OTREXUP Drug Patent Profile

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

Otrexup is a drug marketed by Otter Pharms and is included in one NDA. There are fourteen patents protecting this drug.

This drug has thirty-seven patent family members in fourteen countries.

The generic ingredient in OTREXUP is methotrexate. There are twenty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methotrexate profile page.

DrugPatentWatch^® Generic Entry Outlook for Otrexup

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 24, 2026. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for OTREXUP

International Patents:	37
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	7
Patent Applications:	4,352
Drug Prices:	Drug price information for OTREXUP
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OTREXUP
What excipients (inactive ingredients) are in OTREXUP?	OTREXUP excipients list
DailyMed Link:	OTREXUP at DailyMed

See drug prices for OTREXUP

See drug sales revenues for OTREXUP

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

Constraining patent/regulatory exclusivity:

9,629,959

NDA:

204824

Dosage:

SOLUTION;SUBCUTANEOUS

^*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 OTREXUP

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

Sponsor	Phase
Vanderbilt University	Phase 1
University of Virginia	Phase 1
University of Wisconsin, Madison	Phase 1

See all OTREXUP clinical trials

Pharmacology for OTREXUP

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

US Patents and Regulatory Information for OTREXUP

OTREXUP is protected by fourteen US patents.

This potential generic entry date is based on patent 9,629,959.

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
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013		RX	Yes	Yes	9,421,333		Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-004	Oct 11, 2013		RX	Yes	Yes	8,480,631		Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016		RX	Yes	Yes	8,021,335		Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016		RX	Yes	Yes	8,480,631		Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-008	Mar 24, 2016		RX	Yes	Yes	9,421,333		Y

Expired US Patents for OTREXUP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013	RE44846
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013	7,744,582
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013	6,746,429
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013	7,744,582
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-004	Oct 11, 2013	RE44846

EU/EMA Drug Approvals for OTREXUP

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Nordic Group B.V.	Nordimet	methotrexate	EMEA/H/C/003983 Nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate,moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.	Authorised	no	no	no	2016-08-18
Therakind (Europe) Limited	Jylamvo	methotrexate	EMEA/H/C/003756 In rheumatological and dermatological diseasesActive rheumatoid arthritis in adult patients.Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients.In oncologyMaintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.	Authorised	no	no	no	2017-03-29

International Patents for OTREXUP

When does loss-of-exclusivity occur for OTREXUP?

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

Brazil

Canada

China

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Portugal

South Korea

Spain

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 OTREXUP around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2011513035
South Korea	20120028294	HAZARDOUS AGENT INJECTION SYSTEM
Japan	4299466
China	1212867
Denmark	1850892

OTREXUP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Otrexup

Introduction

Otrexup, a drug-device combination single-dose once-weekly auto-injector containing methotrexate, has been a significant player in the pharmaceutical market, particularly in the treatment of rheumatoid arthritis and psoriasis. Here, we will delve into the market dynamics and financial trajectory of Otrexup, especially following its acquisition by Assertio Holdings, Inc.

Product Overview

Otrexup is indicated for the treatment of certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis (pJIA), as well as for the control of symptoms of severe, resistant, disabling psoriasis in adults. It utilizes the VIBEX auto-injector® device and has a patent life extending until May 2031[1][4].

Acquisition by Assertio Holdings, Inc.

In December 2021, Assertio Holdings, Inc. acquired Otrexup from Antares Pharma, Inc. in a partially seller-financed transaction valued at $44.0 million, including working capital investments. The payment terms included $18.0 million upfront, $16.0 million on May 31, 2022, and $10.0 million on December 15, 2022[1][4].

Financial Impact on Assertio Holdings, Inc.

The acquisition of Otrexup has been a strategic move for Assertio, aligning with their unique digital platform and growth objectives. Here are some key financial implications:

Revenue Contribution

Otrexup contributed significantly to Assertio's revenue. As of the trailing 12 months ended September 30, 2021, Otrexup generated $15.5 million in revenue. Following the acquisition, Assertio raised its full-year net product sales and non-GAAP adjusted EBITDA guidance, reflecting the positive impact of Otrexup on their financial performance[1][4].

