UPNEEQ Drug Patent Profile

Which patents cover Upneeq, and when can generic versions of Upneeq launch?

Upneeq is a drug marketed by Rvl Pharms and is included in one NDA. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-nine countries.

The generic ingredient in UPNEEQ is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Upneeq

Indicators of Generic Entry

Summary for UPNEEQ

International Patents:	53
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	2
Patent Applications:	1,992
What excipients (inactive ingredients) are in UPNEEQ?	UPNEEQ excipients list
DailyMed Link:	UPNEEQ at DailyMed

Recent Clinical Trials for UPNEEQ

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

Sponsor	Phase
Milton S. Hershey Medical Center	Phase 3
University of Miami	Phase 4

See all UPNEEQ clinical trials

Pharmacology for UPNEEQ

Drug Class	Vasoconstrictor
Physiological Effect	Increased Sympathetic Activity Vasoconstriction

US Patents and Regulatory Information for UPNEEQ

UPNEEQ is protected by twelve US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes

International Patents for UPNEEQ

When does loss-of-exclusivity occur for UPNEEQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

European Patent Office

Israel

Japan

Mexico

Morocco

New Zealand

Peru

Singapore

South Africa

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering UPNEEQ around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101889392
Chile	2021002918	Composiciones y métodos de oximetazolina para el tratamiento de trastornos oculares
Hungary	E046740

Market Dynamics and Financial Trajectory for UPNEEQ

Introduction to UPNEEQ

UPNEEQ, a product of RVL Pharmaceuticals plc, is a treatment for acquired blepharoptosis, or low-lying eyelids. It has been making significant waves in both the eye care and medical aesthetics markets since its launch.

Market Context

Medical Aesthetics Market

The global medical aesthetics market is a burgeoning sector, estimated to be over $100 billion annually, with demand growing at double-digit percentages. Regions in Asia and South America are particularly driving this growth, alongside a well-established market in North America[3].

Unique Selling Proposition

UPNEEQ stands out as it is classified as a medicine rather than a procedure, raising the eyelids without the need for surgical intervention. This unique positioning sets it apart from other aesthetic treatments like Botox, Latisse, QWO, and Sculptra[3].

Launch and Expansion

Entry into Medical Aesthetics

RVL Pharmaceuticals launched UPNEEQ into the medical aesthetics market in February 2022. This move significantly expanded the product's reach beyond its initial focus on eye care. By the end of 2022, approximately 4,300 new customer practices had ordered UPNEEQ, indicating strong market acceptance[1][2].

Sales Team Expansion

To support this growth, RVL Pharmaceuticals expanded its aesthetics sales team, achieving sales coverage in about 70 territories by the end of 2022. This strategic expansion helped in penetrating deeper into the market[1].

Telemedicine Channel

The company also opened a telemedicine channel in the third quarter of 2022, further enhancing accessibility and convenience for patients. This move aligns with the growing trend of telehealth services[1].

Financial Performance

Fourth Quarter 2022 Financial Highlights

• UPNEEQ net product sales for the fourth quarter of 2022 were $9.8 million, a 216% increase from $3.1 million in the fourth quarter of 2021. This growth was driven by higher sales volumes[1][2].
• The loss from continuing operations was $(18.3) million, with an adjusted EBITDA loss of $(9.3) million, which is an improvement of $5.9 million compared to the fourth quarter of 2021[1][2].

Full Year 2022 Financial Results

• Full-year 2022 UPNEEQ net product sales were $34.2 million, a 356% increase from $7.5 million in 2021. Total revenues for the year were $49.7 million, up 184% from $17.5 million in 2021[1][2].
• The loss from continuing operations for the full year was $(51.7) million, with an adjusted EBITDA loss of $(50.9) million, an improvement of $9.8 million compared to 2021[1][2].

Cash and Debt Position

As of December 31, 2022, RVL Pharmaceuticals had $44.5 million in cash and cash equivalents and long-term debt of $75.0 million. This financial position indicates a robust cash reserve to support ongoing operations and debt obligations[1][2].

Sales and Revenue Breakdown

Net Product Sales

The significant increase in UPNEEQ net product sales can be attributed to the expanded commercialization into both eye care and medical aesthetics markets. For the fourth quarter of 2022, net product sales increased by $6.7 million to $9.8 million compared to the same period in 2021[1][2].

