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Last Updated: January 4, 2025

DOLISHALE Drug Patent Profile


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

Dolishale is a drug marketed by Novast Labs and is included in one NDA.

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

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Summary for DOLISHALE
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Pharmacology for DOLISHALE

US Patents and Regulatory Information for DOLISHALE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novast Labs DOLISHALE ethinyl estradiol; levonorgestrel TABLET;ORAL 091692-001 Oct 22, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DOLISHALE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Contraceptive Drugs: A Focus on DOLISHALE

Global Contraceptive Drugs Market Overview

The global contraceptive drugs market is experiencing significant growth, driven by increasing awareness and demand for birth control methods. As of 2023, the market was valued at USD 18.57 billion and is projected to reach USD 37.22 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 8.2% during the forecast period of 2024-2032[1].

Market Segmentation and Dominant Segments

The market is segmented by product type, with the oral segment leading due to its higher adoption rates in both developed and developing countries. Oral contraceptives, such as DOLISHALE, offer undue clinical benefits and ease of administration, contributing to their dominance[1].

Distribution Channels

The retail pharmacy segment dominates the global market, driven by the growing demand for over-the-counter (OTC) contraceptive drugs. Countries like Brazil, Mexico, China, and India allow birth control pills to be sold OTC, increasing consumer preference for retail pharmacies. Online channels are also growing rapidly due to their convenience and various online offers[1].

Regional Analysis

North America, particularly the U.S., holds a significant share of the market, valued at USD 7.27 billion in 2023. The region's high awareness about birth control pills and growing childbearing population contribute to its dominance. Europe follows as the second-largest market, while the Asia Pacific region is expected to register the highest CAGR during the forecast period due to government initiatives and increasing awareness about family planning[1].

Product-Specific Analysis: DOLISHALE

Uses and Efficacy

DOLISHALE, a combined oral contraceptive (COC) containing levonorgestrel and ethinyl estradiol, is highly effective for pregnancy prevention. It is indicated for women who elect to use oral contraceptives as a method of contraception. The efficacy of DOLISHALE, like other COCs, depends on the reliability of use, with correct and consistent use resulting in lower failure rates[4].

Dosage and Administration

To achieve maximum contraceptive effectiveness, DOLISHALE must be taken exactly as directed, one green tablet daily without any tablet-free interval. The dosage instructions emphasize the importance of taking the tablets at the same time each day and using a nonhormonal back-up method for the first 7 days if starting the regimen under certain conditions[4][5].

Market Impact

While specific financial data for DOLISHALE is not provided, its market impact can be inferred from the broader trends in the contraceptive drugs market. The increasing preference for OTC drugs and the dominance of the retail pharmacy segment suggest that products like DOLISHALE are likely to see increased demand. The approval of new generic equivalents, such as Lupin’s Drospirenone tablets, also indicates a competitive and growing market[1].

Financial Trajectory

Market Growth Drivers

  • Increasing Awareness and Demand: Growing consumer awareness about birth control pills and other contraceptive methods is a key driver.
  • Regulatory Approvals: New product approvals, such as the FDA approval of Lupin’s Drospirenone tablets, contribute to market growth.
  • Distribution Channels: The expansion of retail pharmacies and online channels enhances accessibility and convenience, driving demand[1].

Competitive Landscape

Top market players like Johnson & Johnson Services, Inc., AbbVie Inc., and Bayer AG focus on strategic collaborations to gain a competitive advantage. The competitive nature of the market, with multiple players and new entrants, is expected to keep prices competitive and drive innovation[1].

Future Outlook

The Asia Pacific region is anticipated to register the highest CAGR during the forecast period, driven by government initiatives and increasing awareness about family planning. This trend suggests that products like DOLISHALE will have significant growth opportunities in these regions.

Key Takeaways

  • The global contraceptive drugs market is projected to grow significantly, reaching USD 37.22 billion by 2032.
  • Oral contraceptives, such as DOLISHALE, dominate the market due to their clinical benefits and ease of administration.
  • Retail pharmacies and online channels are key distribution segments driving market growth.
  • North America and Europe are significant markets, with the Asia Pacific region expected to grow rapidly.
  • New product approvals and strategic collaborations among top players are crucial for market competition.

FAQs

Q1: What is the projected growth rate of the global contraceptive drugs market? The global contraceptive drugs market is projected to grow at a CAGR of 8.2% from 2024 to 2032[1].

Q2: Which segment dominates the global contraceptive drugs market? The oral segment dominates the global market due to the higher adoption of oral drugs in both developed and developing countries[1].

Q3: What are the key distribution channels for contraceptive drugs? The retail pharmacy segment dominates, followed by growing online channels. Other distribution channels include hospital pharmacies, clinics, and public channels & NGOs[1].

Q4: How does DOLISHALE compare in terms of efficacy to other contraceptive methods? DOLISHALE is highly effective for pregnancy prevention, with efficacy rates comparable to other combined oral contraceptives, provided it is used correctly and consistently[4].

Q5: What are the key drivers of the market growth for contraceptive drugs? Key drivers include increasing consumer awareness, regulatory approvals, and the expansion of retail and online distribution channels[1].

Sources

  1. Fortune Business Insights: Global Contraceptive Drugs Market Size, Share | Global Report, 2032
  2. MedOne: Drug Lookup | MedOne - Pharmacy Benefit Solutions
  3. PubMed: The economics of follow-on drug research and development
  4. RxList: Dolishale (Levonorgestrel and Ethinyl Estradiol) - RxList
  5. Drugs.com: Dolishale Dosage Guide - Drugs.com

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