OTREXUP PFS Drug Patent Profile

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

Otrexup Pfs is a drug marketed by Otter Pharms and is included in one NDA.

The generic ingredient in OTREXUP PFS 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.

Summary for OTREXUP PFS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	7
Patent Applications:	4,352
DailyMed Link:	OTREXUP PFS at DailyMed

Recent Clinical Trials for OTREXUP PFS

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

Sponsor	Phase
University of Wisconsin, Madison	Phase 1
Virginia Commonwealth University	Phase 1
Pfizer	Phase 1

See all OTREXUP PFS clinical trials

Pharmacology for OTREXUP PFS

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

US Patents and Regulatory Information for OTREXUP PFS

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 PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-009	May 31, 2017		DISCN	Yes	No
Otter Pharms	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-012	May 31, 2017		DISCN	Yes	No
Otter Pharms	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-010	May 31, 2017		DISCN	Yes	No
Otter Pharms	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-011	May 31, 2017		DISCN	Yes	No
Otter Pharms	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-014	May 31, 2017		DISCN	Yes	No

EU/EMA Drug Approvals for OTREXUP PFS

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 PFS

See the table below for patents covering OTREXUP PFS 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 PFS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Otrexup PFS

Introduction to Otrexup PFS

Otrexup is a prescription medicine containing methotrexate, administered via a single-dose, once-weekly auto-injector. It is indicated for the treatment of adults with rheumatoid arthritis (RA), pediatric patients with polyarticular juvenile rheumatoid arthritis (p-JRA), and adults with severe psoriasis[4].

Market Overview

The global methotrexate market, which includes Otrexup, is expected to grow significantly due to increasing applications in treating cancer and arthritis. Here are some key market dynamics:

Regional Outlook

• North America dominates the global methotrexate market due to the high prevalence of cancer, psoriasis, and arthritis, along with the presence of key players.
• Europe holds the second largest market share, driven by a large patient base and advanced healthcare infrastructure.
• The Asia Pacific region is expected to grow at the fastest pace, driven by a large patient pool, advancing research, and growing healthcare infrastructure[1].

End-User Segment

• Hospitals are expected to be the leading end-users due to their advanced facilities and high treatment costs[1].

Formulation Segment

• Injectable formulations, such as Otrexup, are anticipated to lead the market segment due to their higher efficacy compared to oral methotrexate[1].

Acquisition and Financial Impact

In December 2021, Assertio Holdings, Inc. acquired Otrexup from Antares Pharma, Inc. in a partially seller-financed transaction.

Acquisition Details

• The total purchase price was $44.0 million, including working capital investments.
• Payment terms included $18.0 million upfront, $16.0 million by May 31, 2022, and $10.0 million by December 15, 2022[2][3].

Financial Guidance

• The acquisition led Assertio to raise its full-year net product sales and non-GAAP adjusted EBITDA guidance. The updated guidance includes net product sales greater than $108.0 million and adjusted EBITDA greater than $48.0 million for 2021[2][3].

Revenue and Gross Margin

• The trailing 12-month reported revenues for Otrexup were $15.5 million as of September 30, 2021.
• The product has an approximate gross margin percentage in the low 70s[3].

Commercialization and Growth Potential

Assertio plans to invest in the further commercialization of Otrexup, leveraging its unique digital platform and expertise. The acquisition is seen as a strategic fit and a growth driver for Assertio, with nearly ten years of patent life remaining for Otrexup[2][3].

Market Acceptance and Patient Preference

• Otrexup offers a convenient and practical solution for patients to self-inject methotrexate, which is particularly beneficial for patients with diminished manual dexterity, such as those with RA.
• Studies have shown that patients prefer injecting a low-volume product, which aligns with Otrexup's delivery mechanism[4].

Regulatory and Clinical Context

• Otrexup was approved as a 505(b)(2) new drug application (NDA) and does not require a Risk Evaluation and Mitigation Strategy (REMS) to ensure its benefits outweigh its risks[4].

Bioavailability and Efficacy

• The subcutaneous administration of Otrexup is bioequivalent to intramuscular administration and offers better bioavailability compared to oral methotrexate, potentially improving disease symptoms and reducing gastrointestinal toxicity[4].

Competitive Landscape

• The acquisition of Otrexup by Assertio positions the company to compete more effectively in the methotrexate market, particularly with its unique auto-injector delivery system.
• Key players in the methotrexate market continue to innovate and expand their product portfolios, driving market growth and competition[1][2].

Future Outlook and Challenges

• Assertio aims to achieve at least $50 million in gross profit by 2024 through the acquisition and commercialization of new products, including Otrexup.
• However, the company faces challenges such as risks related to commercialization, potential liabilities, and the integration of new products into their existing portfolio[2][3].

Key Takeaways

• Otrexup PFS is a significant player in the growing methotrexate market, driven by its efficacy and convenience.
• The acquisition by Assertio Holdings, Inc. is expected to drive growth and increase market presence.
• The product's unique delivery system and remaining patent life offer substantial commercialization potential.
• Assertio's financial guidance has been positively impacted by the acquisition, reflecting the product's revenue and gross margin performance.

FAQs

What is Otrexup PFS used for?

Otrexup PFS is used for the treatment of adults with rheumatoid arthritis (RA), pediatric patients with polyarticular juvenile rheumatoid arthritis (p-JRA), and adults with severe psoriasis[4].

Who acquired Otrexup PFS and why?

Assertio Holdings, Inc. acquired Otrexup PFS from Antares Pharma, Inc. in December 2021. The acquisition was seen as a strategic and synergistic fit with Assertio's digital platform and a growth driver for the company[2][3].

What is the financial impact of the acquisition on Assertio Holdings, Inc.?

The acquisition led Assertio to raise its full-year net product sales and non-GAAP adjusted EBITDA guidance. The updated guidance includes net product sales greater than $108.0 million and adjusted EBITDA greater than $48.0 million for 2021[2][3].

What are the key benefits of Otrexup PFS over other methotrexate formulations?

Otrexup PFS offers better bioavailability compared to oral methotrexate, reduced gastrointestinal toxicity, and a convenient auto-injector delivery system that is preferred by patients[4].

How long does the patent for Otrexup PFS remain in effect?

The patent for Otrexup PFS remains in effect until May 2031, providing nearly ten years of exclusive commercialization rights[3].

Cited Sources:

1. Biospace - Methotrexate Market is expected to grow further with its Increasing application in the treatment of cancer and arthritis[1].
2. GlobeNewswire - Assertio Holdings, Inc. Announces the Acquisition of Otrexup (methotrexate) from Antares Pharma, Inc.[2].
3. Biospace - Assertio Holdings, Inc. Announces the Acquisition of Otrexup (methotrexate) from Antares Pharma, Inc.[3].
4. FDA - 204824Orig2s000 RiskR - Otrexup (methotrexate) injectable in a PFS[4].