Updated Financial Guidance

Assertio updated its 2021 financial guidance, increasing the full-year net product sales to greater than $108.0 million and non-GAAP adjusted EBITDA to greater than $48.0 million. This revision was largely due to the strong sales performance of their existing portfolio and the addition of Otrexup[1].

Performance in 2022

In 2022, Assertio reported a 42% increase in net product sales, driven in part by the full-quarter sales of Otrexup and the addition of another product, Sympazan. Adjusted EBITDA increased by 108%, and operating cash flow improved by $73.1 million. The fourth quarter of 2022 saw a 55% increase in net product sales to $49.9 million, with Otrexup contributing to this growth[2].

Market Dynamics

Competitive Landscape

Otrexup operates in a competitive market for rheumatoid arthritis and psoriasis treatments. However, its unique delivery mechanism via the VIBEX auto-injector® and its prescription-only status help it maintain a niche position. Antares Pharma, the original developer, had a dedicated sales force of 36 individuals marketing Otrexup to rheumatologists, which has likely been leveraged by Assertio post-acquisition[3].

Growth Potential

With nearly ten years of patent life remaining, Otrexup presents significant growth potential. Assertio plans to invest in further commercialization, leveraging their digital platform and expertise to drive growth. The company aims to achieve at least $50 million in gross profit from new product acquisitions by 2024, with Otrexup being a key component of this strategy[1][4].

Gross Margin

Otrexup boasts an approximate gross margin in the low 70% range, which is highly favorable. This high margin contributes to the overall profitability of the product and supports Assertio's financial goals[1][4].

Operational and Commercial Strategy

Sales and Marketing

Assertio has increased its sales and marketing expenses to promote Otrexup and other newly acquired products. This includes higher stock-based compensation and sales and marketing expenses, reflecting the company's commitment to driving growth through these products[2].

Integration with Existing Portfolio

The acquisition of Otrexup has been integrated into Assertio's existing portfolio, which includes products like Indocin and Sympazan. This integration has helped offset declines in other products and has contributed to the overall positive financial performance of the company[2].

Key Takeaways

• Acquisition Impact: The acquisition of Otrexup by Assertio Holdings, Inc. has been financially beneficial, contributing to increased revenue and adjusted EBITDA.
• Revenue Contribution: Otrexup generated $15.5 million in revenue in the trailing 12 months ended September 30, 2021, and continues to contribute significantly to Assertio's financial performance.
• Growth Potential: With a remaining patent life of nearly ten years, Otrexup offers substantial growth potential, especially when leveraged through Assertio's digital platform and commercial expertise.
• Financial Guidance: The acquisition led to an update in Assertio's financial guidance, reflecting increased net product sales and adjusted EBITDA.

FAQs

What is Otrexup used for?

Otrexup is used for the treatment of certain adults with severe, active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis (pJIA), and for controlling symptoms of severe, resistant, disabling psoriasis in adults[1][4].

Who acquired Otrexup and when?

Assertio Holdings, Inc. acquired Otrexup from Antares Pharma, Inc. in December 2021[1][4].

What was the purchase price for Otrexup?

The total purchase price for Otrexup was $44.0 million, including working capital investments, with payment terms spread over several installments[1][4].

How has Otrexup impacted Assertio's financial performance?

Otrexup has contributed to increased net product sales and adjusted EBITDA for Assertio, helping the company raise its financial guidance and achieve significant growth in 2022[1][2].

What is the gross margin for Otrexup?

The gross margin for Otrexup is approximately in the low 70% range[1][4].

Sources

1. GlobeNewswire: Assertio Holdings, Inc. Announces the Acquisition of Otrexup (methotrexate) a Drug Device Combination from Antares Pharma, Inc.
2. Assertio Reports Fourth Quarter and Full Year 2022 Financial Results
3. Small-Cap Research: Antares Pharma, Inc.
4. BioSpace: Assertio Holdings, Inc. Announces the Acquisition of Otrexup (methotrexate) a Drug Device Combination from Antares Pharma, Inc.