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Last Updated: December 22, 2024

REGITINE Drug Patent Profile


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

Regitine is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in REGITINE is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Regitine

A generic version of REGITINE was approved as phentolamine mesylate by HIKMA on March 11th, 1998.

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

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

SponsorPhase
National Institutes of Health (NIH)Early Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Early Phase 1
University of PennsylvaniaEarly Phase 1

See all REGITINE clinical trials

US Patents and Regulatory Information for REGITINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis REGITINE phentolamine mesylate INJECTABLE;INJECTION 008278-003 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

REGITINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Regitine (Phentolamine Mesylate)

Introduction

Regitine, known generically as phentolamine mesylate, is a medication with a long history of use in various medical applications. Here, we will delve into the market dynamics and financial trajectory of this drug, particularly focusing on its current status, usage, and financial implications.

Historical Context and Current Status

Regitine was originally developed and marketed for several indications, including the prevention or control of hypertensive episodes in patients with pheochromocytoma, prevention or treatment of dermal necrosis following norepinephrine administration, and as a diagnostic tool for pheochromocytoma[4].

However, the Regitine brand name has been discontinued in the U.S., and while generic versions may still be available, the market for this specific brand has diminished significantly.

Market Applications and Indications

Regitine is classified as a miscellaneous cardiovascular agent and is used for specific medical conditions:

  • Hypertensive Episodes: It is used to prevent or control hypertensive episodes in patients with pheochromocytoma, especially during preoperative preparation and surgical excision.
  • Dermal Necrosis: It prevents or treats dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine.
  • Diagnostic Tool: It is used in the Regitine blocking test for the diagnosis of pheochromocytoma[4].

Market Dynamics

The market for Regitine is limited due to several factors:

  • Discontinued Brand: The discontinuation of the Regitine brand name in the U.S. has reduced its market presence.
  • Generic Competition: The availability of generic versions of phentolamine mesylate can lead to price competition, further reducing the financial attractiveness of the branded product.
  • Narrow Indications: Regitine is used for very specific and relatively rare conditions, which limits its market size and growth potential.

Financial Trajectory

Given the discontinued status of the Regitine brand and the availability of generic alternatives, the financial trajectory for this drug is not promising:

  • Revenue Decline: The revenue generated from Regitine is expected to decline as generic versions capture more of the market share.
  • Limited Investment: Pharmaceutical companies are less likely to invest in marketing and research for a discontinued brand, further reducing its financial viability.
  • Alternative Treatments: The development and marketing of newer, more effective treatments for the same indications can also erode the market share of Regitine.

Comparison with Related Products

To understand the financial trajectory better, it's useful to compare Regitine with other products in the same therapeutic area or those developed by the same company.

  • Nyxol: For example, Ocuphire Pharma's Nyxol, which is also based on phentolamine mesylate but formulated as an eye drop, has shown significant market potential due to its broader indications (including refractive indications like presbyopia and dim light or night vision disturbances). Nyxol's market trajectory is more promising due to its wider application and partnership with Viatris for commercialization[1].

Key Takeaways

  • Discontinued Brand: Regitine's brand name has been discontinued in the U.S.
  • Generic Competition: Generic versions of phentolamine mesylate are available, reducing the market share of the branded product.
  • Narrow Indications: Regitine is used for very specific and relatively rare medical conditions.
  • Declining Revenue: The revenue from Regitine is expected to decline due to generic competition and limited market size.

FAQs

  1. What is Regitine used for? Regitine (phentolamine mesylate) is used to prevent or control hypertensive episodes in patients with pheochromocytoma, prevent or treat dermal necrosis following norepinephrine administration, and as a diagnostic tool for pheochromocytoma[4].

  2. Why has the Regitine brand been discontinued? The Regitine brand name has been discontinued in the U.S., likely due to market dynamics and the availability of generic alternatives.

  3. What are the financial implications of the discontinued brand? The discontinuation of the Regitine brand is expected to lead to a decline in revenue as generic versions capture more of the market share.

  4. How does Regitine compare to other products in the same therapeutic area? Regitine's market potential is limited compared to other products like Nyxol, which has broader indications and a more promising market trajectory due to its partnership with Viatris[1].

  5. What are the future prospects for Regitine? The future prospects for Regitine are bleak due to the discontinued brand status, generic competition, and narrow indications, leading to an expected decline in revenue.

Sources

  1. Ocuphire Pharma, Inc. - Annual Reports https://www.annualreports.com/HostedData/AnnualReportArchive/o/NASDAQ_OCUP_2022.pdf
  2. Drugs.com - Regitine: Package Insert / Prescribing Information https://www.drugs.com/pro/regitine.html
  3. Allied Market Research - Incretin-Based Drugs Market Statistics, Forecast - 2032 https://www.alliedmarketresearch.com/incretin-based-drugs-market
  4. Karyopharm Therapeutics - First Quarter 2024 Financial Results and Highlights https://investors.karyopharm.com/2024-05-08-Karyopharm-Reports-First-Quarter-2024-Financial-Results-and-Highlights-Recent-Company-Progress

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