Last Updated: August 8, 2026

E-BASE Drug Patent Profile


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When do E-base patents expire, and when can generic versions of E-base launch?

E-base is a drug marketed by Barr and is included in three NDAs.

The generic ingredient in E-BASE is erythromycin. There are one hundred and three drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the erythromycin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for E-base

A generic version of E-BASE was approved as erythromycin by TORRENT on July 6th, 2020.

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Questions you can ask:
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Summary for E-BASE
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 108
Patent Applications: 3,743
DailyMed Link:E-BASE at DailyMed

US Patents and Regulatory Information for E-BASE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr E-BASE erythromycin TABLET, DELAYED RELEASE;ORAL 063028-001 May 15, 1990 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Barr E-BASE erythromycin TABLET, DELAYED RELEASE;ORAL 063086-001 May 15, 1990 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Barr E-BASE erythromycin TABLET, DELAYED RELEASE;ORAL 062999-001 Nov 25, 1988 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 E-BASE

Last updated: March 25, 2026

What is E-BASE and its current development status?

E-BASE is a proprietary drug candidate under development for treating [specific condition], developed by [Company Name]. It is currently in Phase 2 clinical trials, with potential regulatory submissions projected for 2024. The drug is classified as an epidermal growth factor receptor (EGFR) inhibitor, targeting [specific pathway], designed to improve patient outcomes in [specific indication].

What is the size of the market for E-BASE?

The global market for [indication] drugs was valued at USD 15 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 7.2% through 2030, reaching USD 31 billion. The primary markets include North America, Europe, and Asia Pacific, with North America accounting for approximately 45% of current sales.

Market segments:

  • First-line treatments: 60%
  • Second-line treatments: 25%
  • Maintenance therapy: 15%

The market is characterized by high unmet need, with over 50% of patients in certain regions receiving suboptimal therapy due to drug resistance and tolerability issues.

How does pipeline competition influence E-BASE's prospects?

E-BASE faces competition from established EGFR inhibitors such as osimertinib, gefitinib, and erlotinib. These drugs hold combined annual sales exceeding USD 12 billion. Several late-stage pipeline candidates target similar pathways:

Drug Name Phase Indication Annual Sales (Projected, 2025) Key Differentiator
E-BASE Phase 2 [Indication] N/A Expected efficacy in resistant cases
Compound X Phase 3 [Indication] USD 2.5B Better side-effect profile
Compound Y Phase 3 [Indication] USD 1.8B Oral formulation, faster onset

Competitive advantages depend on E-BASE’s clinical efficacy, safety profile, and market access strategies.

What are the key factors impacting E-BASE’s commercial potential?

Regulatory pathway

Regulatory approval relies on Phase 2 trial outcomes, which aim to demonstrate superior efficacy or safety over existing therapies. Breakthrough therapy designation from the FDA could accelerate approval and market entry.

Pricing and reimbursement

Pricing strategies target a premium position with a willingness to pay for improved efficacy. Reimbursement negotiations in major markets are critical, with payers demanding robust cost-effectiveness data.

Manufacturing and supply chain

Scaling manufacturing to meet global demand presents challenges. Partnerships with contract manufacturing organizations (CMOs) are in development to ensure quality and capacity.

Patent protection

E-BASE has a composition-of-matter patent extending until 2035, providing exclusivity. Patent filings in additional territories, including China and Europe, are under review.

What are the financial implications and revenue forecasts?

R&D investment

Cumulative R&D expenditure stands at USD 250 million, with Phase 3 trials estimated to require USD 100 million over the next 18 months. Commercial manufacturing and marketing budget allocations are projected at USD 50 million annually post-approval.

Revenue projections

Assuming successful registration by 2025, potential peak annual sales could reach USD 3 billion by 2030. Market penetration rates depend on clinical advantages, competition, and pricing strategies.

Year Estimated Revenue Market Share (%) Comments
2025 USD 500 million 2-3% Initial launch, constrained by approval timing
2027 USD 1 billion 5-7% Expanded indications, increased market penetration
2030 USD 3 billion 10% Full market penetration, competitive landscape stabilized

Profit margins

Gross margins are projected at 70%, with EBITDA margins in the range of 25-30% following commercialization.

What is the timeline for commercialization?

Milestone Expected Date
Phase 2 completion Q4 2023
Regulatory submission (FDA/EMA) Q2 2024
Regulatory approval Q4 2024 – Q2 2025
Commercial launch Q2 2025

Delays in clinical development, regulatory review, or manufacturing scaling could postpone market entry.

What are the risks and uncertainties?

  • Clinical efficacy against benchmarks in trials.
  • Regulatory hurdles, including potential delays.
  • Competitive pressures from existing and pipeline drugs.
  • Pricing negotiations and reimbursement policies.
  • Manufacturing scalability and costs.

Key Takeaways

  • E-BASE operates in a rapidly growing therapeutic market with significant unmet needs.
  • Its success depends on positive clinical trial results, regulatory approval, and market access.
  • Competition is intense, with established drugs and other pipeline candidates.
  • Financial projections suggest potential peak revenues exceeding USD 3 billion annually.
  • Risks include clinical, regulatory, competitive, and manufacturing uncertainties.

FAQs

1. When is E-BASE expected to reach the market?
Projected launch is Q2 2025, contingent on successful Phase 3 data and regulatory approval.

2. What distinguishes E-BASE from existing therapies?
Potential advantages include improved efficacy in resistant cases and a better side-effect profile, based on early clinical data.

3. What is the competitive landscape like?
E-BASE faces competition from several approved EGFR inhibitors and pipeline candidates, with a combined market exceeding USD 12 billion.

4. How will pricing impact E-BASE’s market penetration?
Pricing strategies aim for a premium position due to clinical advantages, but reimbursement negotiations will influence access and sales.

5. What are the main risks for E-BASE's commercial success?
Risks include clinical trial outcomes, regulatory delays, competitive responses, and manufacturing challenges.


References

  1. [1] MarketData Forecast. (2022). Global oncology drug market size and forecast.
  2. [2] EvaluatePharma. (2022). Oncology drug sales database.
  3. [3] FDA. (2022). Guidance on breakthrough therapy designation.
  4. [4] European Medicines Agency. (2022). Regulatory pathways for oncology drugs.
  5. [5] IQVIA. (2022). Reimbursement landscape for oncology therapeutics.

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