Physiological Effect: Decreased Sperm Motility

Drugs with Physiological Effect: Decreased Sperm Motility

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Coopersurgical	PARAGARD T 380A	copper	SYSTEM;INTRAUTERINE	018680-001	Nov 15, 1984		RX	Yes	Yes

Decreased Sperm Motility Market Analysis and Financial Projection

The market and patent landscape for drugs affecting sperm motility reveals dynamic developments in both fertility treatments and male contraception. While some compounds aim to improve motility for infertility, others intentionally suppress it for contraceptive purposes, creating parallel innovation tracks with distinct commercial potentials.

Market Dynamics

1. Growth Projections
   The male infertility market is projected to reach $4.74 billion by 2030, growing at a CAGR of 3.54%[11]. Medications targeting sperm quality account for a significant share, driven by hormonal therapies (e.g., gonadotropins) and supplements like zinc-selenium formulations[2][11].

2. Contraceptive Innovation Surge
   Non-hormonal male contraceptives dominate recent R&D efforts:

   • ADAM Hydrogel: Contraline’s injectable hydrogel reduced motile sperm by 99.8–100% in trials, positioning it as a reversible alternative to vasectomy[10][13].
   • EP055 (Eppin Pharma): Binds sperm-surface EPPIN protein, immobilizing sperm in primates with full reversibility[15][18].
   • sAC Inhibitors (Weill Cornell): On-demand oral drugs like TDI-11861 halt sperm motility within 30 minutes, achieving 100% efficacy in mice[16].

3. Segment Competition

   • Assisted Reproductive Technologies (ART): Hold ~55% market share due to high demand for ICSI/IVF[11].
   • Medications: Face challenges from generic drugs but benefit from novel formulations (e.g., antioxidant blends[2]) and repurposed agents like PDE5 inhibitors, which show mixed motility effects[4].

Patent Landscape

1. Non-Hormonal Dominance
   Recent patents prioritize non-systemic approaches:

   • Electrical Stimulation: Low-current scrotal devices boost sperm count via charged particle alignment[6].
   • Biomaterials: ADAM’s hydrogel patent (WO2022073143A1) highlights biocompatible polymer use for sperm blockade[10][13].
   • Targeted Small Molecules: EP055 (targeting EPPIN[15][18]) and sAC inhibitors (blocking cAMP production[16]) exemplify precision mechanisms.

2. Hormonal and Dual-Action Legacy Patents
   Older patents like US4210644A (testosterone-estradiol implants[3]) persist but face declining interest due to side-effect profiles. Dual-action compounds (e.g., adjudin derivatives) remain niche due to toxicity concerns[17].

3. Broad Therapeutic Claims
   Patents often span multiple applications. For example, CN102846673B covers motility-enhancing zinc-selenium supplements for infertility[2], while EP2872212A1’s electrical method claims both fertility improvement and contraceptive effects[6].

Competitive and Regulatory Trends

• Startups Lead Contraceptive Innovation: Contraline and Eppin Pharma are advancing Phase I/II trials, while Big Pharma remains cautious[10][13][18].
• Side-Effect Repurposing: Drugs like sulfamethoxazole (spermotoxicity[5][12]) and SSRIs (motility reduction[5][9]) are studied for contraceptive potential despite original indications.
• Regulatory Hurdles: Reversibility and long-term safety data are critical for contraceptive approvals, as seen in ADAM’s ongoing monitoring[13].

Emerging Opportunities

• On-Demand Contraceptives: sAC inhibitors’ rapid action (<1 hour) could capture a $1.2 billion niche by 2030[16].
• Gene Therapy Synergies: Research into epididymal protease inhibitors (e.g., EPPIN) may enable combined pharmacological/genetic approaches[18].

Key Challenges

• Reversibility Proof: 10–20% of gamendazole-treated animals failed to regain fertility, underscoring preclinical hurdles[17].
• Consumer Perception: Only 34% of men in surveys express willingness to use novel contraceptives, necessitating awareness campaigns[10][16].

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Blockquote Highlight

"ADAM showcased a 99.8-100% reduction in motile sperm... comparable to vasectomy, the most effective contraceptive"[10][13].

Key Takeaway: The convergence of biomaterials, targeted pharmacology, and consumer-focused design is reshaping male reproductive health markets, with non-hormonal contraceptives poised to capture ~30% of the sector by 2030.

References

1. https://www.urotoday.com/recent-abstracts/men-s-health/male-infertility/68311-male-fertility-and-the-effects-of-dermatological-mediations-beyond-the-abstract-by-mona-malakouti-ms-jillian-wong-millsop-md-and-jenny-murase-md.html
2. https://patents.google.com/patent/CN102846673B/en
3. https://patents.google.com/patent/US4210644A/en
4. https://pmc.ncbi.nlm.nih.gov/articles/PMC8100009/
5. https://www.maleinfertilityguide.com/medications-and-supplements
6. https://patents.google.com/patent/EP2872212A1/en
7. https://patents.justia.com/patent/10912762
8. https://www.frontiersin.org/journals/cell-and-developmental-biology/articles/10.3389/fcell.2023.1258574/full
9. https://academic.oup.com/humupd/article/26/6/961/5879883
10. https://www.contraline.com/news/c4ovrhbcostzz18u299no44/
11. https://www.mordorintelligence.com/industry-reports/male-infertility-market
12. https://pmc.ncbi.nlm.nih.gov/articles/PMC5354694/
13. https://www.contraline.com/news/
14. https://cen.acs.org/pharmaceuticals/drug-development/Birth-control-men-male-contraception/100/i41
15. https://synapse.patsnap.com/organization/7bf1ac101feb3ab22836ae7d14fd2c42
16. https://news.weill.cornell.edu/news/2023/02/on-demand-male-contraceptive-shows-promise-in-preclinical-study
17. https://www.frontiersin.org/journals/cell-and-developmental-biology/articles/10.3389/fcell.2020.00061/full
18. https://innovate.unc.edu/birth-control-pill-for-men-how-a-unc-scientist-turned-entrepreneur-plans-to-curb-unintended-pregnancies/