FEMLYV Drug Patent Profile

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

Femlyv is a drug marketed by Millicent Mfg Pr and is included in one NDA. There is one patent protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in FEMLYV is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Femlyv

There is one tentative approval for the generic drug (ethinyl estradiol; norethindrone acetate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for FEMLYV

International Patents:	6
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for FEMLYV
What excipients (inactive ingredients) are in FEMLYV?	FEMLYV excipients list
DailyMed Link:	FEMLYV at DailyMed

See drug prices for FEMLYV

US Patents and Regulatory Information for FEMLYV

FEMLYV is protected by one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Millicent Mfg Pr	FEMLYV	ethinyl estradiol; norethindrone acetate	TABLET, ORALLY DISINTEGRATING;ORAL	218718-001	Jul 22, 2024		RX	Yes	Yes			Y
Millicent Mfg Pr	FEMLYV	ethinyl estradiol; norethindrone acetate	TABLET, ORALLY DISINTEGRATING;ORAL	218718-001	Jul 22, 2024		RX	Yes	Yes

International Patents for FEMLYV

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

Country	Patent Number	Title	Estimated Expiration
Australia	2021351921	Orodispersible formulations
Canada	3194494	FORMULATIONS ORODISPERSIBLES (ORODISPERSIBLE FORMULATIONS)
European Patent Office	4221693	FORMULATIONS ORODISPERSIBLES (ORODISPERSIBLE FORMULATIONS)
Japan	2023543953	口腔内分散性配合物

Supplementary Protection Certificates for FEMLYV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629

Last updated: June 28, 2026

MLYV Market Dynamics and Financial Trajectory (Revenue, Pricing, Demand, and Patent-Driven Risk)
Executive summary: FEMLYV market trajectory is driven by (1) its contracted payer access and channel mix, (2) the cadence of formulary uptake as new-to-market immunology/oncology-linked products cycle through managed-care reviews, and (3) the degree of IP and exclusivity protection governing dose-form and indication scope. A complete financial trajectory and market sizing cannot be stated from the available information in this request alone.

What is FEMLYV and what therapeutic class does it belong to?

Featured snippet answer: FEMLYV’s therapeutic class, dosing regimen, and indication coverage determine both demand capture and competitive substitution risk.

Which FDA indication(s) does FEMLYV cover?

• Indication list and strength-specific labeling drive addressable patient pool.
• Indication breadth affects payer depth (tier placement, prior authorization strictness) and uptake velocity.

What dosage forms and strengths are marketed?

• Revenue is split by strength and presentation where contracting differs by NDC.
• Formulation-level IP typically controls biosimilar or generic-entry substitution risk.

How is FEMLYV priced and how do payer rules affect net sales?

Featured snippet answer: Net sales track payer mix. List price is less predictive than formulary access, utilization management, and site-of-care policy.

What are the main drivers of FEMLYV net price?

• Contracted discounts vs. gross-to-net waterfall components (rebates, patient assistance, wholesaler chargebacks).
• Pharmacy benefit vs medical benefit split influences reimbursement rates and administrated demand timing.

How do prior authorization and step therapy affect adoption?

• High-friction utilization management delays initial growth and shifts demand to specialty hubs.
• Loosening criteria typically shows up first in claims-based persistence and share capture.

What is the site-of-care (hospital vs specialty pharmacy) effect?

• Hospital procurement can front-load demand but is budget-constrained by diagnosis-related bundles and pharmacy committees.
• Specialty pharmacy shifts channel economics and improves refill predictability.

What market dynamics are shaping FEMLYV demand growth?

Featured snippet answer: FEMLYV uptake is shaped by competitive standards of care, clinician switching behavior, and formulary committee timelines.

Who are the competitive alternatives for FEMLYV’s labeled use?

• Competitive set depends on mechanism-of-action parity and safety profile overlap.
• Substitution pressure increases when efficacy endpoints overlap and tolerability differences are small.

How do clinical guideline cycles affect sales?

• Guideline updates and specialty society positioning can shift prescribing from “preferred” to “required” products.
• Timing typically lags trial readouts by 1 to 3 guideline cycles or payer committees.

What are key supply chain and manufacturing bottlenecks?

• Specialty injectables and biologics face slower ramp risk if fill-finish or DS/DP scale is constrained.
• Manufacturing disruptions can cause missed coverage windows and lost formulary momentum.

When does FEMLYV peak, and when does growth slow?

Featured snippet answer: Peak sales timing is determined by (1) formulary penetration and (2) competitive entry or label expansion constraints.

What uptake curve signals a peak?

• Rising share with stable discontinuation rates indicates sustained demand.
• Once formulary penetration saturates, growth shifts to patient population growth and persistence.

What factors cause growth to decelerate before exclusivity ends?

• Competitive efficacy updates or new entrants can cap share even under exclusivity.
• Indication narrowing by real-world safety can reduce addressable demand.

What is FEMLYV’s financial trajectory by year?

Featured snippet answer: FEMLYV’s annual revenue trajectory cannot be provided from the current input because no financial dataset, time series, or reporting authority is included.

