MILPROSA Drug Patent Profile

Which patents cover Milprosa, and what generic alternatives are available?

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-nine 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

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
Slovenia	2249757
Poland	2249757
Lithuania	2249757
Taiwan	I549681
Japan	6124411

Supplementary Protection Certificates for MILPROSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	21C1058	France		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - 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	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
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
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

Last updated: April 25, 2026

MILPROSA: Investment Scenario and Fundamentals Analysis

What is MILPROSA and what does the asset cover?

MILPROSA is an investigational pharmaceutical product label used for a milprosa drug candidate. Public, investment-grade fundamentals analysis requires an unambiguous mapping between the brand name MILPROSA and the underlying INN (active pharmaceutical ingredient), route of administration, indication, and regulatory status (trial phase, NDA/BLA submission, or approvals).

No such mapping is provided in the available information in this thread. Without the active ingredient and program details, fundamentals cannot be tied to clinical endpoints, trial comparability, regulatory risk, or enforceable patent coverage.

This prevents a complete and accurate investment scenario analysis under patent-analyst standards (pricing power, exclusivity duration, freedom-to-operate, and probability-adjusted revenue modeling all depend on the exact molecule and jurisdictional filing set).

What is the investment scenario by value chain stage?

A credible scenario build for a branded/clinical asset must anchor on four pillars:

1. Clinical phase and readouts (primary endpoints, comparator strength, effect size, safety profile, and subgroup consistency).
2. Regulatory pathway (standard vs accelerated, orphan status, priority review, agency interactions).
3. Market formation (current standard of care, class maturity, payer position, and uptake headwinds).
4. IP duration and enforceability (composition-of-matter, method, formulation, polymorph/process, pediatric extensions, market exclusivity, and jurisdiction-by-jurisdiction claim strength).

Because MILPROSA’s drug identity and program specifics are not established here, stage-by-stage valuation and probability weighting cannot be performed.

What are the fundamentals that drive valuation for MILPROSA?

For a defensible fundamentals analysis, the asset must have a defined:

• Active ingredient and drug class
• Indication and target patient population size
• Mechanism of action and clinical differentiation vs standard of care
• Market access (pricing benchmarks, reimbursement landscape)
• Regulatory milestone calendar
• Patent estate map (priority date, filing dates, key families, jurisdiction, claim scope, and expected expiry)

No active ingredient, indication, phase, sponsor, or patent family identifiers are provided. That blocks:

• Probability-adjusted peak sales modeling
• IP-based exclusivity window estimation
• Freedom-to-operate risk screening
• Competitive landscape mapping

What does the competitive landscape analysis require, and is it available?

A patent analyst typically benchmarks:

• Direct comparators in the same indication
• Differentiation by efficacy endpoints and safety discontinuation rates
• Class switching incentives (e.g., oral vs injectable, dosing frequency)
• Generic/biologic biosimilar pressure timelines

To do this for MILPROSA, the asset must be tied to a specific INN/indication. That linkage is missing, so no competitive analysis can be produced from this thread without risking misidentification.

What patent and exclusivity levers would be evaluated for MILPROSA?

Investment underwriting depends on confirmable IP facts such as:

• Earliest priority date for composition-of-matter
• Primary patent family(s) and jurisdictions
• Estimated legal expiry by country
• Term adjustments (where applicable)
• Orphan exclusivity or pediatric extension eligibility
• Secondary IP (formulations, methods, salts/polymorphs, processes)
• Litigation status (cited patents, Paragraph IV, opposition, appeals)

Because MILPROSA’s patent families are not identified here and no jurisdictional filings are listed, the analysis cannot be completed.

What is the required investment thesis structure for MILPROSA?

A Bloomberg-style underwriting memo for a biotech/pharma candidate includes:

• Catalyst ladder with dates
• Risk-adjusted probability tree (clinical success, regulatory approval, launch, uptake, and durability)
• Base/bull/bear financial scenario tied to efficacy and adoption assumptions
• IP-driven moat and enforcement posture
• Financing needs and cash runway through key readouts
• Governance and manufacturing readiness risks

MILPROSA’s program facts are not present here, so the memo cannot be constructed without inventing inputs.

---

Key Takeaways

• A complete and accurate investment scenario analysis for MILPROSA cannot be produced from the information available in this thread because the asset’s underlying drug identity, indication, clinical status, and patent estate are not specified.
• Without those anchor facts, it is not possible to evaluate core investment fundamentals: probability-adjusted value, regulatory risk, competitive positioning, or enforceable IP duration.

---

FAQs

1) What is MILPROSA’s active ingredient and therapeutic indication?
Not provided here.

2) What clinical phase is MILPROSA in, and what are its latest readouts?
Not provided here.

3) Is MILPROSA approved or investigational?
Not provided here.

4) What is MILPROSA’s likely exclusivity window based on patents and regulatory protections?
Not provided here.

5) Who are the direct competitors to MILPROSA in the target indication?
Not provided here.

---

References

[1] No citable sources are available from the provided content in this thread.