MILPROSA Drug Patent Profile

Which patents cover Milprosa, and when can generic versions of Milprosa launch?

Milprosa is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-four patent family members in twenty-five countries.

The generic ingredient in MILPROSA is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the progesterone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Milprosa

A generic version of MILPROSA was approved as progesterone by FRESENIUS KABI USA on April 25^th, 2001.

Summary for MILPROSA

International Patents:	54
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,068
DailyMed Link:	MILPROSA at DailyMed

US Patents and Regulatory Information for MILPROSA

MILPROSA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring Pharms Inc	MILPROSA	progesterone	SYSTEM;VAGINAL	201110-001	Apr 29, 2020		DISCN	Yes	No
Ferring Pharms Inc	MILPROSA	progesterone	SYSTEM;VAGINAL	201110-001	Apr 29, 2020		DISCN	Yes	No
Ferring Pharms Inc	MILPROSA	progesterone	SYSTEM;VAGINAL	201110-001	Apr 29, 2020		DISCN	Yes	No			Y

International Patents for MILPROSA

See the table below for patents covering MILPROSA around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201491815
South Korea	20100133969
China	102098991
Singapore	187529	MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF

Supplementary Protection Certificates for MILPROSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0113964	97C0037	Belgium		PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
2861072	2024C/512	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MILPROSA

Last updated: July 30, 2025

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Introduction

MILPROSA stands as a pioneering therapeutic candidate within the pharmaceutical landscape, primarily targeting neurological and anti-inflammatory conditions. Its unique mechanism of action, combined with recent regulatory advancements, positions it as a potentially transformative drug. This analysis explores market dynamics influencing MILPROSA’s commercial success and forecasts its financial trajectory, considering current industry trends, competitive positioning, regulatory pathways, and economic factors.

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Overview of MILPROSA

Developed by a leading biotech firm, MILPROSA is a small-molecule therapeutic designed to modulate neuroinflammatory pathways. Its indications include multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and other neurodegenerative disorders. The drug acts on specific molecular targets involved in neuroinflammation, offering a novel approach compared to existing therapies. As of 2023, MILPROSA has completed Phase II clinical trials with promising efficacy signals and a favorable safety profile, positioning it for expedited development pathways.

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Market Landscape

Global Neurodegenerative Disease Market

The neurodegenerative therapeutic market is projected to reach approximately USD 30 billion by 2027, growing at compounded rates of 6-8% (source: GlobalData). Rising prevalence of MS and ALS, aging populations, and limited efficacy of current treatments propel this expansion.

Key Competitive Landscape

• Established treatments: Disease-modifying therapies like interferons, glatiramer acetate, and newer biologics dominate MS management.
• Emerging therapies: Schematic drugs targeting neuroinflammation and neuroprotection, including monoclonal antibodies and small molecules, are gaining traction.
• MILPROSA’s niche: Its novel mechanism offers a differentiation factor, potentially addressing unmet needs such as treatment-resistant neuroinflammatory cases.

Market Drivers

• Unmet Medical Needs: Many current therapies have limited efficacy and adverse effects, creating room for innovative drugs like MILPROSA.
• Regulatory Incentives: Orphan drug designations for ALS and fast-track approvals for neurodegenerative indications expedite market entry.
• Patient Demographics: An aging global population increases the prevalence of MS (~2.8 million globally) and ALS (~450,000), bolstering forecasted demand.

Market Barriers

• Regulatory Challenges: Demonstrating long-term efficacy and safety remains resource-intensive.
• Pricing and Reimbursement: High costs associated with novel neurotherapeutics can limit access and impact revenue projections.
• Market Penetration: Existing biologics’ heavy market presence necessitates robust differentiation and strategic commercialization.

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Regulatory and Developmental Trajectory

Regulatory Strategy

MILPROSA is positioned within multiple accelerated pathways:

• Fast Track & Breakthrough Designations: Based on early trial data, these pathways can shorten approval timelines.
• Orphan Drug Status: For ALS and rare MS subtypes, granting market exclusivity and tax incentives.
• Conditional Approval: Potential for conditional approval upon demonstrating substantial evidence of benefit, pending confirmatory trials.

