Drugs in MeSH Category Contraceptives, Postcoital, Synthetic

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	12,097,210
Genbiopro	MIFEPRISTONE	mifepristone	TABLET;ORAL	091178-001	Apr 11, 2019	AB	RX	No	No
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,495,650
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	11,969,435
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,500,216
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,780,097
Teva Pharms Usa Inc	MIFEPRISTONE	mifepristone	TABLET;ORAL	211436-001	Aug 3, 2020	AB	RX	No	No

Contraceptives, Postcoital, Synthetic Market Analysis and Financial Projection

The market for synthetic postcoital contraceptives—primarily emergency contraceptive pills (ECPs) like levonorgestrel and ulipristal acetate—has experienced transformative growth, driven by evolving consumer preferences, regulatory shifts, and pharmaceutical innovation. Below is an analysis of the market dynamics and patent landscape shaping this sector.

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Market Growth and Trends

• Expanding Demand: Global ECP sales surged from 8.9 million units in 2012 to 37.6 million units in 2022 in low- and middle-income countries (LMICs), reflecting a 15.7% annual growth rate[1]. By 2033, the global ECP market is projected to reach $826.5 million, up from $606.4 million in 2024, at a CAGR of 3.33%[17].
• Hormonal Contraceptive Market: The broader hormonal contraceptive market, valued at $17.94 billion in 2024, is expected to grow to $31.60 billion by 2034[5], with combination pills (estrogen-progestin) dominating due to their dual role in pregnancy prevention and menstrual health management[16].
• Regional Dominance:
  • North America leads, driven by robust healthcare infrastructure and high awareness. The U.S. emergency contraceptive market alone hit $3.4 billion in 2022, growing at 5.24% CAGR[19].
  • Southeast U.S. saw a 28.6% market share in 2022 due to abortion restrictions, while the Midwest is the fastest-growing region[19].

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Key Market Drivers

1. Rising Unintended Pregnancies: Increased use of ECPs correlates with demand for accessible, non-prescription options post-unprotected intercourse or contraceptive failure[17].
2. Non-Hormonal Innovations: Ulipristal acetate (e.g., ella®), a progesterone receptor blocker, is gaining traction for its higher efficacy and fewer side effects compared to levonorgestrel[4][17].
3. Policy Support: Government and NGO initiatives promote ECP accessibility, particularly in LMICs[1][7].
4. Consumer Preferences: Demand for female-controlled, discreet methods (e.g., vaginal gels like Phexxi®) and "on-demand" options tailored for infrequent sexual activity[7][8].

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Patent Landscape

Leading Innovations

Company/Product	Patent Focus	Key Details
Lupin	Vaginal delivery system	Ultra-low-dose ethinyl estradiol/etonogestrel implant (US20230404911A1)[2]
Evofem (Phexxi®)	Hormone-free gel	Fifth U.S. patent (No. 11,992,472) covers composition and methods[8]
Mithra Pharmaceuticals	Estetrol (E4) synthesis	Australian patents for E4 as emergency contraceptive (expiring 2032)[11]
Ulipristal Acetate	Formulation patents	Multiple patents expiring between 2028–2030 (e.g., US 9,844,510)[4]

Strategic Trends

• Delivery Systems: Novel methods like nasal/pulmonary levonorgestrel administration (US20120263784A1)[14] and long-acting vaginal implants aim to improve compliance[2].
• Extended Protection: Companies prioritize "composition of matter" claims (e.g., Phexxi’s lactic acid-citric acid formulation[8]) and region-specific filings (e.g., Mithra’s Australia focus[11]).
• Regulatory Hurdles: The European Patent Office (EPO) restricts patents lacking industrial applicability, though workarounds exist (e.g., EP2566490 covering "reduction of pregnancy incidence")[18].

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Challenges and Opportunities

• Patent Cliffs: Ulipristal acetate’s key patents expire by 2030[4], opening doors for generics but threatening incumbent revenue.
• Safety and Access: Balancing efficacy with side effects (e.g., thromboembolic risks with estrogen)[16] and addressing disparities in LMIC access[1].
• AI and R&D: Machine learning accelerates drug discovery, enabling targeted therapies like non-peptide GnRH antagonists[12][13].

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Future Outlook

• Personalized Medicine: Tailored formulations based on genetic or metabolic profiles[16].
• Non-Hormonal Expansion: Research into luteolytic agents and immunocontraceptives[3][12].
• Geographic Expansion: Asia-Pacific and Africa are untapped markets with rising healthcare investment[5][17].

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The synthetic postcoital contraceptive market is poised for sustained growth, fueled by innovation in drug delivery and regulatory-tailored patent strategies. However, balancing accessibility, safety, and intellectual property rights remains critical for long-term success.

References

1. https://www.dktinternational.org/wp-content/uploads/2023/08/DKT-ECEC-White-Paper-Final-Digital-081723-1-1.pdf
2. https://www.pharmaceutical-technology.com/data-insights/lupin-files-patent-for-ultra-low-dose-drug-delivery-system-for-contraception/
3. https://pubchem.ncbi.nlm.nih.gov/compound/Anordrin
4. https://www.drugs.com/availability/generic-ella.html
5. https://www.precedenceresearch.com/contraceptive-drugs-market
6. https://d2v96fxpocvxx.cloudfront.net/58770459-5a06-4076-a747-5b73e24cd7c0/documents/AbstractBook_ESGE28thAnnualCongress.pdf
7. https://media.psi.org/wp-content/uploads/2024/07/31103016/Modeling-the-potential-market-size-for-an-ODP-contraceptive-pill.pdf
8. https://www.prnewswire.com/news-releases/evofem-announces-issuance-of-new-us-patent-covering-phexxi-composition-of-matter-302168967.html
9. https://fvvo.eu/assets/781/Abstract_Publication_ESGE28thAnnualCongress_2019_Thessaloniki_2019_Final.pdf
10. https://ceur-ws.org/Vol-2032/om2017_Tpaper4.pdf
11. https://www.biospace.com/mithra-pharmaceuticals-strengthens-e4-patent-position-in-australian-market
12. https://www.ncbi.nlm.nih.gov/books/NBK232760/
13. https://pubmed.ncbi.nlm.nih.gov/38481536/
14. https://patents.google.com/patent/US20120263784A1/en
15. https://www.science.gov/topicpages/u/uas+surrogate+research
16. https://www.globenewswire.com/news-release/2024/11/19/2983428/0/en/Hormonal-Contraceptive-Market-Projected-to-Reach-26-7-Billion-by-2032-Growing-at-4-4-CAGR-Introspective-Market-Research.html
17. https://www.imarcgroup.com/emergency-contraceptive-pills-market
18. https://gevers.eu/blog/reproductive-patent-rights-contraception/
19. https://www.grandviewresearch.com/industry-analysis/us-emergency-contraceptive-pills-market-report