Revenue trajectory components to model

• Gross-to-net: rebates, discounts, chargebacks, patient assistance.
• Utilization: prescription/infusion volumes, days of therapy, dose intensity.
• Pricing: contract renewals and rebase clauses across Medicare/managed Medicaid.

How should analysts forecast FEMLYV net sales?

• Build a claims-to-revenue bridge: utilization by payer segment multiplied by contracted reimbursement.
• Add competitive share scenarios using formulary tier migration and PA pass-through rates.

How strong is FEMLYV’s patent and exclusivity position, and how does it affect revenue risk?

Featured snippet answer: Exclusivity strength determines how long FEMLYV blocks generic or biosimilar substitution, which directly sets the downside revenue risk profile.

What patents protect FEMLYV (composition, formulation, method-of-use)?

• Composition-of-matter patents typically form the core exclusivity moat.
• Method-of-use patents can block label-based switching even if composition patents expire.
• Formulation patents can delay competitive “design-around” substitutes.

When does FEMLYV lose exclusivity?

• Exclusivity end dates include regulatory data exclusivity and patent expiry, which do not always align.
• Any generic or biosimilar entry risk starts at the earliest statutory trigger.

What generic or biosimilar entry risks exist for FEMLYV?

• Small-molecule vs biologic status changes the entry pathway (ANDA vs BLA/Bs).
• Even if exclusivity expires, label protection can delay substitution if competitors cannot be approved for the same indications.

What is the Orange Book status of FEMLYV?

Featured snippet answer: Orange Book listings define patent numbers tied to each approved drug product and each listed indication.

How many patents are listed for FEMLYV, and what do they cover?

• Count of listings by patent type (composition, method, formulation) impacts litigation probability and settlement leverage.

Which companies have Paragraph IV (or biosimilar) challenges?

• The existence of ANDA Paragraph IV certifications or biosimilar litigation affects timing of settlements and launch risk.
• Challenge count and court outcomes determine likely at-risk launch timing.

What FEMLYV litigation affects launch timing or revenue?

Featured snippet answer: Patent litigation outcomes determine whether a generic/biosimilar can launch at earliest eligibility dates.

What settlements or consent judgments involve FEMLYV?

• Settlement agreements can lock market exclusion beyond statutory expiry via “workshare” or delayed launch covenants.
• Launch “at-risk” vs “post-settlement” determines revenue drawdowns.

What court timelines matter most?

• If an injunction is in force, entry is delayed regardless of exclusivity arithmetic.
• Final appellate timing can extend exposure into future quarters.

How does FEMLYV compare with peer products on competitive and financial metrics?

Featured snippet answer: FEMLYV’s financial trajectory depends on its relative share, payer access speed, and competitive discontinuation risk versus its closest labeled comparators.

Side-by-side comparison framework

• Net sales growth rate vs each competitor.
• Share movement by payer segment.
• Net price and persistence (patients continuing therapy at 3, 6, 12 months).

Key differentiators that move market share

• Efficacy within label, safety tolerability, administration method burden, and dose frequency.
• Real-world outcomes and formulary “preferred” criteria alignment.

Geographic coverage and regional uptake differences for FEMLYV

Featured snippet answer: Regional payer policy differences drive disparate growth and can create second wave revenue after coverage expands.

What markets contribute most to FEMLYV revenue?

• US typically anchors specialty drug revenue; secondary markets depend on EU/UK reimbursement categories.
• Price regulation in certain geographies can compress growth rates even with high clinical adoption.

How do regional formularies change adoption pace?

• Managed entry agreements can slow upfront adoption but stabilize longer-term volume.

Key risks to the FEMLYV revenue forecast

Featured snippet answer: The highest-impact risks are coverage access, competitive substitution timing, and IP invalidation or carve-out settlement outcomes.

Commercial risks

• Formulary rejection or restrictive prior authorization can stall growth.
• Payer re-contracting at lower net prices can depress net sales even if volume rises.

Regulatory and legal risks

• Adverse labeling changes can reduce use.
• Adverse patent outcomes can accelerate substitution.

Operational risks

• Manufacturing shortfalls create supply constraints and lost demand during coverage windows.

Key Takeaways

• FEMLYV’s market dynamics are primarily governed by payer access speed, channel mix, and competitive substitution timing tied to IP and exclusivity.
• A precise financial trajectory (annual revenue, growth rates, net price trends, and forecast ranges) cannot be produced from the information provided in this request.
• The highest decision-grade revenue risks cluster around exclusivity timeline, Orange Book-listed patent scope, and litigation or settlement timing that determines at-risk launch windows.
• Competitive share outcomes should be modeled using formulary penetration and utilization management pass-through rather than list price alone.

FAQs

1. How do formulary tier changes translate into quarterly net sales movement for FEMLYV?
2. What is the earliest plausible generic or biosimilar entry date for FEMLYV based on exclusivity and patent expiry?
3. Which patent categories (composition, method-of-use, formulation) most affect FEMLYV label substitution risk?
4. How does site-of-care (hospital vs specialty pharmacy) change FEMLYV reimbursement economics?
5. What litigation outcomes most influence settlement-driven delay in FEMLYV generic or biosimilar launches?

References

1. APA (No sources were provided in the request; no external citations can be generated without specific FEMLYV regulatory and financial documents.)