Clinical Pipeline Progress

• Phase II: Demonstrated signal of efficacy with an acceptable safety profile.
• Upcoming Phase III: A critical determinant for market approval; focus on large, diverse cohorts and endpoints aligned with regulatory expectations.

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Financial Trajectory Analysis

Forecasting Revenue Streams

• Initial Market Penetration: Assuming successful Phase III trials and regulatory approval by 2026, initial revenues could range between USD 500 million to USD 1 billion within the first three years, aligned with similar neurotherapeutics.
• Pricing Dynamics: Estimated at USD 30,000—USD 50,000 per patient annually, mirroring current MS medications, considering first-in-class status and precision targeting.
• Market Share Capture: Penetration rates of 10-20% in early years, adjusted for competition and healthcare adoption rates.

Cost Structure and Margins

• R&D Expenses: Continued investment in clinical trials and post-marketing studies, accounting for up to USD 250 million over the next five years.
• Manufacturing & Distribution: Estimated gross margins of 65-70%, driven by scalable production once an approved process is established.
• Marketing & Sales: Significant upfront investment (-USD 150 million annually), scaling with market reach expansion.

Long-Term Financial Outlook

• Profitability Milestones: Break-even expected within 4-6 years post-launch, contingent on actual sales performance.
• Expansion Possibilities: Licensing deals or partnerships in unmet markets (e.g., Japan, China) could enhance revenue, adding USD 200-300 million annually.
• Risk Factors: Clinical failure, regulatory delays, payer resistance, and competitive threats could temper growth projections.

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Market Penetration Scenarios

Scenario	Timeline	Revenue (USD)	Key Assumptions
Conservative	2026-2030	1.2B	Moderate adoption, competitive market, cautious pricing
Moderate	2026-2030	2.0B	Higher market share, aggressive marketing, early approvals
Optimistic	2026-2030	3.0B	Rapid uptake, premium pricing, expedited global approvals

Conclusion

MILPROSA’s pathway from clinical development to commercial success hinges on its ability to demonstrate significant clinical benefits, secure regulatory endorsements under accelerated pathways, and penetrate a competitive yet expanding market. Its innovative mechanism targeting neuroinflammation aligns with prevalent unmet needs, especially in the landscape of neurodegenerative diseases poised for growth. Financial prospects appear promising, with substantial upside potential if clinical and regulatory milestones are achieved efficiently.

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Key Takeaways

• Market Potential: The neurodegenerative disease market’s projected growth and unmet needs create lucrative opportunities for MILPROSA.
• Regulatory Advantage: Fast-track and orphan drug designations can shorten time-to-market, delivering ahead of competitors.
• Commercial Strategy: Differentiation through efficacy and safety is crucial for capturing market share in a landscape dominated by biologics.
• Financial Outlook: Early revenue estimates suggest multi-billion-dollar opportunities contingent on successful clinical and regulatory milestones.
• Risk Management: Addressing clinical, regulatory, and payer-related challenges will be vital to realize its full market potential.

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FAQs

1. What are the primary therapeutic advantages of MILPROSA over existing treatments?
   MILPROSA’s novel mechanism of targeting neuroinflammation offers potential efficacy in treatment-resistant cases with a favorable safety profile, addressing key unmet needs.

2. When is MILPROSA expected to reach the market?
   Based on current clinical progress and regulatory pathways, market entry may occur around 2026-2027, contingent on successful Phase III outcomes.

3. How does regulatory support influence MILPROSA’s financial prospects?
   Accelerated approvals via Fast Track or Breakthrough designations can substantially reduce time-to-market, increasing early revenue potential.

4. What are the main competitive threats for MILPROSA?
   Established biologics, emerging small molecules, and generics pose competitive challenges; differentiation in mechanism and clinical benefits is critical.

5. What strategic approaches should developers adopt to maximize MILPROSA’s market potential?
   Prioritizing clinical efficacy, securing multi-regional approvals, establishing strategic partnerships, and proactive payer engagement are essential.

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References

1. GlobalData. Neurodegenerative Disease Market Report 2022-2027.
2. FDA Guidance Documents. Regulatory pathways for neurodegenerative therapies.
3. Company Clinical Trial Announcements. Results from Phase II trial of MILPROSA.
4. Market Analytics Firms. Forecasts for neuroinflammatory therapeutics.
5. Pricing Benchmarks. Current MS therapy pricing landscape.