REDITREX Drug Patent Profile

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

Reditrex is a drug marketed by Nordic Grp and is included in one NDA.

The generic ingredient in REDITREX 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 REDITREX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	137
Patent Applications:	4,385
Drug Prices:	Drug price information for REDITREX
What excipients (inactive ingredients) are in REDITREX?	REDITREX excipients list
DailyMed Link:	REDITREX at DailyMed

See drug prices for REDITREX

US Patents and Regulatory Information for REDITREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nordic Grp	REDITREX	methotrexate	SOLUTION;SUBCUTANEOUS	210737-001	Nov 27, 2019		DISCN	Yes	No
Nordic Grp	REDITREX	methotrexate	SOLUTION;SUBCUTANEOUS	210737-007	Nov 27, 2019		DISCN	Yes	No
Nordic Grp	REDITREX	methotrexate	SOLUTION;SUBCUTANEOUS	210737-004	Nov 27, 2019		DISCN	Yes	No
Nordic Grp	REDITREX	methotrexate	SOLUTION;SUBCUTANEOUS	210737-008	Nov 27, 2019		DISCN	Yes	No

EU/EMA Drug Approvals for REDITREX

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

REDITREX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RediTrex

Introduction

RediTrex, a prefilled syringe formulation of methotrexate, is a significant product in the pharmaceutical landscape, particularly for treating severe, active rheumatoid arthritis and active polyarticular juvenile idiopathic arthritis. Here, we delve into the market dynamics and financial trajectory of RediTrex, highlighting key aspects that influence its position in the market.

Market Demand for Methotrexate

Methotrexate, the active ingredient in RediTrex, is a widely used drug for various inflammatory diseases, including rheumatoid arthritis, juvenile rheumatoid arthritis, and lupus. The demand for methotrexate is driven by its status as the recommended first-line treatment for rheumatoid arthritis, with about 60% of patients with rheumatoid arthritis currently taking this medication[4].

Launch and Impact of RediTrex

Cumberland Pharmaceuticals Inc. launched RediTrex in November 2020, introducing a new prefilled syringe designed for ease of use and precise dosing for subcutaneous administration. This launch was a strategic move to enhance patient compliance and convenience, particularly for those with rheumatoid arthritis and psoriasis[4].

Financial Performance of Cumberland Pharmaceuticals

To understand the financial trajectory of RediTrex, it is essential to look at the financial performance of Cumberland Pharmaceuticals, the company behind the drug.

Revenue Growth

Cumberland Pharmaceuticals has reported significant revenue growth in recent years. For instance, in 2022, the company reported a 41% revenue growth, with net revenues from continuing operations reaching $11.4 million for the three months ended September 30, 2022[5].

Cash Flow and Net Income

The company's cash flow from operating activities has been a critical indicator of its financial health. In 2022, year-to-date cash flow from operations was $2.2 million, reflecting a positive trend. However, net income has been more volatile, with a net loss of $2.767 million in 2022, though this includes adjustments and discontinued operations[2].

Total Assets and Cash Equivalents

Cumberland Pharmaceuticals' financial position is strengthened by its total assets, which stood at $93 million in 2022. The company also maintained a significant amount of cash and cash equivalents, totaling $26.6 million at the end of the period[2].

Market Segmentation and Growth Drivers

Disease Type

The methotrexate market, including RediTrex, is segmented by disease type, with significant demand coming from autoimmune diseases and cancer. The cancer segment is expected to grow at a CAGR of 3.2% during the forecast period, driven by the rising incidence of various types of cancers globally[4].

End-User Segmentation

The hospital segment is expected to garner a significant share of the methotrexate market by 2037, due to the increasing influx of patients with target diseases. Specialty clinics are also expected to grow at a significant rate, contributing to the overall market growth[4].

Regional Market Dynamics

North America

The North American methotrexate market, where RediTrex is prominently positioned, is projected to hold a significant market share of 41% by the end of 2037. This growth is driven by high adoption of innovative technologies, higher healthcare expenditures, and the immediate availability of methotrexate pharmacotherapy[4].

Asia-Pacific

The Asia-Pacific region is also expected to see notable growth in the methotrexate market, driven by increasing awareness of different medical modalities and a surging number of female populations requiring medical abortion[4].

Challenges and Opportunities

Regulatory Hurdles

The pharmaceutical R&D landscape, including the development of drugs like RediTrex, faces significant challenges such as stricter regulatory hurdles and short exclusivity periods. These factors have contributed to a decline in the return on investment (ROI) for pharmaceutical R&D in recent years[3].

Market Potential

Despite these challenges, the potential rewards for successful drug development are substantial. Blockbuster drugs, such as AbbVie's Humira, have generated large revenue streams, and the pharmaceutical market is projected to exceed $1.4 trillion by 2028, driven by the escalating global burden of chronic diseases[3].

Competitive Landscape

RediTrex operates in a competitive market where other methotrexate formulations and treatments for autoimmune diseases and cancer are available. However, its ease of use and precise dosing features position it favorably among patients and healthcare providers[4].

Future Outlook

The future outlook for RediTrex is promising, given the growing demand for methotrexate and the strategic positioning of Cumberland Pharmaceuticals. The company's focus on innovation and patient convenience is likely to drive continued growth in the market.

Key Takeaways

• Market Demand: High demand driven by methotrexate's status as a first-line treatment for rheumatoid arthritis.
• Financial Performance: Cumberland Pharmaceuticals has reported significant revenue growth and positive cash flow from operations.
• Market Segmentation: Growth driven by autoimmune diseases and cancer segments.
• Regional Dynamics: North America and Asia-Pacific regions are key markets.
• Challenges and Opportunities: Regulatory hurdles and declining ROI in R&D, but substantial potential rewards.
• Competitive Landscape: Favorable positioning due to ease of use and precise dosing.

FAQs

What is RediTrex used for?

RediTrex is used to treat adults with severe, active rheumatoid arthritis and children with active polyarticular juvenile idiopathic arthritis.

Who launched RediTrex?

RediTrex was launched by Cumberland Pharmaceuticals Inc. in November 2020.

What is the projected market size for methotrexate drugs by 2037?

The methotrexate drugs market is set to exceed USD 846.99 million by 2037, registering a CAGR of over 2.9% during the forecast period[4].

What are the key growth drivers for the methotrexate market?

Key growth drivers include the increasing use of methotrexate for inflammatory diseases, rising incidence of cancers, and growing demand in regions like North America and Asia-Pacific[4].

How does RediTrex differentiate itself in the market?

RediTrex differentiates itself through its prefilled syringe formulation designed for ease of use and precise dosing for subcutaneous administration[4].

Sources:

1. Cumberland Pharmaceuticals Reports Third Quarter 2021 Financial Results - Cumberland Pharmaceuticals Inc.
2. Cumberland Pharmaceuticals Reports 14% Revenue Growth - PR Newswire
3. Investment Trends in Pharmaceutical Research and Development - DrugBank Blog
4. Methotrexate Drugs Market Size & Share, Forecast Report 2037 - Research Nester
5. Cumberland Pharmaceuticals Reports 41% Revenue Growth - Cumberland Pharmaceuticals Inc.