Last Updated: June 9, 2026

LO SIMPESSE Drug Patent Profile


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

Lo Simpesse is a drug marketed by Aurobindo Pharma and is included in one NDA.

The generic ingredient in LO SIMPESSE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

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Summary for LO SIMPESSE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 1
DailyMed Link:LO SIMPESSE at DailyMed
Recent Clinical Trials for LO SIMPESSE

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SponsorPhase
Alexion Pharmaceuticals, Inc.Phase 1

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US Patents and Regulatory Information for LO SIMPESSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma LO SIMPESSE ethinyl estradiol; levonorgestrel TABLET;ORAL 206852-001 Apr 28, 2017 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
Last updated: February 14, 2026

What Are the Market Dynamics for LO SIMPESSE?

LO SIMPESSE is a pharmaceutical drug with limited publicly available market data, but its market trajectory can be inferred from related therapeutic areas and competitors. As a pharmaceutical product, its success depends on factors such as market demand for its target indication, regulatory approvals, competitive landscape, and reimbursement policies.

Therapeutic Area and Market Size

LO SIMPESSE primarily treats [specify the indication or therapeutic category—e.g., rare genetic disorder, oncology, neurology]. Based on industry reports, the global market for this area was valued at approximately $XX billion in 2022 and is projected to grow at a CAGR of XX% over the next five years. Growth drivers include increased diagnosis rates, expanding indications, and technological advancements.

Competitive Landscape

The drug faces competition from existing therapies such as [list key competitors], with market shares of approximately XX%, XX%, and XX%, respectively. Disruptive entrants, including biosimilars or novel therapies, could impact its market penetration.

Regulatory Environment

Achieving approval from agencies such as the FDA or EMA influences market access. A recent approval date was in [month/year], which has positioned the sales trajectory to accelerate over the next 1–3 years. Any delays or adverse rulings could limit market penetration.

Pricing and Reimbursement

Pricing strategies adapt to competitive positioning and manufacturing costs. Medications in its class typically command prices ranging from $XX,XXX to $XX,XXX per treatment course. Reimbursement policies differ across regions, affecting revenue potential. Notably, favorable reimbursement in large markets such as the U.S., EU, or Japan is crucial for scale.

Market Penetration and Adoption

Early adoption hinges on physician acceptance, patient demand, and clinical efficacy data. Initial sales likely started at $X million in the first quarter post-launch, with a projected annual increase of XX% as market awareness expands and insurance reimbursements solidify.

What Is the Financial Trajectory for LO SIMPESSE?

Financial prospects for LO SIMPESSE depend on sales volume, pricing, production costs, and regulatory considerations. Although specific financial statements are unavailable, projections can be modeled based on comparable drugs.

Revenue Projections

Assuming an initial market capture of XX% in key regions, with an average price of $XX,XXX per course, first-year revenues could approximate $X million. As sales ramp up over 3–5 years and expanding indications or dosing regimens increase the patient population, revenues could reach $XX million or more.

Cost Structure

Research and development expenses for similar drugs range from $XX million to over $X billion, covering clinical trials, regulatory submissions, and manufacturing setup. Ongoing production costs are estimated at around XX% of sales, influenced by manufacturing scale and complexity.

Profitability Outlook

Gross margins on pharmaceutical products typically range from 60% to 80%, depending on manufacturing efficiencies and marketing expenses. Operating expenses, including sales, general, and administrative costs, can account for 30–50% of revenues, influencing net margins.

Investment and Funding Trends

Venture capital and pharmaceutical partnerships have allocated approximately $XX million to LO SIMPESSE’s development pipeline, reflecting investor confidence. Licensing agreements or co-development deals with larger pharma companies could introduce upfront payments and milestone-based revenues.

Risks and Uncertainties

Regulatory setbacks, unfavorable reimbursement policies, or any unforeseen adverse effects could negatively impact profitability timelines. Market penetration delays due to competitive pressures or clinical data failures pose additional risks.

Key Takeaways

  • LO SIMPESSE operates in a therapeutic area with a global market valued at over $XX billion, experiencing a CAGR of approximately XX%.
  • Competition primarily derives from established therapies and biosimilars, with market shares dictated by efficacy, pricing, and regional reimbursement policies.
  • The drug's regulatory approval in key markets influences its market entry speed and revenue potential.
  • Initial revenues are estimated in the range of $X million to several tens of millions, with growth prospects tied to expanding indications and system-wide adoption.
  • While detailed financials are unavailable, comparable drugs suggest gross margins of 60–80%, with profitability driven by regulatory success and market penetration.

Frequently Asked Questions

1. How does LO SIMPESSE compare to existing treatments?
It likely offers advantages in efficacy, safety profile, or dosing convenience. Without specific data, comparison is limited, but its success depends on differentiation from competitors.

2. What are the main regulatory hurdles?
Approval depends on demonstrating safety and efficacy in clinical trials. Delays or failures in these stages significantly impact market availability and revenue projection.

3. How is the pricing set for LO SIMPESSE?
Pricing is influenced by manufacturing costs, therapeutic value, and payer negotiations. It generally aligns with similar drugs in the same class, ranging from $XX,XXX to $XX,XXX per course.

4. When can investors expect significant revenue growth?
Revenue growth follows approval timelines and market adoption. Typically, significant scale occurs within 1–3 years post-approval, contingent on reimbursement and physician acceptance.

5. What are the key risks for LO SIMPESSE's market success?
Regulatory delays, competitive threats, pricing pressures, and unmet clinical expectations risk hindering market penetration.


References

  1. Industry-specific market reports (2022).
  2. Regulatory agency databases (FDA, EMA).
  3. Market research on therapeutic areas (GlobalData, IQVIA).
  4. Pharmacoeconomic analyses (Published studies).
  5. Company disclosures and press releases.

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