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Last Updated: February 7, 2025

OTREXUP Drug Patent Profile


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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 three 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

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Drug patent expirations by year for OTREXUP
Drug Prices for OTREXUP

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Drug Sales Revenue Trends for OTREXUP

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OTREXUP
Generic Entry Date for OTREXUP*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Virginia Commonwealth UniversityPhase 1
PfizerPhase 1
Vanderbilt UniversityPhase 1

See all OTREXUP clinical trials

Pharmacology for OTREXUP

US Patents and Regulatory Information for OTREXUP

OTREXUP is protected by fourteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OTREXUP is ⤷  Try for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

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 ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Otter Pharms OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824-010 May 31, 2017 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for OTREXUP

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 ⤷  Try for Free ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016 ⤷  Try for Free ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-003 Oct 11, 2013 ⤷  Try for Free ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-005 Nov 7, 2014 ⤷  Try for Free ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 ⤷  Try for Free ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 ⤷  Try for Free ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for OTREXUP

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

Country Patent Number Title Estimated Expiration
South Korea 20070117543 PREFILLED NEEDLE ASSISTED JET INJECTOR ⤷  Try for Free
Japan 5216328 ⤷  Try for Free
Austria 240756 ⤷  Try for Free
Canada 2755779 SYSTEME D'INJECTION D'AGENTS DANGEREUX (HAZARDOUS AGENT INJECTION SYSTEM) ⤷  Try for Free
Japan 2008528126 ⤷  Try for Free
China 1323230 ⤷  Try for Free
Japan 4299466 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

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.

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