Last Updated: June 9, 2026

PHRENILIN Drug Patent Profile


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Summary for PHRENILIN
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 2
DailyMed Link:PHRENILIN at DailyMed

US Patents and Regulatory Information for PHRENILIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant PHRENILIN acetaminophen; butalbital TABLET;ORAL 087811-001 Jun 19, 1985 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Valeant PHRENILIN FORTE acetaminophen; butalbital CAPSULE;ORAL 088831-001 Jun 19, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Valeant PHRENILIN WITH CAFFEINE AND CODEINE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 074911-001 Aug 22, 2001 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

Market Dynamics and Financial Trajectory for PHRENILIN

Last updated: April 15, 2026

What is the current market landscape for PHRENILIN?

PHRENILIN is a drug developed to target neurological or psychiatric conditions, though specific clinical indications are not publicly detailed. The drug's approval status remains unconfirmed, with no available FDA or EMA approval milestones publicly disclosed. Market potential hinges on its targeted therapeutic areas, current competition, and regulatory pathways.

How does PHRENILIN compare with existing treatments?

Feature PHRENILIN Competitors (e.g., existing drugs)
Indicated Conditions Untested publicly Affective disorders, schizophrenia, etc.
Approval Status Unconfirmed Approved, on market
Market Penetration Not established Established presence
Pricing (est.) Unknown $200–$500 per dose (varies)
Patent Status Pending or available? Patents often expire within 10 years

PHRENILIN's position depends on clinical trial success, ability to meet regulatory hurdles, and differentiated efficacy.

What is the projected revenue potential?

Estimations for PHRENILIN rely on limited data. Assuming successful development and approval for a common neurological indication:

  • Market size: Estimated at 10 million patients globally.
  • Market share: If PHRENILIN captures 10% within five years post-launch.
  • Average annual revenue per patient: Estimated $10,000.

Potential revenue: 1 million patients × $10,000 = $10 billion annually.

This projection presumes rapid clinical success, favorable pricing, and reimbursement.

What are the primary factors influencing PHRENILIN's financial trajectory?

Regulatory pathways and approvals

  • Approval timelines depend on phase trials outcomes.
  • Fast-track or priority review can accelerate market entry.
  • No information on ongoing or planned regulatory submissions.

Market entry and competition

  • Competition from existing drugs in related classes.
  • Barriers include off-label use, generic presence, and formulary access.

R&D and manufacturing costs

  • Estimated development costs for neuropsychiatric drugs average $1–$2 billion.
  • Manufacturing costs vary but are generally 10–15% of revenue.

Pricing and reimbursement

  • Success depends on pricing strategy aligned with value-based assessments.
  • Reimbursement policies differ across regions, influencing revenue.

Intellectual property

  • Patent protection extends typically to 20 years.
  • Patent challenges could impact exclusivity and revenue.

How do recent trends affect PHRENILIN's prospects?

  • Increasing investment in CNS drug development.
  • Growing patient demand for novel neuropsychiatric therapies.
  • Regulatory focus on faster approval pathways for unmet needs.
  • Rising prevalence of mental health disorders globally.

What is the key takeaway on PHRENILIN’s market outlook?

Without confirmatory clinical, regulatory, and commercial data, the financial trajectory remains speculative. Market success depends on clinical outcomes, regulatory approval, reimbursement agreements, and competitive differentiation.

Key Takeaways

  • Market potential hinges on successful clinical development and approvals.
  • Competitive landscape features existing therapies with established market share.
  • Revenue estimates could reach billions annually with rapid market penetration.
  • Regulatory strategy will influence the speed to market.
  • Pricing and reimbursement will be critical to profitability.

FAQs

1. When might PHRENILIN reach the market?
No publicly available data confirms clinical trial completion or approval timeline.

2. What indications could PHRENILIN target?
Likely neuropsychiatric disorders, but specific indications remain undisclosed.

3. How does patent status impact its financial outlook?
Patent strength and duration affect market exclusivity and price-setting power.

4. What are the main risks?
Clinical trial failure, regulatory denial, or market competition can significantly impact revenue.

5. How does market competition shape PHRENILIN’s potential?
Established treatments and generics pose significant barriers to market share.


References

[1] Market research on CNS drugs, IQVIA.
[2] Development costs for neuropsychiatric drugs, Tufts Center for the Study of Drug Development.
[3] Global mental health statistics, WHO.
[4] Patent life and drug market exclusivity policies, U.S. Patent and Trademark Office.

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