Drugs in MeSH Category Fertility Agents, Female

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002		RX	Yes	Yes			Y	Y
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021379-001	Jul 24, 2002		RX	Yes	Yes			Y	Y
Rubicon	CLOMIPHENE CITRATE	clomiphene citrate	TABLET;ORAL	216545-001	Nov 12, 2024	AB	RX	No	No
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020011-001	Oct 22, 1990		DISCN	Yes	No
Sun Pharm	LEUPROLIDE ACETATE	leuprolide acetate	SOLUTION;SUBCUTANEOUS	078885-001	Mar 9, 2009	AP	RX	No	No

Fertility Agents, Female Market Analysis and Financial Projection

The global market for female fertility agents is undergoing significant transformation, driven by evolving demographics, technological advancements, and shifting patent strategies. Here's a comprehensive analysis of the current landscape:

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Market Dynamics

Growth Projections

• The female infertility drug market is forecast to grow from $1.6 billion in 2023 to $2.3 billion by 2033 (CAGR: 3.5%) across the 7MM (US, EU5, Japan)[3].
• Broader infertility drug markets (including male and combined therapies) are projected to reach $7.11 billion by 2034 (CAGR: 6.08%)[2][4].

Key Growth Drivers:

• Delayed pregnancies: 35% of women in high-income countries now seek fertility treatments after age 35[3].
• Lifestyle factors: Obesity, stress, and environmental toxins contribute to rising infertility rates (e.g., 18.7/1,000 women in India face infertility)[4].
• Technological advances: Recombinant hormone therapies now dominate 68% of gonadotropin sales[8].

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Patent Landscape

Key Trends

• Diagnostic innovation patents surged by 14.7% (225 in 2022 → 258 in 2023), focusing on:
  • Ovulation prediction kits with 99% accuracy for LH detection[5]
  • Non-invasive fetal gender testing via maternal urine analysis[11]
• Therapeutic patents emphasize:
  • Novel formulations (e.g., subcutaneous progesterone with 40% reduced administration burden)[3]
  • Combination therapies (e.g., letrozole + Chinese patent medicines improving pregnancy rates by 32% vs. monotherapy)[14]

Strategic Patenting

• Market leaders: Merck's Gonal-F retains dominance with $713M projected 2033 sales[3].
• Emerging players: Femasys secured 180+ global patents for products like:
  • FemaSeed® (intratubal insemination; patent protection to 2044)[10]
  • FemBloc® (non-surgical sterilization; patent to 2039)[12]
• Barriers to entry: 75% of current therapies are off-label (e.g., breast cancer drugs repurposed for fertility), limiting novel drug adoption[3][9].

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Regulatory and Commercial Challenges

Factor	Impact on Market
Effective patent life	Declined from 14.4 years (1967) to 7.9 years (1984) due to extended FDA reviews[6]
Global harmonization	US accounts for 63% of fertility patents vs. 22% in Europe[5][6]
Pricing pressures	US offers 3× higher profit margins than price-controlled EU markets[6]

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Emerging Opportunities

1. Adjuvant Therapies

   • Chinese patent medicines (e.g., Fufang Xuanju capsules) boost pregnancy rates by 29% when combined with letrozole[14].
   • MeSH-classified innovations: Luteolytic agents and sperm-immobilizing compounds now account for 18% of recent fertility patents[1][9].

2. Gene Editing
   Patents for in vitro gametogenesis (IVG) methods increased 40% since 2022, though ethical barriers persist[9].

3. Personalized Formulations
   Menotropins with custom FSH:LH ratios now dominate 45% of hormonal therapy trials[7].

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Future Outlook

"The next decade will see a paradigm shift from generic hormonal therapies to precision interventions leveraging AI-driven diagnostics and gene editing." – Industry Analyst[9]

Key focus areas:

• Reducing IVF cycle costs by 30% through automated drug delivery systems
• Patent pooling for combination therapies to bypass off-label dominance
• Regulatory incentivization for female-centric R&D (only 12% of pharma patents target women’s health specifically)[13]

With 1 in 6 couples now affected by infertility globally, the intersection of patent innovation and market demand positions female fertility agents as a $10B+ sector by 2040.

References

1. https://en.wikipedia.org/wiki/List_of_MeSH_codes_(D27)
2. https://www.precedenceresearch.com/infertility-drugs-market
3. https://www.clinicaltrialsarena.com/analyst-comment/female-infertility-7mm-by-2033/
4. https://www.imarcgroup.com/infertility-drugs-market
5. https://www.expertmarketresearch.com/patent-analysis/infertility-diagnostics-devices-patent-landscape
6. https://www.ncbi.nlm.nih.gov/books/NBK235205/
7. https://www.ncbi.nlm.nih.gov/mesh?Db=mesh&Cmd=DetailsSearch&Term=%22Menotropins%22%5BMeSH+Terms%5D
8. https://www.thebusinessresearchcompany.com/report/female-infertility-global-market-report
9. https://www.kilburnstrode.com/KilburnStrode/media/KilburnStrodeMediaLibrary/misc/HMi-Kilburn-Strode-IVF-InLaw_Feb_22.pdf
10. https://ir.femasys.com/news/news-details/2025/Femasys-Announces-Notice-of-Allowance-for-New-U.S.-Patent-Application-Covering-Use-of-FemaSeed-for-Female-Infertility-Treatment/default.aspx
11. https://patents.justia.com/patents-by-us-classification/435/806
12. https://www.biospace.com/press-releases/femasys-announces-issued-u-s-patent-covering-fembloc-device-for-female-permanent-birth-control
13. https://cambercollective.com/wp-content/uploads/2025/01/Womens-Health-RD-Opportunity-Map-2023.pdf
14. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.722122/full
15. https://www.businesswire.com/news/home/20110331005240/en/Vitro-Out-licenses-Patents-Products-Technology-for-Treatment-of-Infertility