SERNIVO Drug Patent Profile

When do Sernivo patents expire, and when can generic versions of Sernivo launch?

Sernivo is a drug marketed by Primus Pharms and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has seven patent family members in five countries.

The generic ingredient in SERNIVO is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sernivo

A generic version of SERNIVO was approved as betamethasone dipropionate by FOUGERA PHARMS on June 26^th, 1984.

Summary for SERNIVO

International Patents:	7
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Patent Applications:	4,338
Drug Prices:	Drug price information for SERNIVO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SERNIVO
What excipients (inactive ingredients) are in SERNIVO?	SERNIVO excipients list
DailyMed Link:	SERNIVO at DailyMed

See drug prices for SERNIVO

See drug sales revenues for SERNIVO

Pharmacology for SERNIVO

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for SERNIVO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SERNIVO	Topical Spray	betamethasone dipropionate	0.05%	208079	1	2018-02-15

US Patents and Regulatory Information for SERNIVO

SERNIVO is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y

International Patents for SERNIVO

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3141246
Denmark	2473161
Japan	2013503203
World Intellectual Property Organization (WIPO)	2011026076
Spain	2637447
Japan	5833007

SERNIVO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sernivo

Introduction

Sernivo, a prescription topical steroid spray, has been a significant player in the dermatology market since its launch. Developed by Dr. Reddy's Laboratories and marketed by its US subsidiary, Promius Pharma, LLC, Sernivo is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. Here, we delve into the market dynamics and financial trajectory of Sernivo.

FDA Approval and Market Entry

In February 2016, Sernivo received approval from the US Food and Drug Administration (FDA) to market the 0.05% betamethasone dipropionate spray. This approval marked a significant milestone for Promius Pharma, highlighting their commitment to developing innovative treatment options in the dermatology space[4].

Market Positioning

Sernivo entered a market where topical steroids are a common treatment for psoriasis. Its differentiation lies in its spray formulation, which offers ease of application and patient compliance. This unique delivery system has been a key factor in its market acceptance and patient preference[4].

Competitive Landscape

The psoriasis treatment market is highly competitive, with various topical and systemic treatments available. However, Sernivo's spray formulation and its prescription status have helped it carve out a niche. The entry of generic versions, such as the one announced by Perrigo in 2019, has introduced competition but also validated the market demand for this formulation[1].

Financial Performance

Initial Launch and Revenue

Upon its launch, Sernivo contributed to the growth of Dr. Reddy's Laboratories' proprietary products segment. The company reported significant revenue growth from its North American operations, partly due to the success of Sernivo and other proprietary products. In FY2016, revenues from North America grew by 19% to ₹75.4 billion, with Sernivo being one of the key contributors[3].

Market Sales

As of February 2019, the annual market sales for Sernivo Spray were approximately $15 million, as measured by IQVIA. This figure indicates a steady market presence and revenue stream for the product[1].

Generic Competition

In April 2019, Perrigo announced the tentative FDA approval for the generic version of Sernivo Spray. This development is expected to impact the market dynamics, potentially reducing the market share and revenue of the branded version. However, the settlement terms between Perrigo and Promius Pharma remain confidential, which may influence the timing and extent of generic competition[1].

Impact on Dr. Reddy's Financials

Dr. Reddy's Laboratories has a diversified portfolio, which helps mitigate the impact of generic competition on any single product. The company's financial performance has been robust, with consolidated revenues growing across various geographies. For instance, in Q1 FY19, the company reported a 12% year-on-year growth in consolidated revenues, driven by strong performance in Russia and contributions from other products like the generic version of Suboxone film[5].

Revenue Streams

Sernivo is part of Dr. Reddy's proprietary products segment, which has been a focus area for the company. The segment's growth is driven by innovative products like Sernivo and Zembrace SymTouch, which are approved by the USFDA. These products contribute significantly to the company's revenue and profitability[3].

Market Expansion and Growth Strategies

Dr. Reddy's has been expanding its presence in key generics markets globally. The company's strategy includes strengthening its pipeline with complex generics, improving OTC offerings, and increasing its institutional and hospital business. These initiatives are expected to drive future growth and help the company navigate competitive pressures[3].

Industry Expert Insights

Raghav Chari, Executive Vice President of Proprietary Products and President of Promius Pharma, highlighted the company's commitment to developing innovative treatment options in the dermatology space. This commitment underscores the company's focus on differentiated drug delivery systems, such as the spray formulation of Sernivo[4].

Statistics and Market Data

• Revenue Growth: In FY2016, Dr. Reddy's revenues from North America grew by 19% to ₹75.4 billion, partly driven by Sernivo[3].
• Market Sales: As of February 2019, Sernivo Spray had annual market sales of approximately $15 million[1].
• Generic Competition: The tentative FDA approval for the generic version of Sernivo Spray by Perrigo in 2019 introduced a new competitor in the market[1].

Key Takeaways

• Innovative Formulation: Sernivo's spray formulation has been a key differentiator in the psoriasis treatment market.
• Market Acceptance: The product has seen steady market acceptance and revenue growth since its launch.
• Generic Competition: The entry of generic versions is expected to impact the market dynamics and revenue of the branded version.
• Diversified Portfolio: Dr. Reddy's diversified portfolio helps mitigate the impact of generic competition on any single product.
• Growth Strategies: The company's focus on complex generics, OTC offerings, and institutional business is expected to drive future growth.

FAQs

What is Sernivo used for?

Sernivo is a prescription topical steroid spray used for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

When did Sernivo receive FDA approval?

Sernivo received FDA approval in February 2016.

Who markets Sernivo in the US?

Sernivo is marketed by Promius Pharma, LLC, the US subsidiary of Dr. Reddy's Laboratories.

What is the unique feature of Sernivo?

The unique feature of Sernivo is its spray formulation, which offers ease of application and patient compliance.

How has generic competition affected Sernivo?

The tentative FDA approval for the generic version of Sernivo Spray by Perrigo in 2019 has introduced competition, which may reduce the market share and revenue of the branded version.

Sources

1. Perrigo Announces Tentative FDA Approval for the Generic Version of Sernivo® Spray, 0.05% - Perrigo Company plc.
2. Dr. Reddy's Labs - HDFC securities - HDFC Securities.
3. Annual Report 2016 - Dr. Reddy's Laboratories.
4. Dr Reddy's launches Sernivo spray in the US market - The Economic Times.
5. Dr. Reddy's Q1 FY 19 - Earnings Conference Call - Dr. Reddy's Laboratories.