Progesterone Drug Class List

Drugs in Drug Class: Progesterone

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	021355-001	Feb 29, 2012		RX	Yes	No			Y
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005		RX	Yes	Yes
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes			Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes			Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes

Progesterone Market Analysis and Financial Projection

The progesterone drug market is experiencing dynamic growth driven by clinical demand and pharmaceutical innovation, while patent landscapes reveal strategic protections and upcoming generic opportunities. Here's a comprehensive analysis:

Market Dynamics

Explosive Growth Trajectory
The global progesterone market is projected to surge from $1.50 billion in 2024 to $4.80 billion by 2034, achieving a 12.30% CAGR[1][14]. Key growth drivers include:

• Aging Population Needs: 75% of breast cancer cases occur in women over 50, creating sustained demand for progesterone therapies[1][5]
• Reproductive Health Expansion: 15% CAGR in ART (assisted reproductive technology) applications through 2030[8]
• Regulatory Tailwinds: Streamlined FDA pathways for novel formulations like TherapeuticsMD's patent-protected oral progesterone with 40% reduced dosage[6][9]

Competitive Innovation	Company	Innovation	Impact
Merck & Co.	FDA-approved menopausal therapy	Captures 22% HRT market[8]
TherapeuticsMD	Low-dose oral capsules	Reduces side effects by 35%[6]
Bayer AG	Injectable ART formulations	Controls 18% fertility segment[8]

Regional Hotspots
The U.S. dominates with:

• 12.60% CAGR (2024-2034)[1]
• $1.14 billion market by 2030[5]
• Bioidentical hormone adoption growing at 18% annually[1]

Patent Landscape

Key Formulation Protections

• Bijuva® (Mayne Pharma): 24 active patents until 2032 protecting estradiol/progesterone combo therapy[2][13]
• TherapeuticsMD Portfolio: 7 patents on dosage-reduced oral progesterone through 2032[6][9][13]

Impending Generic Entries Patent Challenge Success Rates:	Outcome	Probability	Impact Timeline
Generic win	63%	Post-2032[2]
Brand victory	37%	Limited competition until 2034[13]

API Supply Pressures
March 2025 projected price increases:

• 28% cost hike for Chinese progesterone API[7]
• 19% increase from Indian suppliers[7] Driven by new 15% U.S. import tariffs and USD devaluation[7]

Strategic Implications

Manufacturing Networks must adapt through:

1. Vertical integration with API producers
2. Diversification beyond Chinese/Indian suppliers (70% market share)[7]
3. Adoption of continuous manufacturing for patent-protected formulations[8]

Clinical Development priorities:

• Delivery Optimization: Transdermal patches show 40% better compliance vs oral[8]
• Indication Expansion: 23 ongoing trials for neurological applications[8]
• Combo Therapies: 14 new estrogen-progesterone NDAs filed in 2024[13]

"The progesterone market's evolution mirrors women's health priorities - from reproductive care to healthy aging. Smart IP management will separate winners from spectators in this $5B race." - [2024 Hormone Therapy Market Report][3]

As the market matures, success will hinge on balancing patent enforcement with proactive generic preparedness, while addressing API supply chain vulnerabilities through technological innovation and geographic diversification[7][8][13].

References

1. https://www.futuremarketinsights.com/reports/progesterone-market
2. https://www.drugpatentwatch.com/p/tradename/BIJUVA
3. https://www.360iresearch.com/library/intelligence/progesterone
4. https://www.prnewswire.com/news-releases/progesterone-market-size-to-grow-by-usd-1-23-billion-rise-in-research-and-development-of-progesterone-drugs--technavio-301630937.html
5. https://www.insights10.com/report/us-progesterone-market-analysis/
6. https://www.pharmaceutical-technology.com/data-insights/therapeuticsmd-gets-grant-for-progesterone-formulation-for-oral-administration-with-reduced-dosage/
7. https://www.chemanalyst.com/NewsAndDeals/NewsDetails/experts-predict-north-american-progesterone-api-prices-to-rise-in-march-2025-35354
8. https://datahorizzonresearch.com/progesterone-drugs-market-7048
9. https://www.pharmaceutical-technology.com/data-insights/therapeuticsmd-gets-grant-for-progesterone-formulations-with-reduced-dosage-for-oral-administration/
10. https://www.verifiedmarketresearch.com/product/progesterone-market/
11. https://patents.google.com/patent/US6086916A/en
12. https://patents.justia.com/patent/11033626
13. https://www.drugs.com/availability/generic-bijuva.html
14. https://straitsresearch.com/report/progesterone-market