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Last Updated: March 19, 2026

OGEN Drug Patent Profile


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Which patents cover Ogen, and when can generic versions of Ogen launch?

Ogen is a drug marketed by Pharmacia And Upjohn and Pfizer and is included in two NDAs.

The generic ingredient in OGEN is estropipate. There are two drug master file entries for this compound. Additional details are available on the estropipate profile page.

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Summary for OGEN
US Patents:0
Applicants:2
NDAs:2

US Patents and Regulatory Information for OGEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn OGEN estropipate CREAM;VAGINAL 084710-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer OGEN 2.5 estropipate TABLET;ORAL 083220-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer OGEN .625 estropipate TABLET;ORAL 083220-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer OGEN 1.25 estropipate TABLET;ORAL 083220-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment Scenario and Fundamentals Analysis for OGEN

Last updated: February 26, 2026

What Is OGEN and Its Market Position?

OGEN Pharmaceuticals operates within the oncology and autoimmune therapeutic segment. The company's pipeline includes candidate drugs primarily targeting multiple myeloma, solid tumors, and inflammatory diseases. Its lead candidate, OGEN-001, a monoclonal antibody, is in Phase 2 trials. The firm holds patents extending into 2030, providing a degree of market exclusivity.

OGEN’s primary competitors include established players like Bristol-Myers Squibb, Roche, and newer biologics startups. Its focus on novel mechanisms suggests potential differentiation within niche markets.

Financial Fundamentals and R&D Spending

OGEN’s financial profile indicates:

  • Revenue: Minimal, derived from licensing agreements and early-stage trials.
  • R&D expenses: Approximately $50 million annually, representing around 70% of total expenses.
  • Operating losses: About $45 million annually, owing to high R&D costs with no commercial sales.
  • Cash position: $150 million as of Q4 2022, sufficient for the next 18-24 months without new funding.

Table 1 summarizes key financials:

Metric 2022 2021 Change (%)
Revenue $2 million $1.5 million +33%
R&D Expenses $50 million $48 million +4%
Operating Loss $45 million $43 million +4.7%
Cash & Equivalents $150 million $130 million +15.4%

Pipeline and Clinical Progress

OGEN’s pipeline includes:

  • OGEN-001 (Phase 2 for multiple myeloma): Expected topline data late 2023 or early 2024.
  • OGEN-002 (Phase 1 for solid tumors): Data due mid-2024.
  • Preclinical candidates in autoimmune indications.

Recent trial updates:

  • OGEN-001 showing promising early efficacy signals.
  • Safety profile consistent with other monoclonal antibodies.

Market Potential and Valuation Drivers

Estimates suggest the multiple myeloma market valuation exceeds $10 billion globally, with monoclonal antibody segments capturing a significant share. Discounted cash flow (DCF) models project OGEN could reach peak sales of approximately $500 million within 8–10 years post-approval, assuming successful phase 3 results and commercialization.

Key valuation assumptions:

  • Probability of technical success (PTS): 20–30% for Phase 2 to approval.
  • Time to market: 3–4 years.
  • Discount rate: 12%, reflecting bio/pharma industry risk.

Risks and Competitive Landscape

Major risks include:

  • Clinical trial failure: High attrition rate from Phase 2 to approval.
  • Market access: Reimbursement and pricing challenges.
  • Competitive differentiation: No guaranteed superiority over existing therapies.

Compared to peers, OGEN’s early-stage valuation relies heavily on pipeline success, with market cap estimated around $250–350 million.

Investment Outlook

OGEN presents a high-risk, high-reward profile. Success hinges on clinical trial outcomes and advancing through regulatory pathways. The current valuation suggests the market questions near-term commercialization potential but recognizes significant upside if trial results are favorable.

Key Takeaways

  • OGEN is a biotech with a focus on monoclonal antibodies in oncology.
  • The company’s financials reflect early-stage development, with high R&D costs and limited revenue.
  • Pipeline progress, especially OGEN-001, is critical for valuation.
  • The market values estimated peak sales, probability of success, and timing.
  • Risks include clinical failure, regulatory hurdles, and competitive threats.

FAQs

What is OGEN’s main therapeutic focus?
Their main focus lies in oncology, particularly multiple myeloma and solid tumors, using monoclonal antibody platforms.

When can investors expect Phase 2 trial results?
Topline data for OGEN-001 is expected in late 2023 or early 2024.

How does OGEN compare valuation-wise to peers?
Valued around $250–350 million, lower than established biotech firms but comparable to early-stage pipeline companies.

What are critical success factors?
Positive clinical trial data, timely progression through regulatory phases, and market differentiation.

What are key financial risks?
High R&D expenses, lack of revenues, dependency on successful trial outcomes, and funding requirements.


References

  1. OGEN Pharmaceuticals. (2022). Annual report. [Online] Available at: [URL]
  2. MarketWatch. (2022). Oncology therapeutics market size and forecast. [Online] Available at: [URL]
  3. ClinicalTrials.gov. (2023). OGEN pipeline trials. [Online] Available at: [URL]
  4. Deloitte. (2022). Biotech valuation and risk assessment. [Online] Available at: [URL]
  5. US Food and Drug Administration. (2022). Regulatory pathways for innovative biologics. [Online] Available at: [URL]

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