Progestin Drug Class List

Drugs in Drug Class: Progestin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-002	Dec 28, 2006		DISCN	Yes	No
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	AB	RX	Yes	Yes
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005		RX	Yes	Yes
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-001	Feb 29, 2012		RX	Yes	No			Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes

Progestin Market Analysis and Financial Projection

The progestin market is experiencing dynamic growth fueled by evolving therapeutic applications, patent-driven innovation, and shifting regulatory landscapes. This analysis examines key market drivers, therapeutic advancements, and intellectual property developments shaping this critical pharmaceutical sector.

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Market Dynamics and Growth Drivers

• Explosive Market Expansion: The global progestin market is projected to grow from $1.34B (2023) to $2.34B by 2031 at a 12% CAGR[1][17], while progesterone specifically is forecast to reach $3.15B by 2030 with a 13.5% CAGR[10]. This growth is driven by:
  • Rising prevalence of hormonal disorders (PCOS, endometriosis) affecting 10% of reproductive-aged women globally[7]
  • Increased contraceptive adoption, particularly progestin-only pills and long-acting injectables[1]
  • Expanding HRT demand from 1.9B women entering menopause worldwide by 2030[1][14]

Therapeutic Application Breakdown	Application	Market Share (2023)	Growth Driver
Contraception	42%	83% efficacy of progestin-only contraceptives[1]
Menopause Management	28%	74% HRT adoption rate in developed markets[14]
Fertility Treatments	19%	65% ART clinics using progesterone support[7]

• Innovation Frontiers:
  1. Delivery Systems: Transdermal patches (Agile Therapeutics' 2032-patented design[5]) and vaginal rings showing 32% better compliance than oral forms[17]
  2. Formulation Advances: Ultra-micronized progesterone with 40% higher bioavailability[8]
  3. Sustainability Shift: 68% of API manufacturers adopting green chemistry principles[1]

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Patent Landscape Analysis

Key Patent Developments

1. Synthetic Progestogens: Laboratorios Leon Farma's US11439598B2 covers novel synthetic progestins with enhanced receptor binding[2][12]
2. Formulation IP: US10052386B2 protects ultra-micronized progesterone in lipid-based carriers[8]
3. Delivery Innovations: Agile Therapeutics' transdermal patch patent (expiring 2032) demonstrates 92-hour sustained release[5]

Patent Challenge Trends

• 55% of new drugs face patent challenges within first year[6]
• Market size correlates with litigation risk:

  "Drugs generating >$500M annual sales have 83% challenge likelihood vs 22% for <$100M markets" [6]

Case Study: Teva v. Lupin (2012)
Invalidated extended-cycle contraceptive patent (US7,320,969) through prior art demonstrating tricycling regimens were common practice[9]. This highlights:

• Criticality of clinical practice documentation in patent prosecution
• Risks of obviousness challenges for incremental dosing changes

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Regulatory and Economic Pressures

• API Cost Surge: North American progesterone API prices rising 18% in March 2025 due to:
  • 70% supply dependence on China/India[4]
  • New U.S. tariffs increasing import costs by 12-15%[4]
• Patent Quality Scrutiny: FDA Orange Book reforms require 42% more patent substantiation for listing[6]

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Future Outlook

1. Pipeline Innovation: 32 PR-targeted molecules in development, including dual-action contraceptives with CVD benefits[11][15]
2. Personalized Medicine: GenAI-driven formulations projected to capture 25% market share by 2028[16]
3. Biosimilar Impact: 14 key patents expiring 2025-2028, opening $780M generic opportunity[3][18]

The market's trajectory hinges on balancing IP protection with affordable access, particularly as 47% of current revenue comes from patented products[6][18]. With strategic R&D focusing on depot injections and tissue-selective agents, progestins remain central to women's health innovation.

"Investment in progesterone R&D isn't just about market share - it's about rewriting the standard of care for half the world's population." - Market Research Intellect[1]

References

1. https://www.marketresearchintellect.com/blog/progestin-market-on-the-rise-breakthroughs-in-hormonal-therapies-fuel-global-demand/
2. https://pubchem.ncbi.nlm.nih.gov/patent/US11439598
3. https://www.insights10.com/report/us-progesterone-market-analysis/
4. https://www.chemanalyst.com/NewsAndDeals/NewsDetails/experts-predict-north-american-progesterone-api-prices-to-rise-in-march-2025-35354
5. https://ir.agiletherapeutics.com/news-releases/news-release-details/agile-therapeutics-announces-issuance-patent-progestin-patch
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC11867330/
7. https://www.gminsights.com/industry-analysis/progesterone-market
8. https://patents.google.com/patent/US10052386B2/en
9. https://www.robinskaplan.com/newsroom/insights/teva-womens-health-inc-v-lupin-ltd
10. https://www.360iresearch.com/library/intelligence/progesterone
11. https://www.pharmaceutical-technology.com/data-insights/progesterone-receptor-drugs-in-development/
12. https://pmc.ncbi.nlm.nih.gov/articles/PMC7287572/
13. https://www.robinskaplan.com/newsroom/insights/janssen-pharm-inc-v-watson-labs-inc
14. https://www.marketresearch.com/VPA-Research-v4245/Progesterone-Size-Share-Outlook-Product-40321085/
15. https://www.businesswire.com/news/home/20220729005369/en/Progesterone-Receptor-PR-Antagonist-Pipeline-Research-Report-2022---ResearchAndMarkets.com
16. https://www.axinn.com/en/insights/axinn-viewpoints/wipo-publishes-patent-landscape-report-on-genai
17. https://www.theinsightpartners.com/reports/progestin-market
18. https://synapse.patsnap.com/blog/pharmaceutical-insights-norelgestromins-randd-progress
19. https://www.nber.org/system/files/working_papers/w20492/revisions/w20492.rev0.pdf