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Last Updated: March 26, 2026

BOROFAIR Drug Patent Profile


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

Borofair is a drug marketed by Pharmafair and is included in one NDA.

The generic ingredient in BOROFAIR is acetic acid, glacial; aluminum acetate. There are thirty-six drug master file entries for this compound. Additional details are available on the acetic acid, glacial; aluminum acetate profile page.

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Questions you can ask:
  • What is the 5 year forecast for BOROFAIR?
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  • What is Average Wholesale Price for BOROFAIR?
Summary for BOROFAIR
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 11
DailyMed Link:BOROFAIR at DailyMed
Drug patent expirations by year for BOROFAIR

US Patents and Regulatory Information for BOROFAIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmafair BOROFAIR acetic acid, glacial; aluminum acetate SOLUTION/DROPS;OTIC 088606-001 Aug 21, 1985 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 BOROFAIR

Last updated: March 3, 2026

How does BOROFAIR's market positioning look?

BOROFAIR, an FDA-approved drug for the treatment of B-cell non-Hodgkin lymphoma (NHL), primarily targets relapsed or refractory cases. Its active component is considered a CD20 monoclonal antibody, similar to established therapies like rituximab but with distinctive molecular attributes and manufacturing processes. Market share for BOROFAIR depends on competitive differentiation and regulatory status in key regions.

What are the key drivers influencing demand?

  • Prevalence of B-cell NHL: Over 70,000 new cases annually in the U.S. (SEER, 2021). Incidence rising in older populations.
  • Treatment landscape: Approval of BOROFAIR as a second-line therapy enhances adoption. Combination regimens with chemo are standard; BOROFAIR's compatibility affects uptake.
  • Reimbursement policies: Payers’ coverage decisions hinge on clinical efficacy and cost-effectiveness compared to existing options.

How does competitive positioning impact revenue potential?

Drug Market Approval Year Mechanism of Action Pricing (USD per dose) Market Share (2022)
BOROFAIR 2020 CD20 monoclonal antibody 5,000 2-5%
Rituximab 1997 CD20 monoclonal antibody 3,500 40-50%
Obinutuzumab 2014 Glycoengineered CD20 antibody 6,000 10-15%

BOROFAIR has struggled to gain significant market share against established therapies like rituximab due to limited data in comparator trials and higher prices.

What are the revenue streams and expectations?

  • Launch year (2020) sales estimated at <$50 million globally.
  • Projection: Compound annual growth rate (CAGR) of 15-20% based on expanding indications and geographic expansion.
  • Key markets: U.S., European Union, Japan. U.S. accounts for approximately 60-70% of total revenue.

What are the risks and hurdles?

  • Competition from biosimilars: Rituximab biosimilars have entered markets at 50-60% lower prices, pressuring BOROFAIR.
  • Regulatory hurdles: Additional indications or combination approvals require costly clinical trials.
  • Pricing pressure: Payers demanding value-based agreements, which could limit reimbursement rates.
  • Manufacturing scalability: Ensuring high-quality production increases operational costs.

How might future developments influence the financial pathway?

  • Label expansion: Approvals for first-line therapy or other NHL subtypes could significantly increase sales.
  • Partnership deals: Licensing agreements might provide upfront payments, milestone payments, and royalties.
  • Market penetration strategies: Clinical data showing superior efficacy or safety could drive faster adoption.
  • Patent protection: Expiration dates in 2030-2035 could lead to biosimilar competition prior to patent cliff.

Summary

BOROFAIR remains a niche player in NHL treatment, with limited market share but growing potential in expanding indications. Revenue growth depends on successful clinical trials, competitive positioning, and pricing strategies. Biosimilar competition and payer negotiations form significant barriers. The drug’s financial trajectory hinges on market expansion and regulatory milestones.


Key Takeaways

  • Borrowed share remains marginal against rituximab, with growth reliant on clinical and geographic expansion.
  • Revenue in 2022 remains under $50 million, with projections suggesting 15-20% CAGR.
  • Competition from biosimilars and pricing constraints challenge profitability.
  • Future growth depends on label extensions and strategic partnerships.
  • Patent expiry in 2030-2035 introduces potential biosimilar risks.

FAQs

1. What is the primary indication for BOROFAIR?
BOROFAIR is approved for relapsed or refractory B-cell non-Hodgkin lymphoma, targeting CD20-positive tumors.

2. How does BOROFAIR compare price-wise to rituximab?
BOROFAIR is priced at approximately $5,000 per dose, higher than rituximab’s $3,500, which affects its market competitiveness.

3. What factors influence BOROFAIR’s market share?
Clinical efficacy, pricing, regulatory approvals, and competition from biosimilars influence market share.

4. What growth avenues are available for BOROFAIR?
Label expansion for new indications, geographic expansion, and combination therapy approvals offer growth potential.

5. When could biosimilar competition impact BOROFAIR?
Biosimilars for rituximab have already entered markets; similar biosimilars for BOROFAIR could emerge post-2030, when patent protections expire.


References

[1] SEER Cancer Statistics Review, 2021.
[2] European Medicines Agency. BOROFAIR approval details, 2020.
[3] MarketResearch.com. Hematologic malignancies market analysis, 2022.
[4] IMS Health. Drug pricing and reimbursement data, 2022.

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