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horizant Drug Patent Profile

When do Horizant patents expire, and what generic alternatives are available?

Horizant is a drug marketed by Azurity and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-six patent family members in twenty-six countries.

The generic ingredient in HORIZANT is gabapentin enacarbil. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gabapentin enacarbil profile page.

DrugPatentWatch^® Generic Entry Outlook for Horizant

Horizant was eligible for patent challenges on April 6, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 10, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2021 were $171mm indicating the motivation for generic entry (peak sales were $535mm in 2018).

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for horizant

International Patents:	146
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	15
Patent Applications:	222
Drug Prices:	Drug price information for horizant
Drug Sales Revenues:	Drug sales revenues for horizant
What excipients (inactive ingredients) are in horizant?	horizant excipients list
DailyMed Link:	horizant at DailyMed

See drug prices for horizant

See drug sales revenues for horizant

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for horizant

Constraining patent/regulatory exclusivity:

8,795,725

NDA:

022399

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for horizant

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

Sponsor	Phase
Azurity Pharmaceuticals	Phase 4
Massachusetts General Hospital	Phase 4
University of California, Davis	Phase 3

See all horizant clinical trials

Pharmacology for horizant

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for HORIZANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HORIZANT	Extended-release Tablets	gabapentin enacarbil	300 mg and 600 mg	022399	1	2019-04-29

US Patents and Regulatory Information for horizant

horizant is protected by seven US patents.

This potential generic entry date is based on patent 8,795,725.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No	8,114,909
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No	8,026,279		Y	Y
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No	8,795,725		Y
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes	8,795,725		Y

Expired US Patents for horizant

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011	8,048,917
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011	8,048,917

International Patents for horizant

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

Country	Patent Number	Title	Estimated Expiration
Japan	4310271
China	1675165	Methods for synthesis of acyloxyalkyl derivatives of GABA analogs
South Korea	101157436
Canada	2538802	TRAITEMENT OU PREVENTION DU SYNDROME DES JAMBES SANS REPOS AL'AIDE DE PROMEDICAMENTS A BASE D'ANALOGUES DU GABA (TREATING OR PREVENTING RESTLESS LEGS SYNDROME USING PRODRUGSOF GABA ANALOGS)

Horizant Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Horizant (Gabapentin Enacarbil)

Introduction

Horizant, also known as gabapentin enacarbil, is a medication primarily used for the treatment of restless legs syndrome (RLS) and has been explored for other indications such as alcohol use disorder. This article delves into the market dynamics and financial trajectory of Horizant, highlighting its commercial performance, clinical trials, and significant events that have shaped its market presence.

Commercial Performance of Horizant

Initial Launch and Growth

Following its approval in 2011, Horizant saw a slow start in sales. However, by the fourth quarter of 2013, the drug showed significant growth. Net sales of Horizant Extended-Release Tablets in the United States increased by 34% compared to the third quarter of 2013, marking a substantial improvement in its commercial performance[1].

Sales and Prescription Trends

The number of prescribed pills for Horizant increased by 27% nationwide in the fourth quarter of 2013 compared to the third quarter. In territories where XenoPort actively promoted the drug, the increase was even more pronounced, with a 39% rise in prescribed pills[1].

Financial Projections and Actuals

Despite initial slow sales, XenoPort forecasted sales of $60 million to $65 million for Horizant in the year following its improved marketing efforts. This optimism was shared by Arbor Pharma, which later acquired XenoPort for $467 million, highlighting the potential they saw in the drug's market performance[4].

Clinical Trials and Efficacy

Restless Legs Syndrome (RLS)

Horizant has been extensively studied and approved for the treatment of moderate-to-severe primary RLS in adults. Clinical trials, including a Phase 4 study conducted by GlaxoSmithKline (GSK), have supported its efficacy and safety profile. Common adverse reactions include somnolence/sedation, dizziness, headache, nausea, and fatigue[1].

Alcohol Use Disorder (AUD)

In addition to RLS, Horizant was investigated for the treatment of alcohol use disorder. A Phase 2 clinical trial conducted by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) evaluated the efficacy and safety of gabapentin enacarbil for AUD. However, the trial did not show significant differences between the Horizant and placebo groups on primary or secondary outcome measures[3].

