% royalty on commercial sales and a 75% royalty on sales to the DoD. This move allows AcelRx to focus on other high-value development assets while continuing to benefit from DSUVIA's commercial success[3][5].

Impact of Divestment

The divestment marks a strategic shift for AcelRx, enabling the company to reduce operating expenses and focus on advancing its nafamostat and pre-filled syringe portfolio. For Alora Pharmaceuticals, the acquisition expands their pain management portfolio and ensures continued access to DSUVIA for patients in need[3].

Market Growth Potential

Despite the challenges associated with opioid products, DSUVIA's unique delivery mechanism and restricted use in medically supervised settings mitigate some of the risks. The growing demand for effective pain management solutions in specific healthcare settings suggests potential for continued market growth. The partnership with Alora Pharmaceuticals is expected to enhance the drug's distribution and accessibility[3][4].

Competitive Landscape

DSUVIA operates in a competitive opioid analgesic market, but its sublingual delivery and restricted use settings differentiate it from other products. The FDA's stringent regulations and the REMS program ensure that DSUVIA is used responsibly, which can help in maintaining its market position[4].

Future Outlook

The future outlook for DSUVIA is promising, particularly with the new partnership with Alora Pharmaceuticals. The focus on expanding its commercialization and ensuring continued access to patients in certified healthcare settings is likely to drive growth. Additionally, the royalties from commercial and DoD sales will provide a steady revenue stream for AcelRx Pharmaceuticals[3][5].

Key Takeaways

• Unique Delivery Mechanism: DSUVIA's sublingual delivery makes it ideal for patients who cannot swallow oral medication or access IV pain relief.
• Regulatory Oversight: Strict FDA regulations, including a REMS program, control its distribution and use.
• Market Performance: Gradual market uptake with significant growth in unit sales.
• Divestment: AcelRx Pharmaceuticals divested DSUVIA to Alora Pharmaceuticals, focusing on other development assets while retaining royalties.
• Growth Potential: Continued demand for effective pain management solutions in specific healthcare settings.

FAQs

What is DSUVIA and how is it administered?

DSUVIA is a sublingual sufentanil tablet administered via a single-dose applicator for the management of acute pain in adults in certified medically supervised healthcare settings.

What are the unique features of DSUVIA?

DSUVIA's unique feature is its sublingual delivery, making it suitable for patients who cannot swallow oral medication or access IV pain relief, particularly in settings like hospitals, surgical centers, and battlefield scenarios.

What were the key findings of the clinical trial that led to FDA approval?

The phase-3 clinical trial demonstrated that DSUVIA provided statistically greater summed pain intensity difference from baseline over the first 12 hours compared to placebo, with median meaningful pain relief occurring within 15 minutes.

How has the market performance of DSUVIA been since its approval?

DSUVIA has seen gradual market uptake, with unit sales growth of 18% in the first quarter of 2022 compared to the previous quarter, and a 76% increase in full-year 2022 sales over 2021.

What is the impact of the divestment of DSUVIA to Alora Pharmaceuticals?

The divestment allows AcelRx Pharmaceuticals to focus on other high-value development assets while retaining royalties from commercial and DoD sales, ensuring continued access to DSUVIA for patients and reducing operating expenses.

What are the future prospects for DSUVIA?

The future outlook is promising, with potential for continued market growth driven by the new partnership with Alora Pharmaceuticals and the steady revenue stream from royalties.

Sources

1. Aetna: Sufentanil Sublingual Tablet (Dsuvia) - Aetna.
2. PR Newswire: AcelRx Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Corporate Update.
3. PR Newswire: AcelRx Pharmaceuticals Announces Divestment of DSUVIA® to Alora Pharmaceuticals.
4. FDA: Statement from FDA Commissioner Scott Gottlieb, M.D., on agency's approval of Dsuvia and FDA's future consideration.
5. PR Newswire: AcelRx Pharmaceuticals Reports Full Year and Fourth Quarter 2022 Financial Results and Provides Corporate Update.