SILENOR Drug Patent Profile

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

Silenor is a drug marketed by Currax and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in four countries.

The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Silenor

A generic version of SILENOR was approved as doxepin hydrochloride by MYLAN PHARMS INC on May 13^th, 1986.

Summary for SILENOR

International Patents:	16
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	2
Patent Applications:	1,097
Drug Prices:	Drug price information for SILENOR
Drug Sales Revenues:	Drug sales revenues for SILENOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SILENOR
What excipients (inactive ingredients) are in SILENOR?	SILENOR excipients list
DailyMed Link:	SILENOR at DailyMed

See drug prices for SILENOR

See drug sales revenues for SILENOR

Recent Clinical Trials for SILENOR

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

Sponsor	Phase
University of Balamand	Phase 4
Currax Pharmaceuticals	Phase 4
Henry Ford Hospital	Phase 4

See all SILENOR clinical trials

Pharmacology for SILENOR

Drug Class

Tricyclic Antidepressant

Paragraph IV (Patent) Challenges for SILENOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SILENOR	Tablets	doxepin hydrochloride	3 mg and 6 mg	022036	2	2010-09-16

US Patents and Regulatory Information for SILENOR

SILENOR is protected by sixteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	AB	RX	Yes	Yes			Y
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	AB	RX	Yes	Yes
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	AB	RX	Yes	Yes
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	AB	RX	Yes	No
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	AB	RX	Yes	Yes
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	AB	RX	Yes	Yes

Expired US Patents for SILENOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	5,866,166
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	5,502,047
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	5,948,438
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	6,217,909
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	5,948,438
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	5,502,047

International Patents for SILENOR

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

Country	Patent Number	Title	Estimated Expiration
Norway	321771
Canada	2721133	FORMULATIONS DE DOXEPINE A FAIBLE DOSE ET PROCEDE DE PREPARATION ET D'UTILISATION DE CELLE-CI (LOW-DOSE DOXEPIN FORMULATIONS AND METHODS OF MAKING AND USING THE SAME)
Spain	2199281
Germany	69638015
European Patent Office	1287823	Excipient pharmaceutique à compressibilité améliorée (Pharmaceutical excipient having improved compressibility)
Norway	963732

SILENOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Silenor

Introduction

Silenor, a low-dose oral tablet formulation of doxepin, is a significant player in the treatment of insomnia characterized by frequent nocturnal awakenings and early morning awakenings. Here, we delve into the market dynamics and financial trajectory of Silenor, highlighting its performance, market drivers, and future prospects.

Market Drivers

The demand for Silenor is driven by several key factors:

Growing Prevalence of Insomnia

Insomnia is a widespread sleep disorder, and its increasing prevalence is a major driver for the demand of drugs like Silenor. The drug's efficacy in maintaining sleep, particularly into the later hours of the night, makes it a preferred treatment option[4].

Regulatory Approvals

Silenor has received approvals from regulatory bodies such as Health Canada, which has expanded its market reach beyond the United States. This approval has been crucial in increasing its global presence[4].

Clinical Efficacy

Clinical trials have demonstrated Silenor's ability to maintain sleep without significant next-day residual effects, making it a safe and effective treatment for insomnia. This clinical efficacy has contributed to its market acceptance[4].

Financial Performance

The financial performance of Silenor is closely tied to the overall performance of its parent companies and licensees.

Revenue Growth

Under Pernix Therapeutics, Silenor showed significant revenue growth. For instance, in the third quarter of 2014, Silenor's weekly prescriptions increased by more than 30% since the promotion began in May 2014. This growth was part of the overall strong performance of Pernix Therapeutics' specialty brands, including TREXIMET and Silenor[2].

Quarterly and Annual Sales

In the second quarter of 2016, Silenor generated $4.2 million in net sales, which was a $0.6 million increase from the first quarter of 2016. However, this was a decline from the $6.0 million in the same period in 2015. Despite this, Silenor remained a key contributor to Pernix Therapeutics' revenue[5].

Market Segmentation

The market for Silenor can be segmented in several ways:

Disease Type

Silenor is specifically indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. This focus on a specific type of sleep disorder helps in targeting a defined patient population[3].

