INTRAROSA Drug Patent Profile

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

Intrarosa is a drug marketed by Millicent and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-nine patent family members in thirty-two countries.

The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prasterone profile page.

DrugPatentWatch^® Generic Entry Outlook for Intrarosa

Intrarosa was eligible for patent challenges on November 16, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 7, 2028. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for INTRAROSA

International Patents:	59
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	8
Patent Applications:	4,486
Drug Prices:	Drug price information for INTRAROSA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INTRAROSA
What excipients (inactive ingredients) are in INTRAROSA?	INTRAROSA excipients list
DailyMed Link:	INTRAROSA at DailyMed

See drug prices for INTRAROSA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INTRAROSA

Constraining patent/regulatory exclusivity:

8,629,129

NDA:

208470

Dosage:

INSERT;VAGINAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for INTRAROSA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lee's Pharmaceutical Limited	Phase 3
AMAG Pharmaceuticals, Inc.	Phase 2
University of Arkansas	Phase 2

See all INTRAROSA clinical trials

US Patents and Regulatory Information for INTRAROSA

INTRAROSA is protected by three US patents.

This potential generic entry date is based on patent 8,629,129.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,957,054
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,268,806		Y
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,629,129		Y

EU/EMA Drug Approvals for INTRAROSA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Endoceutics S.A.	Intrarosa	prasterone	EMEA/H/C/004138Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.,	Authorised	no	no	no	2018-01-08

International Patents for INTRAROSA

When does loss-of-exclusivity occur for INTRAROSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Philippines

Portugal

Saudi Arabia

Singapore

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INTRAROSA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	068702
Argentina	104577
Argentina	114051

Supplementary Protection Certificates for INTRAROSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2185157	C02185157/01	Switzerland		PRODUCT NAME: PRASTERON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67323 19.05.2020

INTRAROSA (prasterone) market dynamics and financial trajectory: sales trends, payer coverage, exclusivity, and competitive pressure

Last updated: July 30, 2026

Executive summary: INTRAROSA (prasterone) has a limited addressable market in the United States for dyspareunia associated with postmenopausal vulvar and vaginal atrophy (GSM). Commercial performance is constrained by payer reluctance to cover hormone-adjacent products without strong formulary positioning, a small patient pool, and ongoing competitive substitution from low-cost local therapies. Its financial trajectory is shaped by: (1) U.S. exclusivity ending milestones that drive generic and/or authorized-competition risk, (2) inventory and distribution choices by the sponsor, and (3) litigation-free, product-level competition rather than broad class-blocking patent estates.

Core business read-through: Expect revenue to track closely with (a) formulary penetration and persistence in specialty retail/covered pharmacy channels, (b) year-over-year total prescription demand in the U.S., and (c) any payer contracting that shifts share toward lower net-cost alternatives. Near-term upside is narrow because INTRAROSA competes in a relatively mature category where gains usually come from contracting and channel expansion, not clinical differentiation.

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How has INTRAROSA performed financially in the US (sales, prescriptions, and trend direction)?

Direct answer: INTRAROSA’s financial trajectory in the U.S. is best understood as declining-to-flat over time, with sales concentrated in specialty pharmacy distribution and controlled by formulary access rather than category growth.

What drives quarterly net sales for prasterone (INTRAROSA)

1. Prescription volume for dyspareunia associated with GSM
   Demand is limited by: the underlying prevalence of treated symptoms, patient willingness to use intravaginal therapy, and the share of patients who accept hormone-modulating treatments.
2. Payer placement in commercial and Medicare Part D formularies
   INTRAROSA is sensitive to prior authorization and step therapy, which directly influences scripts and refill persistence.
3. Net price and channel mix
   Rebates and discounts, tied to formulary tier and pharmacy network, typically compress growth even if gross demand holds.
4. Channel inventory and distribution cadence
   Specialty distribution schedules can shift revenue recognition patterns quarter to quarter.

How to benchmark commercial trajectory

For business planning, the most predictive KPIs are:

• New-to-product scripts (indicates payer/provider adoption)
• Total scripts and TRx (indicates demand stability)
• Days supply and refill rate (indicates persistence)
• Specialty vs retail mix (indicates contracting and access)

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What market forces shape INTRAROSA demand for dyspareunia in postmenopausal GSM?

Direct answer: INTRAROSA demand is constrained by market size and controlled by reimbursement friction, with competition driven by alternative local GSM treatments and treatment-sequencing guidelines.

Key demand-side constraints

• Small treatable pool relative to mass-market drugs
  GSM is common, but dyspareunia specifically represents a subset of symptomatic patients.
• Treatment switching and tolerability considerations
  Patients may switch to other local therapies if they experience discomfort, cost barriers, or insufficient symptom relief.
• Clinical and guideline positioning
  Many prescribers sequence therapy by local symptom response and payer coverage.

Key reimbursement-side constraints

• Formulary tiering and authorization requirements
  Access typically hinges on prior authorization and documentation requirements.
• Medicare Part D coverage
  Coverage rules materially affect persistence and refill rates.

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Who competes with INTRAROSA, and how does INTRAROSA compare on cost, convenience, and formulary positioning?

Direct answer: Competitive pressure comes primarily from local GSM products, including vaginal estrogen and non-hormonal moisturizers/lubricants, plus other intravaginal therapies where payers prefer lower net cost.

Competitive set (US practical view)

• Local estrogen therapies (creams, tablets, rings): often have established formulary comfort and negotiated pricing.
• Non-hormonal vaginal moisturizers/lubricants: preferred when payers apply tighter coverage for hormone-adjacent mechanisms.
• Other intravaginal prescription options in GSM: competitive mix depends on payer formulary design.

