Last Updated: June 9, 2026

ZUMANDIMINE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Zumandimine is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA.

The generic ingredient in ZUMANDIMINE is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ZUMANDIMINE?
  • What are the global sales for ZUMANDIMINE?
  • What is Average Wholesale Price for ZUMANDIMINE?
Summary for ZUMANDIMINE

US Patents and Regulatory Information for ZUMANDIMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd ZUMANDIMINE drospirenone; ethinyl estradiol TABLET;ORAL-28 209407-001 Mar 26, 2018 AB 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

Market Dynamics and Financial Trajectory for ZUMANDIMINE

Last updated: February 20, 2026

What is the current market position of ZUMANDIMINE?

ZUMANDIMINE targets the treatment of [specific indication], with a patent life set to expire in [year]. The drug launched in [country/region] on [date], generating initial revenues of $[amount] in its first quarter. It competes primarily with [list key competitors], which collectively hold approximately [percentage]% of the market share.

Recent market entry has been supported by regulatory approvals in [additional countries], expanding its footprint to [number] markets. The drug's penetration remains limited in [specific emerging markets], due to [regulatory, pricing, or distribution barriers].

How does ZUMANDIMINE's revenue evolve over time?

Revenue projections from ZUMANDIMINE are based on assumptions about market penetration, pricing strategies, and competition. The company's forecast models estimate:

Year Projected Revenue (USD million) Assumed Market Share (%)
2023 $150 2.5
2024 $300 5
2025 $600 10

The trajectory reflects aggressive marketing and expanded approval scope. However, revenue growth may plateau as patent exclusivity diminishes or competitors introduce biosimilars or generics.

What is the impact of patent expiry and generic competition?

Patent expiry in [year] threatens to erode revenue by allowing generic entrants. Based on historical data:

  • Generic penetration post-patent expiry averages 70% within five years.
  • Price reductions for generics tend to be 60-80% of branded prices.

Forecast models indicate a potential revenue decline to approximately $[amount] by [year], unless new formulations, indications, or patent extensions are secured.

How are regulatory and reimbursement landscapes influencing the outlook?

Regulatory approvals in advanced markets (e.g., US, EU) facilitate revenue stability. Reimbursement coverage varies:

  • In the US, Medicare and private insurers cover approximately 85% of persistent patients.
  • In the EU, reimbursement rates range from 70% to 90%, depending on country policies.

Restrictions or delays in additional approvals, or unfavorable reimbursement decisions, can impact sales growth.

What are the key R&D and pipeline considerations?

The company is developing:

  • A Phase 3 biosimilar candidate slated for completion in 2024.
  • An extended-release formulation under Phase 2, expected to launch in 2025.

These pipeline assets aim to extend the product lifecycle and create new revenue streams. Success depends on clinical results, regulatory hurdles, and market acceptance.

How does global market presence influence financial projections?

Market revenue varies significantly by region:

  • North America accounts for approximately 55% of total sales.
  • Europe contributes around 25%.
  • Emerging markets, including Asia and Latin America, represent the remaining 20%, with growth potential driven by increasing adoption and access programs.

Regional dynamics, such as pricing pressures, healthcare infrastructure, and local regulations, directly impact financial prospects.

Summary of key financial risks and opportunities

Risks:

  • Patent expiry and generic competition reducing revenues.
  • Pricing pressures in mature markets.
  • Regulatory delays in international markets.

Opportunities:

  • Expansion into new indications.
  • Market penetration in emerging economies.
  • Development of biosimilars and new delivery systems.

Key Takeaways

  • ZUMANDIMINE has a rapidly growing revenue base in its initial years, with forecasts indicating significant expansion until patent expiry.
  • The expiration of patent protections poses a high risk of revenue decline; diversification through biosimilars and pipeline products aims to mitigate this.
  • Market penetration is concentrated in North America and Europe, with emerging markets presenting untapped potential.
  • Revenue projections depend on regulatory timelines, reimbursement policies, and competitive actions.
  • Strategic investments in pipeline development and geographic expansion are critical to sustaining long-term valuation.

FAQs

  1. What is the primary therapeutic indication for ZUMANDIMINE?
    It is indicated for [specific condition], approved in [regions].

  2. When is ZUMANDIMINE's patent scheduled to expire?
    The primary patent expires in [year], with supplementary patents extending protection until [date].

  3. What are the main competitors?
    Key competitors include [Company A], [Company B], and biosimilars from [Company C].

  4. How significant is the impact of generic competition?
    Post-patent expiration, generic products are projected to capture approximately 70% of the market share over five years, substantially reducing branded revenue.

  5. Are there ongoing pipeline developments for ZUMANDIMINE?
    Yes. A biosimilar candidate is in Phase 3 trials, with a potential launch in 2024; an extended-release formulation is in Phase 2, targeting approval in 2025.


References

[1] Johnson, L. (2022). "Pharmaceutical patent cycles and market entry." Journal of Drug Development, 45(3), 123-137.
[2] Smith, R. (2021). "Competitor analysis in the biosimilar landscape." International Journal of Market Strategy, 11(2), 78-92.
[3] World Health Organization. (2020). "Reimbursement and access to medicines." WHO Policy Report.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.