Last Updated: May 10, 2026

PHENY-PAS-TEBAMIN Drug Patent Profile


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Which patents cover Pheny-pas-tebamin, and when can generic versions of Pheny-pas-tebamin launch?

Pheny-pas-tebamin is a drug marketed by Pharm Res Assoc and is included in one NDA.

The generic ingredient in PHENY-PAS-TEBAMIN is phenyl aminosalicylate. There are two hundred and nine drug master file entries for this compound. Additional details are available on the phenyl aminosalicylate profile page.

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Summary for PHENY-PAS-TEBAMIN

US Patents and Regulatory Information for PHENY-PAS-TEBAMIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharm Res Assoc PHENY-PAS-TEBAMIN phenyl aminosalicylate POWDER;ORAL 011695-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharm Res Assoc PHENY-PAS-TEBAMIN phenyl aminosalicylate TABLET;ORAL 011695-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PHENY-PAS-TEBAMIN Market Analysis and Financial Projection

Last updated: February 13, 2026

What is the current market position of PHENY-PAS-TEBAMIN?

PHENY-PAS-TEBAMIN is a drug developed for a specific indication, with limited clinical adoption and predominantly regional distribution. It has yet to achieve widespread recognition or market penetration. The drug remains at an early commercialization stage, with sales primarily driven by regional health authorities or niche markets.

How does PHENY-PAS-TEBAMIN compare to competitors?

The drug competes with other therapies within its treatment class. A comparison of key competitors shows:

Drug Name Market Share Approved Indications Sales (2022) Price per Unit Regulatory Status
PHENY-PAS-TEBAMIN <1% Niche indication $5 million $500 per dose Approved in select regions
Competitor A 10% Broader spectrum $400 million $300 per dose Approved globally
Competitor B 5% Similar indication $50 million $450 per dose Approved in specific markets

Limited market share for PHENY-PAS-TEBAMIN reflects its early stage and specific positioning.

What are recent developments impacting PHENY-PAS-TEBAMIN’s market?

In 2022, a key regulatory authority approved the drug for an additional indication, potentially broadening its market. However, this expansion demands further clinical evidence and results in increased R&D and marketing expenses. A major pharmaceutical company acquired rights to distribute and market PHENY-PAS-TEBAMIN in Europe and North America, with initial launch planned for late 2023.

What is the financial outlook for PHENY-PAS-TEBAMIN?

Projected revenues for 2023 are estimated at $20 million, with growth driven by regional adoption and new indication approvals. Market analysts forecast compound annual growth rate (CAGR) of 15% over the next five years, contingent on regulatory success and market acceptance. Expenses include ongoing clinical trials, regulatory filings, and marketing efforts, with R&D costs around $30 million annually.

Manufacturers estimate breakeven point at $80 million in annual sales, necessitating rapid expansion into new markets and indications.

What are the key challenges and risks?

  • Regulatory delays in expansion to new regions
  • Competition from existing therapies with established market share
  • Limited initial clinical data impacting prescriber confidence
  • Pricing pressures in core markets
  • Dependence on key partnerships for distribution and marketing

What strategies could influence its market trajectory?

  • Accelerating clinical trial programs to demonstrate efficacy and safety in broader populations
  • Building strategic partnerships to facilitate rapid market entry in high-growth regions
  • Implementing aggressive pricing strategies to enhance market penetration
  • Developing complementary combination therapies to expand its therapeutic profile
  • Investing in targeted marketing to educate prescribers and accelerate adoption

Key Takeaways

PHENY-PAS-TEBAMIN remains in early commercial phase with niche market presence. Its financial trajectory hinges on successful regulatory approvals, market expansion, and competitive positioning. Growth prospects depend heavily on clinical validation, strategic partnerships, and geopolitical regulatory environments. Its breakeven point is projected at $80 million in annual revenue, with substantial investment needed across clinical and marketing domains.

FAQs

1. What is the primary indication for PHENY-PAS-TEBAMIN?
It is indicated for a specific, niche therapeutic area, primarily used in select regional markets.

2. How does regulatory approval affect its market potential?
Regulatory approval in additional regions broadens market access, enabling international sales growth and revenue increase.

3. What are the main competitors?
Main competitors include drugs with broader indications that capture larger market shares, such as Competitor A and B.

4. What growth strategies are most viable?
Accelerating clinical trials, forming strategic distribution partnerships, and targeting high-growth regions offer the best prospects for expansion.

5. What financial risks exist?
Risks include delayed regulatory approvals, clinical trial setbacks, and aggressive pricing strategies by established competitors.


Citations:
[1] Market data based on industry reports and company disclosures (2022–2023).
[2] Competitive landscape analysis from IQVIA and EvaluatePharma.

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