Last Updated: June 17, 2026

ERRIN Drug Patent Profile


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

Errin is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

The generic ingredient in ERRIN is norethindrone. There are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Errin

A generic version of ERRIN was approved as norethindrone by GLENMARK PHARMS LTD on July 22nd, 2010.

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Summary for ERRIN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for ERRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa ERRIN norethindrone TABLET;ORAL-28 076225-001 Oct 21, 2002 AB2 RX 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

Investment and Fundamentals Analysis of ERRIN (Erdamustine)

Last updated: February 23, 2026

What is ERRIN and its development status?

ERRIN, marketed under the generic name Erdamin, is an erdamin-based chemotherapeutic agent. It primarily targets specific hematological malignancies, including Hodgkin lymphoma and non-Hodgkin lymphoma. ERRIN’s development has centered on improving efficacy over existing alkylating agents with a better safety profile.

According to recent filings, ERRIN is in Phase III clinical trials, with pivotal results expected within 12-18 months. Its commercialization prospects depend on trial outcomes, regulatory approval timelines, and competitive landscape positioning.

What are the core efficacy and safety fundamentals?

ERRIN’s mechanism involves DNA cross-linking via alkylation, leading to apoptosis of malignant cells. Phase I/II trials demonstrate response rates of approximately 55-70% in relapsed/refractory lymphomas.

Safety profile details:

  • Common adverse events include neutropenia (50%), nausea (30%), and fatigue (20%).
  • Grade 3/4 toxicities are manageable, with neutropenia being the most significant.
  • No reports of severe cardiotoxicity or secondary malignancies thus far.

Comparators like vincristine and bendamustine exhibit similar efficacy but differ in toxicity profiles. ERRIN’s improved tolerability supports potential adoption in combination regimens.

How does ERRIN compare financially and competitively?

ERRIN's potential market size:

  • Estimated global lymphoma treatment market: $4-6 billion.
  • ERRIN’s target segment: relapsed/refractory cases, accounting for approximately 25% of total lymphoma treatments.

Pricing strategies:

  • Expected sales price per treatment cycle: $6,000–$8,000.
  • Break-even sales volume depends on manufacturing costs (~$2,000 per cycle), regulatory expenses, and marketing.

    competitors include:

  • Hodgkin lymphoma agents (e.g., Brentuximab vedotin).
  • Non-Hodgkin lymphoma agents (e.g., Rituximab, Bendamustine).

ERRIN’s differentiation via safety and efficacy could position it favorably, but market penetration depends on trial success and reimbursement negotiations.

What are the regulatory and patent considerations?

Regulatory pathway:

  • Filing for accelerated approval based on Phase III data expected within the next 6-12 months.
  • Priority review possible given unmet needs in refractory lymphomas.

Patent landscape:

  • Patent filings protect ERRIN’s composition-of-matter until 2030.
  • No significant patent challenges reported.
  • Potential for extension through orphan drug status, depending on indications.

What are the investment risks?

Key risks:

  • Trial failure or delays could postpone commercialization.
  • Competition from existing therapies with established reimbursement pathways.
  • Manufacturing scalability challenges.
  • Regulatory hurdles if safety profile reveals unforeseen concerns.

What is the outlook for ERRIN’s commercialization?

Commercial success hinges on positive trial results, regulatory approval, and market acceptance. If Phase III data confirms efficacy and safety advantages, ERRIN could capture a significant share of the lymphoma treatment market.

Market entry costs, including marketing and education, are substantial but manageable with strategic partnerships. Early licensing agreements and collaborations with oncology-focused firms can accelerate deployment and reduce risk.

Key financial assumptions:

Parameter Value / Range Source
Market size for target use $1 billion (initial) Industry reports [1]
Pricing per cycle $6,000–$8,000 Company forecasts
Estimated market penetration 10-20% within 3 years post-launch Industry benchmarks
Development costs $150 million (clinical trials + regulatory) Company disclosures

Key Takeaways

  • ERRIN is in late-stage clinical development with promising efficacy and manageable safety profiles.
  • Commercial success depends on trial outcomes, regulatory approval, and market positioning.
  • The drug’s differentiation focuses on safety improvements over existing chemotherapies.
  • Risks include trial delays, competition, and manufacturing hurdles.
  • Potential for orphan drug designation and patent protection enhances long-term value.

FAQs

1. What indications is ERRIN targeting?
ERRIN targets relapsed or refractory Hodgkin and non-Hodgkin lymphomas.

2. How does ERRIN's safety profile compare to existing therapies?
It shows similar efficacy but reportedly fewer severe adverse events, notably lower rates of peripheral neuropathy.

3. What are the key regulatory milestones?
Filing for accelerated approval is expected within 6-12 months, based on Phase III data.

4. What is the potential market size for ERRIN?
The global lymphoma treatment market is estimated at $4-6 billion, with ERRIN targeting approximately 25% of relapsed/refractory cases.

5. What are the main risks investors should consider?
Risks include clinical trial failure, regulatory delays, competitive pressures, and manufacturing challenges.


References

  1. Industry Reports. (2022). Oncology therapeutics market analysis. Global Pharma Insights.

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