Drugs in MeSH Category Contraceptive Agents, Female

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hong Kong	MEDROXYPROGESTERONE ACETATE	medroxyprogesterone acetate	INJECTABLE;INJECTION	076553-001	Jul 28, 2004	AB	RX	No	No
Pfizer	DEPO-SUBQ PROVERA 104	medroxyprogesterone acetate	INJECTABLE;SUBCUTANEOUS	021583-001	Dec 17, 2004		RX	Yes	Yes
Duramed Pharms Barr	MEDROXYPROGESTERONE ACETATE	medroxyprogesterone acetate	TABLET;ORAL	040311-003	Dec 1, 1999		DISCN	No	No
Fdn Consumer	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	200670-001	Jul 12, 2012		DISCN	No	No
Fdn Consumer	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	078665-001	Aug 28, 2009		DISCN	No	No
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes			Y
Duramed Pharms Barr	MEDROXYPROGESTERONE ACETATE	medroxyprogesterone acetate	TABLET;ORAL	040311-001	Dec 1, 1999		DISCN	No	No

Contraceptive Agents, Female Market Analysis and Financial Projection

The female contraceptive market is characterized by stable growth and evolving innovation, shaped by demographic trends, regulatory frameworks, and strategic patent activity. Here's an analysis of the current dynamics:

---

Market Overview

• Current Valuation: The 7MM (US, France, Germany, Italy, Spain, UK, Japan) female contraceptive market was valued at $7.8 billion in 2022, projected to reach $8.2 billion by 2032 at a CAGR of 0.5%[1][7][10].
• Regional Trends:
  • US Dominance: Holds 74.6% market share (2022), driven by innovations like Phexxi vaginal gel[1][10].
  • EU Contraction: France, Germany, Italy, and Spain face declining sales due to shrinking female populations[1][7].
  • Japan’s Challenges: Lowest market share (1% in 2022) due to cultural attitudes and population decline[1][7].

---

Key Product Segments

• Dominant Classes:
  • Oral contraceptives (e.g., norgestimate/estradiol combinations)[3][6].
  • Hormonal IUDs (e.g., Mirena, Skyla) and vaginal rings[1][3].
• Growth Drivers:
  • Long-Acting Reversible Contraceptives (LARCs): Rising adoption of IUDs and implants for compliance and efficacy[1][5].
  • Non-Hormonal Alternatives: Innovations like Femasys’ FemBloc® (non-surgical permanent birth control) and Phexxi[4][9].

---

Patent Landscape

• Innovation Focus:
  • Extended-Cycle Regimens: Patents for ascending-dose oral contraceptives (Teva) aimed at reducing side effects[2][8].
  • Smart Devices: Integration of sensors for hormonal tracking (Conceptus Inc.)[9].
  • Eco-Friendly Methods: Biodegradable materials and non-hormonal solutions (Bayer, Alza Corp)[9].
• Key Players:
  • Teva Women’s Health: Holds patents for extended-cycle regimens[2][8].
  • Femasys: Expanded EU patent coverage for FemBloc®, targeting non-surgical sterilization[4].
  • Bayer: Leading in hormonal IUDs (Mirena) and transdermal patches[3][9].

---

Regulatory and Pipeline Insights

• FDA Approval Process:
  • Average 19-month review period for oral contraceptives, with NDAs requiring extensive data (e.g., NORPLANT® implant submission totaled 53 volumes)[11].
  • Patent Life Challenges: Effective patent life shortened due to prolonged approval timelines, impacting profitability[11][14].
• Pipeline Trends:
  • Repurposed Drugs: 66% of candidates are repurposed therapies, prioritizing safety over novel mechanisms[12].
  • Late-Stage Candidates: Focus on reducing adverse effects (e.g., subcutaneous implants, low-dose patches)[10][12].

---

Competitive Dynamics

• Market Leaders: Bayer, Pfizer, Merck, and Organon dominate with established oral and IUD products[1][10].
• Strategic Moves:
  • Geographic Expansion: Femasys securing EU patents to preempt commercialization[4].
  • Collaborations: Partnerships for biosimilar development (e.g., Richter and Hikma)[14].
• Challenges:
  • Generic Competition: Post-patent revenue declines (e.g., Forteo’s 23% drop post-expiry)[14].
  • Population Declines: Impacting EU and Japanese markets[1][7].

---

Future Outlook

• Growth Opportunities:
  • Emerging Markets: Asia-Pacific’s focus on non-hormonal contraceptives[9][14].
  • Digital Health Integration: Smart devices for real-time monitoring (e.g., Conceptus Inc.’s sensor-based IUDs)[9].
• Risks: Regulatory delays and cultural resistance in regions like Japan may hinder adoption[1][7].

---

“Expanding our patent protection in Europe ahead of commercial availability brings us closer to advancing Femasys’ mission to deliver essential technologies globally.” – Kathy Lee-Sepsick, CEO of Femasys[4]

---

Key Takeaways:

1. The US remains the growth engine, while Japan and Europe face headwinds.
2. Innovation focuses on compliance (extended regimens) and non-hormonal options.
3. Strategic patent filings and partnerships are critical to sustaining market position.

References

1. https://www.globaldata.com/store/report/female-contraceptives-major-market-analysis/
2. https://patents.justia.com/patents-by-us-classification/514/841
3. https://www.pharmacompass.com/chemistry-chemical-name/e-gen-c
4. https://www.biospace.com/press-releases/femasys-announces-notices-of-intention-to-grant-for-two-new-european-patent-applications-covering-use-of-fembloc-permanent-birth-control
5. https://www.globenewswire.com/news-release/2025/02/12/3024922/28124/en/Hormonal-Contraceptives-Market-Forecast-2025-2030-Revenues-to-Cross-10-18-Billion-in-2030-Driven-by-the-Introduction-of-Novel-and-Effective-Products-by-Several-Leading-Companies.html
6. https://www.businesswire.com/news/home/20210325005402/en/United-States-Female-Contraception-Market-and-Competitive-Landscape-Report-2021---ResearchAndMarkets.com
7. https://www.clinicaltrialsarena.com/analyst-comment/female-contraceptive-sales-7mm/
8. https://patents.google.com/patent/US7615545B2/en
9. https://www.globenewswire.com/news-release/2025/03/07/3039078/28124/en/Contraceptive-Devices-Patent-Landscape-Report-2023-2024-2032-Innovations-in-Materials-Smart-Monitoring-and-Eco-friendly-Methods.html
10. https://www.businesswire.com/news/home/20240117550160/en/Female-Contraceptives-Market-Forecast-to-2032-Analysis-of-Major-Markets-Epidemiology-and-Pipeline-Assessment---Focus-on-United-States-France-Germany-Italy-Spain-the-United-Kingdom-and-Japan---ResearchAndMarkets.com
11. https://www.ncbi.nlm.nih.gov/books/NBK235205/
12. https://www.conceptfoundation.org/wp-content/uploads/2022/01/AIM-pipeline-FINAL-021221.pdf
13. https://meshb-prev.nlm.nih.gov/record/ui?ui=D003279
14. https://www.researchandmarkets.com/reports/4429707/womens-health-market-size-share-and-trends