Market Dynamics and Challenges

Competition and Market Position

The market for RLS treatments is competitive, but Horizant has managed to carve out a niche for itself. Despite initial challenges, including the withdrawal of GSK as a co-marketing partner, XenoPort's targeted educational efforts and marketing strategies helped in increasing the drug's visibility and adoption among physicians[1].

Regulatory Environment

The approval and post-marketing commitments imposed by the FDA have played a crucial role in shaping Horizant's market trajectory. The Phase 4 clinical trial, for instance, was part of these commitments and helped in further establishing the drug's safety and efficacy profile[1].

Acquisition and Change in Ownership

Arbor Pharma Acquisition

In 2016, Arbor Pharma acquired XenoPort for $467 million, with Horizant being the key asset driving this acquisition. Arbor expressed confidence in the XenoPort sales team's ability to grow Horizant sales further, indicating a positive outlook on the drug's market potential[4].

Financial Trajectory

Revenue Growth

The financial performance of Horizant has been marked by periods of growth and stabilization. From generating $41.2 million in sales in the year prior to the acquisition to projected sales of $60 million to $65 million, Horizant has shown a steady increase in revenue[4].

Impact of Marketing Efforts

The increased focus on marketing and educational efforts by XenoPort significantly contributed to the drug's revenue growth. These efforts were recognized by Arbor Pharma, which continued to support and expand these initiatives post-acquisition[1][4].

Industry Expert Insights

"The XenoPort sales team has done an excellent job of growing Horizant, and we look forward to supporting them to continue this significant momentum," said Ed Schutter, CEO of Arbor Pharma, reflecting the industry's positive outlook on Horizant's market performance[4].

Key Statistics

• 34% Increase in Sales: Net sales of Horizant increased by 34% in the fourth quarter of 2013 compared to the third quarter[1].
• $467 Million Acquisition: Arbor Pharma acquired XenoPort for $467 million, highlighting the value placed on Horizant[4].
• $60-$65 Million Projected Sales: Forecasted annual sales for Horizant following improved marketing efforts[4].

Conclusion

Horizant's market dynamics and financial trajectory have been shaped by its clinical efficacy, marketing efforts, and changes in ownership. Despite initial challenges, the drug has demonstrated significant growth potential, particularly in the treatment of restless legs syndrome. The acquisition by Arbor Pharma further underscores the confidence in Horizant's market performance.

Key Takeaways

• Horizant has shown significant growth in sales and prescriptions, particularly in the fourth quarter of 2013.
• The drug has been approved for the treatment of moderate-to-severe primary RLS and has been investigated for AUD.
• Marketing and educational efforts have been crucial in increasing the drug's adoption.
• The acquisition by Arbor Pharma highlights the drug's market potential.
• Common adverse reactions include somnolence/sedation, dizziness, headache, nausea, and fatigue.

FAQs

What is Horizant primarily used for?

Horizant is primarily used for the treatment of moderate-to-severe primary restless legs syndrome (RLS) in adults.

How did the sales of Horizant perform in the fourth quarter of 2013?

The sales of Horizant increased by 34% in the fourth quarter of 2013 compared to the third quarter, with a 27% increase in prescribed pills nationwide and a 39% increase in promoted territories.

Who acquired XenoPort, the manufacturer of Horizant?

Arbor Pharma acquired XenoPort for $467 million in 2016.

What other condition was Horizant investigated for?

Horizant was investigated for the treatment of alcohol use disorder (AUD) in a Phase 2 clinical trial.

What are the common adverse reactions associated with Horizant?

Common adverse reactions include somnolence/sedation, dizziness, headache, nausea, and fatigue.

Sources

1. Sleep Review: "Q4 Horizant Sales Up 34% Compared to Q3"
2. Heron Therapeutics: "Heron Therapeutics Announces Third Quarter 2024 Financial Results"
3. National Institute on Alcohol Abuse and Alcoholism: "Horizant Study Data Access"
4. BioPharma Dive: "Arbor Pharma buys XenoPort for $467 million"