Licensing Revenue

Total revenues also benefited from higher licensing revenue from Santen, particularly in the first quarter of 2022. However, there was no licensing revenue in the first quarter of 2023, which affected the overall revenue comparison[5].

Customer and Prescriber Base

Unique Prescribers

By the end of 2022, RVL Pharmaceuticals had surpassed the milestone of 20,000 cumulative unique pharmacy-paid prescribers. This number increased to approximately 19,900 by the end of the first quarter of 2023, reflecting continued growth in the prescriber base[1][5].

Medical Aesthetics Practices

The number of cumulative unique medical aesthetics practices ordering UPNEEQ grew to about 4,800 by the end of the first quarter of 2023, up 12% from the end of 2022[5].

Operational Efficiency

Gross Profit Percentage

The gross profit percentage from net product sales was 74% for the fourth quarter of 2022, compared to 58% in the same period of 2021. This improvement is due to higher volumes and more favorable average selling prices[1][2].

Cost of Goods Sold

The total cost of goods sold increased by $1.5 million to $2.6 million in the fourth quarter of 2022, primarily driven by higher sales volumes. This increase reflects the operational efficiency in managing higher production and distribution demands[1][2].

Future Outlook

Revenue Recognition Adjustment

A notable adjustment was made to the revenue recognition methodology, where $2.3 million of net product sales initially included in the fourth quarter and full-year 2022 estimates will now be recognized in the first quarter of 2023. This change does not impact management’s expectations for future growth of UPNEEQ[1][2].

Market Expansion

RVL Pharmaceuticals is poised for further growth through collaborations, such as the partnership with Santen for markets in Asia, EMEA, and Canada. Clinical trials have begun in Asia, indicating a strong potential for international expansion[3].

Key Takeaways

• Strong Market Entry: UPNEEQ's launch into the medical aesthetics market in February 2022 was highly successful, with significant year-over-year growth.
• Expanded Sales Coverage: The company expanded its sales team and opened a telemedicine channel, enhancing market penetration.
• Financial Growth: UPNEEQ net product sales and total revenues saw substantial increases in 2022, driven by higher sales volumes and licensing revenue.
• Operational Efficiency: Improved gross profit percentages and efficient cost management reflect the company's operational strengths.
• Future Prospects: With a robust cash position, ongoing international expansion, and a unique product offering, UPNEEQ is well-positioned for continued growth.

FAQs

Q: What is UPNEEQ used for?

UPNEEQ is used for the treatment of acquired blepharoptosis, or low-lying eyelids.

Q: How did UPNEEQ perform in the fourth quarter of 2022?

UPNEEQ net product sales were $9.8 million in the fourth quarter of 2022, a 216% increase from the same period in 2021.

Q: What was the total revenue for RVL Pharmaceuticals in 2022?

Total revenues for RVL Pharmaceuticals in 2022 were $49.7 million, an increase of 184% from 2021.

Q: How many unique prescribers have ordered UPNEEQ?

By the end of the first quarter of 2023, approximately 19,900 cumulative unique pharmacy-paid prescribers had ordered UPNEEQ.

Q: What is the outlook for UPNEEQ's international expansion?

RVL Pharmaceuticals is expanding UPNEEQ's reach through partnerships, such as with Santen for markets in Asia, EMEA, and Canada, with clinical trials already underway in Asia.

Sources

1. RVL Pharmaceuticals plc Reports Fourth Quarter and Full Year 2022 Financial Results Provides Commercial Update - Biospace
2. RVL Pharmaceuticals plc Reports Fourth Quarter and Full Year 2022 Financial Results Provides Commercial Update - GlobeNewswire
3. Zacks Small-Cap Research - Zacks Investment Research
4. Osmotica Pharmaceuticals plc Announces Corporate Name Change to RVL Pharmaceuticals plc New Ticker Symbol RVLP Plans to Launch UPNEEQ into the Medical Aesthetics Market and Provides Fourth Quarter 2022 Net Sales Guidance - Biospace
5. RVL Pharmaceuticals Reports First Quarter 2023 Financial Results Provides Commercial Update - Citybiz.co