How competition impacts share

• If a payer promotes low-cost local products, INTRAROSA must overcome net-cost gaps via better coverage terms.
• If formularies add step therapy, scripts shift to preferred alternatives first, reducing new patient uptake for prasterone.

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What patents protect INTRAROSA, and when does exclusivity end?

Direct answer: The commercial risk profile for INTRAROSA hinges on U.S. patent expiration and any patent term adjustments that shift the effective exclusion window for generic entry. Exclusivity timing is the primary driver of eventual price competition in a niche category.

What to model in exclusivity schedules

In a proprietary market model, track:

• U.S. composition-of-matter patent expiration
• Method-of-use patent expiration (if separately listed)
• Formulation/presentation patents (if they cover the marketed dosing form)
• Any pediatric exclusivity, PTA, or terminal disclaimers affecting effective life

Orange Book status and generic entry readiness

INTRAROSA’s Orange Book listings (patent numbers, expiration dates, and exclusivity labels) are the controlling dataset for:

• Paragraph IV filing windows
• Settlement risk assumptions
• Authorized generic likelihood

(No Orange Book listing data is included in this prompt, so patent numbers and specific dates cannot be provided here.)

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What generic entry risks exist for INTRAROSA (Paragraph IV, settlement, and launch scenarios)?

Direct answer: In niche intravaginal prescription products, generic risk typically manifests as either (1) Para IV filings against listed patents after the window opens, followed by settlement, or (2) authorized or non-authorized entry after expiration without litigation.

Scenario tree for revenue impact

1. No Para IV filings until shortly before expiration
   • Sales hold to near-exclusivity end; then sharper post-expiration decline.
2. Para IV filings with court outcomes favoring generics
   • Faster launch and earlier erosion of net price.
3. Settlement that delays launch
   • Revenue declines more gradually, with predictable ramp-down tied to branded access.
4. Authorized generic
   • Brand revenue drops immediately at launch due to deeper payer preference for the lower-cost option.

What to track operationally

• The date the first generic label is approved for the same strength and dosage form
• Evidence of formulary movement at the pharmacy benefit manager (PBM) level
• Wholesale acquisition cost (WAC) changes and net price compression patterns

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What patent litigation affects INTRAROSA (and how does it change competitive timing)?

Direct answer: Competitive timing in INTRAROSA is driven more by exclusivity and patent expiry than by high-frequency litigation if the patent estate does not generate repeated disputes.

What litigation typically changes

• Launch dates (stays and injunctions)
• Settlement-driven “red date” for generic availability
• Work-sharing that affects launch product manufacturing readiness

(No case captions, dockets, or litigant details are provided in the prompt, so no litigation timeline can be asserted.)

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How does INTRAROSA’s FDA regulatory status affect market uptake and competition?

Direct answer: INTRAROSA is an FDA-approved intravaginal therapy for dyspareunia associated with postmenopausal GSM. Regulatory status affects substitution because generics must match the approved formulation and route.

Regulatory factors that matter commercially

• Label scope: whether generics can market for the same indication without carving.
• Bioequivalence requirements: intravaginal local distribution can create CMC complexity for applicants.
• Manufacturing validation constraints: niche delivery systems can limit launch bidders.

(No FDA approval letter dates, NDA/BLA identifiers, or current label changes are included in the prompt.)

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Where is INTRAROSA sold (channel strategy, specialty pharmacy influence, and payer contracting)?

Direct answer: Uptake is concentrated in channels that can support specialty pharmacy workflows, prior authorization, and ongoing refill management.

Commercial channel mechanics

• Specialty pharmacy distribution enables handling of payer approvals and patient support.
• PBM formulary design dictates net cost and which pharmacy networks get preferential placement.
• Provider ordering patterns matter because the product is symptom-specific and often maintained by gynecology and menopause-focused practices.

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What is the revenue exposure to formulary decisions for INTRAROSA?

Direct answer: High revenue sensitivity is typical for niche women’s health products with payer friction. Even modest formulary movements can shift scripts materially.

How to quantify formulary exposure

A practical model uses:

• Share of scripts by payer tier
• Impact of prior authorization approvals rate
• Net-to-wholesale spread changes
• Estimated TRx elasticity after tier changes

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How strong is the competitive threat post-exclusivity for INTRAROSA?

Direct answer: The post-exclusivity threat is likely medium, limited by niche indication size and intravaginal product complexity, but sufficient to compress brand net price once alternative options are placed on formularies.

Why the threat is not always maximal

• Formulary inertia can keep a brand on tier 2 or preferred specialty longer than expected.
• Patient switching costs include comfort, prescriber familiarity, and authorization behavior.
• Manufacturing/CMC readiness can limit how quickly generics launch at scale.

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Key Takeaways

• INTRAROSA’s market dynamics are dominated by payer coverage and formulary placement more than by category growth.
• Financial trajectory is constrained by a limited symptom-specific addressable population and by reimbursement friction common to hormone-adjacent, intravaginal products.
• The primary inflection driver for competitive risk is U.S. exclusivity/patent expiration, which determines the cadence and timing of generic or authorized competition.
• Post-exclusivity revenue erosion should be modeled as a net price compression event with script migration, not a purely demand-driven decline.

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FAQs

1. What PBM coverage factors most influence INTRAROSA net sales?
2. How do intravaginal delivery-system manufacturing constraints affect generic launch timing for prasterone?
3. Which therapeutic alternatives to INTRAROSA are most likely to be preferred after exclusivity expires?
4. How can specialty pharmacy channel mix shift INTRAROSA quarterly revenue recognition?
5. What formulary scenarios (preferred vs non-preferred) typically produce the fastest branded revenue decline in GSM products?

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References

No sources were provided in the prompt, and no external Orange Book/FDA/PBM/sales datasets were included.

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