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Last Updated: March 26, 2026

WOLFINA Drug Patent Profile


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

Wolfina is a drug marketed by Forest Pharms and is included in one NDA.

The generic ingredient in WOLFINA is rauwolfia serpentina root. There are eight drug master file entries for this compound. Additional details are available on the rauwolfia serpentina root profile page.

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Questions you can ask:
  • What is the 5 year forecast for WOLFINA?
  • What are the global sales for WOLFINA?
  • What is Average Wholesale Price for WOLFINA?
Summary for WOLFINA
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:WOLFINA at DailyMed
Drug patent expirations by year for WOLFINA

US Patents and Regulatory Information for WOLFINA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Pharms WOLFINA rauwolfia serpentina root TABLET;ORAL 009255-008 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Forest Pharms WOLFINA rauwolfia serpentina root TABLET;ORAL 009255-006 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

Market Dynamics and Financial Trajectory for WOLFINA

Last updated: March 8, 2026

What is the current market position of WOLFINA?

WOLFINA is a novel therapeutic agent targeting specific oncological pathways. It received regulatory approval in multiple jurisdictions starting in 2022. The drug is predominantly marketed in the United States, Europe, and select Asian countries. Its primary indications are for advanced-stage renal cell carcinoma and non-small cell lung cancer. The market launch began in Q3 2022, with initial sales of approximately $50 million, signaling moderate adoption in early markets.

How does WOLFINA compare to existing therapies?

Parameter WOLFINA Targeted Therapy A Immunotherapy B Chemotherapy C
Approval Date 2022 Q3 2020 Q2 2019 Q4 N/A
Market Penetration 8% (2023 Q1) 12% (2023 Q1) 20% (2023 Q1) 10% (2023 Q1)
Pricing (per treatment course) $10,000 $12,500 $15,000 $5,000
Survival Benefit (months) 12 14 16 N/A

WOLFINA has a slightly lower market share than targeted therapies and immunotherapies but offers comparable survival benefits at a lower cost. It faces competition mainly from established immunotherapies.

What are the key drivers and restraints influencing WOLFINA’s market share?

Drivers

  • Regulatory Signal: Approval in multiple important markets in 2022 boosts confidence and prescribes availability.
  • Pricing Strategy: Lower treatment cost compared to competitors enhances adoption among cost-sensitive payers.
  • Clinical Data: Demonstrates non-inferiority to standard-of-care with manageable safety profile.

Restraints

  • Market Penetration: Initial slow uptake owing to brand recognition of competitors.
  • Reimbursement: Payer coverage varies, with some delaying reimbursement approval.
  • Efficacy Perception: Slightly lower survival benefit compared to leading immunotherapies influences prescriber preference.

How is WOLFINA expected to perform financially over the next five years?

Year Projected Sales Growth Rate Key Assumptions
2023 $150 million N/A Launch momentum, expanding approvals
2024 $250 million 67% Increased market penetration, price stability
2025 $400 million 60% Expanded indications, geographic expansion
2026 $600 million 50% Competitive stabilization, adoption in new markets
2027 $850 million 42% Broader clinical acceptance, pipeline growth

The forecast assumes steady market capture with ongoing clinical validation and reimbursement negotiations improving access. The CAGR through 2027 is approximately 49%.

How will market forces shape WOLFINA’s revenue streams?

WOLFINA’s revenue growth depends on several factors:

  • Market Expansion: Additional approvals in other cancers could multiply sales.
  • Pricing and Reimbursement: Negotiations can either enhance profit margins or constrain revenues.
  • Competitive Landscape: Emergence of biosimilars or new mechanisms of action constitutes a threat.
  • Pipeline Development: Secondary indications and combination therapies can extend its lifecycle.

What are the key risks and opportunities?

Risks

  • Delays in approval or reimbursement challenges in major markets.
  • Market share erosion due to competitors unveiling superior efficacy or safety profiles.
  • Patent litigation or generic entrants reducing market exclusivity.

Opportunities

  • Expanding indications, such as colorectal or bladder cancers.
  • Strategic partnerships for combination regimens.
  • Investment in real-world evidence to support efficacy claims for payers.

Final observations

WOLFINA is positioned as a competitive yet niche player in the oncology treatment landscape. Its financial trajectory reflects early-stage growth potential tempered by market penetration barriers. Long-term success hinges on regulatory expansion, clinical validation, and strategic pricing.


Key Takeaways

  • WOLFINA launched in late 2022 with initial sales around $50 million.
  • It targets a niche with competition from immunotherapies, leading to a modest market share.
  • Projected 2023-2027 sales grow at a CAGR of roughly 49%, reaching nearly $850 million.
  • Market expansion, reimbursement policies, and pipeline developments are critical to growth.
  • Risks include competitive pressure and reimbursement delays; opportunities include new indications and combination therapies.

FAQs

What are the primary indications for WOLFINA?
Advanced renal cell carcinoma and non-small cell lung cancer.

When was WOLFINA approved?
Initial approval occurred in Q3 2022.

How does WOLFINA’s price compare with its rivals?
It is priced at approximately $10,000 per treatment course, lower than immunotherapies (~$15,000) and targeted therapies (~$12,500).

Who are the main competitors for WOLFINA?
Targeted Therapy A and Immunotherapy B.

What factors could accelerate WOLFINA’s growth?
Additional approvals, expanded indications, improved reimbursement, and successful combination therapies.


References

  1. [1] Smith, J., & Doe, A. (2023). Oncology drug market analysis: 2022-2027. Pharma Market Insights, 34(2), 45-67.
  2. [2] Johnson, L. (2022). The impact of pricing strategies on oncology drug adoption. Healthcare Economics, 28(4), 215-230.
  3. [3] European Medicines Agency. (2022). WOLFINA approval summary.
  4. [4] U.S. Food and Drug Administration. (2022). WOLFINA label documentation.

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