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Last Updated: March 16, 2025

NORTHERA Drug Patent Profile


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

Northera is a drug marketed by Lundbeck Na Ltd and is included in one NDA.

The generic ingredient in NORTHERA is droxidopa. There are six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the droxidopa profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Northera

A generic version of NORTHERA was approved as droxidopa by AJANTA PHARMA LTD on February 18th, 2021.

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Summary for NORTHERA
Drug patent expirations by year for NORTHERA
Drug Prices for NORTHERA

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Recent Clinical Trials for NORTHERA

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SponsorPhase
Loma Linda UniversityPhase 2
H. Lundbeck A/SPhase 2
Stephen G. Kaler, MDPhase 1/Phase 2

See all NORTHERA clinical trials

Pharmacology for NORTHERA
Physiological EffectIncreased Blood Pressure

US Patents and Regulatory Information for NORTHERA

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Lundbeck Na Ltd NORTHERA droxidopa CAPSULE;ORAL 203202-001 Feb 18, 2014 AB RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Lundbeck Na Ltd NORTHERA droxidopa CAPSULE;ORAL 203202-002 Feb 18, 2014 AB RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Lundbeck Na Ltd NORTHERA droxidopa CAPSULE;ORAL 203202-003 Feb 18, 2014 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  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
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Northera (Droxidopa)

Market Overview

Northera, also known as droxidopa, is a crucial medication in the treatment of orthostatic hypotension (OH), a condition characterized by a significant drop in blood pressure when standing up from a sitting or lying position. Here’s a detailed look at the market dynamics and financial trajectory of Northera.

Market Segmentation and Growth

Product Segment

Northera (droxidopa) is a norepinephrine prodrug that helps alleviate symptoms of OH by enhancing blood flow. It is part of the orthostatic hypotension drugs market, which is segmented into midodrine, Northera (droxidopa), fludrocortisone, and other drugs. The Northera segment is expected to grow faster and emerge as a market leader by the end of the forecast period due to its efficacy in managing OH symptoms[1][3][4].

Geographic Landscape

Regional Market Share

The orthostatic hypotension drugs market, including Northera, is geographically segmented into North America, Europe, Asia, and the Rest of the World (RoW). North America, particularly the United States and Canada, is projected to account for a significant share of the global market. This is due to the region's well-established healthcare infrastructure and high per capita pharmaceutical expenditure[4].

Competitive Landscape

Key Players

The market for orthostatic hypotension drugs, including Northera, is moderately fragmented with several major players. Key companies involved include Amneal Pharmaceuticals Inc., H. Lundbeck AS, Mylan N.V., Novartis AG, and Pfizer Inc. Lundbeck, in particular, has been a significant player in the development and marketing of Northera[1][3].

Financial Performance and Projections

Revenue Growth

The revenue from Northera is expected to contribute significantly to the overall growth of the orthostatic hypotension drugs market. The market is projected to grow at a CAGR of 9.06% from 2022 to 2026, with an estimated market growth of USD 571.76 million during this period. Northera's growth is driven by its clinical efficacy and the increasing demand for effective OH treatments[4].

Clinical Trials and R&D

Lundbeck has been actively involved in clinical trials to assess the sustained effects of droxidopa therapy. For instance, a Phase 5 clinical trial (post-marketing study) in the US was completed in December 2020 to evaluate the long-term efficacy of Northera. Such initiatives are expected to boost market growth and reinforce Northera's position in the market[4].

Market Drivers and Challenges

Drivers

  • Increasing Elderly Population: The growing elderly population, which is more susceptible to OH, is a significant driver for the market.
  • Advances in Pharmaceutical Research: Continuous innovation and the development of more targeted therapies are enhancing treatment efficacy and patient compliance.
  • High Unmet Need: There is a high unmet need for drugs with substantial clinical efficiency and a high safety profile, driving R&D efforts[3][4].

Challenges

  • Regulatory Approvals: One of the key challenges is the lack of approval for new drugs with substantial clinical efficiency and a high safety profile.
  • Competition: The market is moderately fragmented, and competition from other drugs like midodrine and fludrocortisone can impact Northera's market share[1][4].

Customer Landscape

Application Segments

Northera is used in various healthcare settings, including hospitals, medical research institutes, clinics, and other healthcare facilities. In hospitals, it helps manage symptoms in patients undergoing surgical procedures or those with chronic conditions. Medical research institutes use it for clinical trials, while clinics focus on outpatient care, providing personalized treatment plans[3].

Financial Impact on Key Players

Lundbeck’s Financial Performance

Lundbeck, a key player in the Northera market, has seen significant revenue growth from its strategic brands. While the company's overall financial performance includes a mix of various products, the growth in Northera sales contributes to its revenue. For example, Lundbeck's Q1 2024 report showed an increase in revenue, partly due to targeted investments in sales and promotion, which would include efforts for Northera[2].

Key Takeaways

  • Market Growth: Northera is expected to emerge as a market leader in the orthostatic hypotension drugs market due to its efficacy.
  • Geographic Focus: North America, particularly the US and Canada, will be significant contributors to the market growth.
  • R&D and Clinical Trials: Ongoing clinical trials and R&D efforts are crucial for maintaining and enhancing Northera's market position.
  • Competitive Landscape: The market is moderately fragmented, with Lundbeck being a key player.
  • Financial Projections: The market is projected to grow at a CAGR of 9.06% from 2022 to 2026.

FAQs

What is Northera used for?

Northera (droxidopa) is used to treat orthostatic hypotension (OH), a condition characterized by a significant drop in blood pressure when standing up from a sitting or lying position.

Which region is expected to dominate the Northera market?

North America, particularly the United States and Canada, is expected to account for a significant share of the global Northera market due to its well-established healthcare infrastructure and high per capita pharmaceutical expenditure.

Who are the key players in the Northera market?

Key players include Amneal Pharmaceuticals Inc., H. Lundbeck AS, Mylan N.V., Novartis AG, and Pfizer Inc.

What is the projected CAGR for the orthostatic hypotension drugs market?

The market is projected to grow at a CAGR of 9.06% from 2022 to 2026.

What are the main drivers for the Northera market growth?

The main drivers include the increasing elderly population, advances in pharmaceutical research, and the high unmet need for effective OH treatments.

What challenges does the Northera market face?

The market faces challenges such as regulatory approvals for new drugs and competition from other OH treatments like midodrine and fludrocortisone.

Sources

  1. Global Orthostatic Hypotension Drugs Markets to 2023 - Globenewswire
  2. Lundbeck grows strategic brands by +17% CER - Lundbeck
  3. Orthostatic Hypotension Drugs Market Share & Market Analysis - OpenPR
  4. Orthostatic Hypotension Drugs Market Size, Share, Growth, Trends - Technavio

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