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Last Updated: June 14, 2025

Drugs in MeSH Category Contraceptives, Oral, Synthetic


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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Ltd NORETHINDRONE norethindrone TABLET;ORAL-28 091209-001 Jul 22, 2010 AB2 RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Usl Pharma MEGESTROL ACETATE megestrol acetate TABLET;ORAL 070647-001 Oct 2, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 204688-001 Dec 1, 2017 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Contraceptives, Oral, Synthetic Market Analysis and Financial Projection

The market for synthetic oral contraceptives is shaped by evolving formulations, patent strategies, and shifting regulatory landscapes. Here’s a detailed analysis:


Market Dynamics

  1. Growth Projections
    The global oral contraceptive pills market reached $17.9 billion in 2022 and is projected to grow at a 7.25% CAGR through 2031, driven by rising demand for pregnancy prevention and expanded insurance coverage[6][9]. Key drivers include:

    • Increasing adoption of novel products (e.g., progestin-only pills)
    • Public health campaigns promoting contraceptive awareness[2][13].
    • Over-the-counter (OTC) approvals like Opill, the first non-prescription contraceptive pill in the U.S.[9][13].
  2. Market Segmentation

    • By product: Combined estrogen-progestin pills dominate (63% market share), while progestin-only formulations are gaining traction[2][6].
    • By region: North America leads with $7.27 billion in 2023, fueled by robust healthcare infrastructure and high consumer spending[2][9].
  3. Key Players
    Top innovators include Bayer AG, Johnson & Johnson, and Merck, with newer entrants like Mithra introducing patented formulations (e.g., NEXTSTELLIS®, combining estetrol and drospirenone)[8].


Patent Landscape

  1. Innovation Trends
    Patents focus on:

    • Dosing regimens: Triphasic oral contraceptives (e.g., US6214815B1) using staggered estrogen-progestin combinations[1][5].
    • Hormonal blends: Combining synthetic progestins (e.g., norelgestromin) with lower estrogen doses to reduce thromboembolism risks[17][18].
    • Non-daily formulations: Pericoital (on-demand) pills like levonorgestrel 1.5 mg, designed for use before/after intercourse[15].
  2. Legal Challenges

    • Patent disputes: Bayer’s Yaz® patent (RE37,564) was invalidated in 2013 due to obviousness, highlighting vulnerabilities in incremental innovation[12].
    • Regional strategies:
      • U.S.: Leads with 700+ patents, emphasizing smart monitoring systems and material innovations[10][16].
      • Europe: Prioritizes eco-friendly designs and extended patent lifespans (e.g., Mithra’s NEXTSTELLIS® protected until 2036)[8][14].
  3. Regulatory Hurdles

    • The European Patent Office (EPO) restricts patents for “private use” contraceptives, complicating claims for vaginal or cervical applications[14].
    • Orange Book listings: Critical for U.S. market exclusivity (e.g., NOMAC-E2’s composition patent listed in 2023)[8][14].

Future Trends

Factor Impact
OTC expansion Opill’s approval (2023) may spur similar non-prescription launches globally[9][13].
Non-hormonal options 250+ patents target barrier devices and natural materials[10].
Digital integration Sensors in implants/rings for real-time hormone tracking gain traction[10].
Market consolidation Acquisitions (e.g., Marksans Pharma-Teva) aim to scale production[9].

Challenges

  • Pricing pressures: Brand-name oral contraceptives saw 90% price hikes from 2011–2014 despite generic competition[19].
  • Patent cliffs: Expiring patents (e.g., Bayer’s Yasmin®) open opportunities for generics but reduce R&D incentives[16][18].

“The integration of estetrol in NEXTSTELLIS® represents a paradigm shift, offering a natural estrogen alternative with fewer side effects.” – Mithra Pharmaceuticals[8].

This landscape underscores a balance between innovation-driven growth and regulatory complexities, with patient accessibility and patent durability remaining central challenges.

References

  1. https://patents.google.com/patent/US6214815B1/en
  2. https://www.fortunebusinessinsights.com/industry-reports/contraceptive-drugs-market-100063
  3. https://www.pharmacompass.com/chemistry-chemical-name/noresthisterone
  4. https://pubchem.ncbi.nlm.nih.gov/patent/US7858605
  5. https://patents.google.com/patent/US7615545B2/en
  6. https://www.growthplusreports.com/report/oral-contraceptive-pills-market/8337
  7. https://www.ncbi.nlm.nih.gov/mesh?Db=mesh&Cmd=DetailsSearch&Term=%22Norethynodrel%22%5BMeSH+Terms%5D
  8. https://www.biospace.com/mithra-s-nextstellis-granted-additional-patent-in-the-united-states
  9. https://www.thebusinessresearchcompany.com/report/oral-contraceptive-pills-global-market-report
  10. https://www.globenewswire.com/news-release/2025/03/07/3039078/0/en/Contraceptive-Devices-Patent-Landscape-Report-2023-2024-2032-Innovations-in-Materials-Smart-Monitoring-and-Eco-friendly-Methods.html
  11. https://pdfs.semanticscholar.org/fd71/96b0b16e8ae69b6c143a3ad759dad1dc82e5.pdf
  12. http://jolt.law.harvard.edu/digest/federal-circuit-finds-bayers-yaz-birth-control-patent-invalid-for-obviousness
  13. https://www.thebusinessresearchcompany.com/report/contraceptives-global-market-report
  14. https://gevers.eu/blog/reproductive-patent-rights-contraception/
  15. https://pmc.ncbi.nlm.nih.gov/articles/PMC11212445/
  16. https://www.ncbi.nlm.nih.gov/books/NBK235205/
  17. https://www.pharmafocuseurope.com/articles/drug-patents-shape-pharma-competition
  18. https://pmc.ncbi.nlm.nih.gov/articles/PMC3702550/
  19. https://pubmed.ncbi.nlm.nih.gov/32525965/
Last updated: 2025-03-23

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