Distribution Channels

Silenor is distributed through various channels including hospital pharmacies, retail pharmacies, and online pharmacies. This diverse distribution network ensures wide accessibility of the drug[1].

Competitive Landscape

The market for insomnia treatments is competitive, with several drugs and therapies available.

Key Players

Somaxon Pharmaceuticals, Inc., and its licensee Paladin Labs Inc., have been instrumental in the development and commercialization of Silenor. Pernix Therapeutics, which acquired the rights to Silenor, has also played a significant role in its marketing and sales[2][4].

Generic Competition

The potential introduction of generic versions of Silenor poses a significant threat to its market share. However, the patent protection and regulatory approvals have helped in maintaining its exclusivity to some extent[4].

Financial Highlights

Net Sales and Revenue

In the third quarter of 2014, Pernix Therapeutics reported a net sales increase of 72% compared to the same period in 2013, with Silenor contributing significantly to this growth. However, in subsequent years, the sales of Silenor have seen fluctuations, reflecting broader market and competitive dynamics[2].

Gross Margins and EBITDA

The inclusion of Silenor in Pernix Therapeutics' product portfolio has contributed to improved gross margins and adjusted EBITDA. For example, in the third quarter of 2014, the gross margin was 62.9%, and adjusted EBITDA was $6.9 million, reflecting the positive impact of Silenor on the company's financials[2].

Challenges and Opportunities

Regulatory and Patent Issues

Silenor's market trajectory is influenced by regulatory approvals and patent protections. The company must navigate these complexities to maintain its market position and prevent generic competition[4].

Market Expansion

The approval of Silenor in new regions, such as Canada, South America, and Africa, presents significant opportunities for market expansion. This geographic diversification can help in stabilizing and growing the drug's revenue[4].

Future Prospects

Increasing Demand for Insomnia Treatments

The growing prevalence of insomnia and the aging population are expected to drive the demand for drugs like Silenor. This trend is likely to continue, supporting the drug's market growth[1].

Research and Development

Continuous research and development activities in the field of sleep disorders can lead to new indications or formulations of Silenor, further enhancing its market potential[1].

Key Takeaways

• Market Drivers: Growing prevalence of insomnia, regulatory approvals, and clinical efficacy are key drivers for Silenor.
• Financial Performance: Silenor has shown significant revenue growth, although with fluctuations, and has contributed to improved gross margins and EBITDA for its parent companies.
• Market Segmentation: Silenor is targeted at specific sleep disorders and distributed through various channels.
• Competitive Landscape: The market is competitive, with potential generic competition posing a threat.
• Future Prospects: Increasing demand for insomnia treatments and potential new indications or formulations offer opportunities for growth.

FAQs

1. What is Silenor used for? Silenor is used for the treatment of insomnia characterized by difficulties with sleep maintenance, including frequent nocturnal awakenings and early morning awakenings[3].

2. Who are the key players involved in the commercialization of Silenor? Somaxon Pharmaceuticals, Inc., and its licensee Paladin Labs Inc., along with Pernix Therapeutics, have been instrumental in the development and commercialization of Silenor[2][4].

3. What are the main drivers of the demand for Silenor? The main drivers include the growing prevalence of insomnia, regulatory approvals, and the drug's clinical efficacy in maintaining sleep without significant next-day residual effects[1][4].

4. How has Silenor performed financially? Silenor has shown significant revenue growth, contributing to improved gross margins and EBITDA for its parent companies, although with some fluctuations over the years[2][5].

5. What are the potential challenges facing Silenor in the market? The potential introduction of generic versions, regulatory and patent issues, and competitive market dynamics are significant challenges facing Silenor[4].

Sources:

1. Data Bridge Market Research - Global Sedative-Hypnotic Drugs Market Size, Analysis & Overview By 2030
2. Business Wire - Pernix Therapeutics Reports Third Quarter 2014 Financial Results and Reaffirms Guidance
3. Minnesota Department of Human Services - Silenor
4. GlobeNewswire - Health Canada Approves Paladin Labs Inc. Silenor New Drug Submission
5. GlobeNewswire - Pernix Therapeutics Reports Second Quarter 2016 Financial Results and Business Update