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Last Updated: December 22, 2024

NORFLEX Drug Patent Profile


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

Norflex is a drug marketed by Pai Holdings Pharm and Bausch and is included in two NDAs.

The generic ingredient in NORFLEX is orphenadrine citrate. There are nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the orphenadrine citrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Norflex

A generic version of NORFLEX was approved as orphenadrine citrate by WATSON LABS on March 15th, 1982.

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Summary for NORFLEX
Drug patent expirations by year for NORFLEX
Recent Clinical Trials for NORFLEX

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

SponsorPhase
OSF Healthcare SystemPhase 4
University of Illinois College of Medicine at PeoriaPhase 4
Sagent Pharmaceuticals, Inc.Phase 4

See all NORFLEX clinical trials

US Patents and Regulatory Information for NORFLEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pai Holdings Pharm NORFLEX orphenadrine citrate INJECTABLE;INJECTION 013055-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch NORFLEX orphenadrine citrate TABLET, EXTENDED RELEASE;ORAL 012157-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NORFLEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Norflex (Orphenadrine)

Overview of Norflex

Norflex, known generically as orphenadrine, is a muscle relaxant used to alleviate pain, stiffness, and discomfort associated with acute musculoskeletal conditions. It was first approved by the FDA in 1952 and works by blocking nerve impulses in the central nervous system, as well as possessing anticholinergic properties[3][4][5].

Market Size and Growth

The muscle relaxant drugs market, which includes Norflex, has been experiencing significant growth. In 2023, the global market size for muscle relaxant drugs was $4.46 billion, and it is projected to grow to $4.83 billion in 2024 at a compound annual growth rate (CAGR) of 8.2%. By 2028, the market is expected to reach $6.55 billion, growing at a CAGR of 7.9%[1].

Segmentation and Market Share

The muscle relaxant market is segmented by drug type, formulation, route of administration, and end-user. Norflex falls under the category of skeletal muscle relaxant drugs. Here are some key segments relevant to Norflex:

  • By Drug Type: Skeletal muscle relaxant drugs, which include Norflex, are a significant segment within the muscle relaxant market.
  • By Formulation: Norflex is available in various formulations, including tablets, extended-release tablets, and injections.
  • By Route of Administration: Norflex can be administered orally or via injection.
  • By End-User: The primary end-users include hospitals, homecare, specialty clinics, and other healthcare settings[1].

Regional Market Performance

North America was the largest region in the muscle relaxant drugs market in 2023, indicating a strong demand for muscle relaxants like Norflex in this region. Other significant regions include Asia-Pacific, Western Europe, and Eastern Europe[1].

Financial Performance and Pricing

Cost and Pricing

The cost of Norflex can vary depending on the formulation and dosage. For example, 30 tablets of Norflex (100 mg) can average around $160, which translates to about $5.33 per day. This makes it potentially less expensive than some other muscle relaxants like Robaxin, especially at higher dosages[3].

Prescription Volume

In 2020, orphenadrine (Norflex) was prescribed to approximately 2 million individuals in the USA, accounting for nearly 4% of muscle relaxant prescriptions. This indicates a steady but not rapidly growing market share for Norflex within the muscle relaxant category[3].

Competitive Landscape

Norflex competes with other muscle relaxants such as Robaxin (methocarbamol) and Zanaflex (tizanidine). Here are some key differences and competitive aspects:

  • Mechanism of Action: Norflex works within the central nervous system and has anticholinergic properties, distinguishing it from other muscle relaxants like Robaxin and Zanaflex, which have different mechanisms of action[3][5].
  • Side Effects: Norflex tends to cause more anticholinergic side effects such as dry mouth compared to Robaxin, which could limit its use, especially among older adults[3].
  • Prescription Volume: While Robaxin is more widely prescribed, with around 5 million prescriptions in the US in 2020, Norflex maintains a significant presence in the market[3].

Recent Developments and Acquisitions

In June 2023, Corona Remedies, an India-based pharmaceutical company, acquired the muscle relaxant brand Myoril from Sanofi India. Although this acquisition does not directly involve Norflex, it highlights the active and competitive nature of the muscle relaxant market in regions like India, which could influence the broader market dynamics[1].

Future Trends and Outlook

The muscle relaxant market, including Norflex, is expected to see strong growth driven by several factors:

  • Multidisciplinary Pain Management: The increasing adoption of multidisciplinary approaches to pain management will drive the demand for muscle relaxants.
  • Aging Population and Chronic Conditions: The growing aging population and the rise in chronic conditions will contribute to the market's growth.
  • Advancements in Pain Management Therapies: Research in targeted therapies and advancements in pain management will further boost the market[1].

Key Takeaways

  • The muscle relaxant market, which includes Norflex, is growing strongly, driven by shifts in treatment approaches and an aging population.
  • Norflex is a significant player in the skeletal muscle relaxant segment, with a unique mechanism of action and side effect profile.
  • The drug's financial performance is influenced by its pricing, prescription volume, and competitive landscape.
  • Future growth will be driven by advancements in pain management and the increasing need for effective muscle relaxants.

FAQs

What is Norflex used for?

Norflex, or orphenadrine, is used to relieve pain, stiffness, and discomfort caused by acute musculoskeletal conditions such as strains and sprains. It also has applications in managing symptoms of Parkinson's disease[3][4][5].

How does Norflex work?

Norflex works by blocking nerve impulses in the central nervous system and possesses anticholinergic properties, which help in reducing muscle contractions and alleviating symptoms of muscle injuries[3][4][5].

What are the common side effects of Norflex?

Common side effects include dry mouth or throat, blurred vision, dizziness, and increased heart rate. It can also cause more severe side effects such as glaucoma, joint or muscle pain, and numbness or tingling of face, hands, or feet[2][4].

How much does Norflex cost?

The cost of Norflex can vary, but 30 tablets of Norflex (100 mg) can average around $160, which is about $5.33 per day[3].

Is Norflex available in generic form?

Yes, Norflex is available in generic form as orphenadrine citrate. Generic versions can offer significant savings compared to the brand name[2][3].

What are the contraindications for Norflex?

Norflex is contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (megaesophagus), and myasthenia gravis. It is also contraindicated in patients who have demonstrated a previous hypersensitivity to the drug[2][4].

Sources

  1. The Business Research Company: Muscle Relaxant Drugs Global Market Report 2024
  2. Drugs.com: Norflex: Package Insert / Prescribing Information
  3. Withpower.com: Robaxin vs Norflex | Power - Clinical Trials
  4. Mayo Clinic: Orphenadrine (oral route) - Mayo Clinic
  5. Withpower.com: Zanaflex vs Norflex | Power - Clinical Trials

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