VAGIFEM Drug Patent Profile

When do Vagifem patents expire, and what generic alternatives are available?

Vagifem is a drug marketed by Novo Nordisk Inc and is included in one NDA.

The generic ingredient in VAGIFEM is estradiol. There are seventy-five drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vagifem

A generic version of VAGIFEM was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for VAGIFEM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	17
Patent Applications:	4,094
Drug Prices:	Drug price information for VAGIFEM
Drug Sales Revenues:	Drug sales revenues for VAGIFEM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VAGIFEM
What excipients (inactive ingredients) are in VAGIFEM?	VAGIFEM excipients list
DailyMed Link:	VAGIFEM at DailyMed

See drug prices for VAGIFEM

See drug sales revenues for VAGIFEM

Recent Clinical Trials for VAGIFEM

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

Sponsor	Phase
University of Washington	Phase 2
Breast Cancer Research Foundation	Phase 2
University of California, Irvine	PHASE4

See all VAGIFEM clinical trials

Pharmacology for VAGIFEM

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Paragraph IV (Patent) Challenges for VAGIFEM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VAGIFEM	Vaginal Tablets	estradiol	10 mcg	020908	1	2013-01-02

US Patents and Regulatory Information for VAGIFEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-002	Nov 25, 2009	AB	RX	Yes	Yes
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-001	Mar 26, 1999		DISCN	Yes	No

Expired US Patents for VAGIFEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-002	Nov 25, 2009	5,860,946
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-002	Nov 25, 2009	7,018,992

International Patents for VAGIFEM

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

Country	Patent Number	Title	Estimated Expiration
Austria	240764
Australia	3254397
Canada	2258310	INSTRUMENT POUR L'INTRODUCTION D'UN SUPPOSITOIRE (INSTRUMENT FOR INSERTING A SUPPOSITORY)
Germany	69722203
European Patent Office	0910427	INSTRUMENT POUR L'INTRODUCTION D'UN SUPPOSITOIRE (INSTRUMENT FOR INSERTING A SUPPOSITORY)
World Intellectual Property Organization (WIPO)	9801180
Austria	532521

Supplementary Protection Certificates for VAGIFEM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	C00136011/03	Switzerland		PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307

Last updated: July 24, 2026

Vagifem (estradiol vaginal tablet) market dynamics and financial trajectory: sales drivers, pricing, exclusivity, and competitive pressure

Vagifem (estradiol vaginal tablets) revenue is shaped by a shrinking eligible-use population for low-dose local estrogen, payer movement toward lower-cost options, and steady uptake of competing local estrogen products and dosing regimens. The long-run sales path depends on the cadence of FDA product lifecycle events (Orange Book exclusivity and patent expirations) and whether payers steer patients to preferred formularies.

What matters commercially

• Local estrogen market is largely payer-led. Brand-to-generic substitution and formulary placement drive unit mix more than clinical differentiation.
• Dose schedule affects adherence and switching. Products with fewer administrations and favorable coverage typically win incremental persistence.
• Regulatory and patent timing drives competitive entry. Paragraph IV filings, settlements, and exclusivity windows determine the pace of price erosion.
• Competition is concentrated in “low-dose vaginal estradiol” niches where wholesalers, payers, and PBMs prioritize acquisition cost.

What is the market size trajectory for Vagifem in the local vaginal estrogen segment?

Vagifem sits in the local estrogen bucket used for genitourinary syndrome of menopause (GSM), including vaginal dryness and related symptoms. This category is characterized by:

• High proportion of covered patients through Medicare and commercial formularies.
• Local administration that limits systemic steroid concerns versus oral estrogen, supporting broad clinician acceptance.
• A fragmented competitive set across tablets, creams, and rings, with products branded and generic.

Segment dynamics that influence the trajectory

• Prevalence expansion: GSM prevalence increases with age, supporting baseline demand.
• Treatment conversion: Many patients treat intermittently, so persistence and refill behavior drive revenue more than initiation.
• Formulary tightening: PBMs increasingly use preferred-product tiers and acquisition-cost-based contracting.

Commercial implication Even with a stable disease-state prevalence, the brand revenue rate can decelerate as:

• generic/local substitutes gain share,
• plan formularies move toward lowest-cost products,
• and dosing convenience shifts prescribing.

How have Vagifem sales been trending financially and what are the key inflection points?

A reliable “financial trajectory” assessment requires consolidated sales reporting for Vagifem in the US and, ideally, major ex-US markets. The dataset for this analysis is not present in the prompt, so a complete, accurate sales timeline with figures cannot be produced.

What competitive products pressure Vagifem pricing and share?

Vagifem’s main competitive pressure comes from other low-dose vaginal estrogen offerings used for GSM. Key competitive dimensions:

• Formulation type: tablet vs cream vs ring (adherence and cost differences).
• Dosing frequency: lower frequency schedules typically improve persistence and can improve formulary status.
• Acquisition cost and rebates: dominant in payer contracting.

Where pressure typically shows up

• Retail and mail mix shifts toward preferred formulary products.
• Wholesaler purchasing patterns move to contract-preferred SKUs.
• Prescriber switching clusters around formulary renewals and pharmacist substitutions.

How do dosing regimen and delivery system changes affect Vagifem demand?

Vagifem’s value proposition is local delivery and established dosing. Sales behavior in local estrogen is strongly tied to:

• Patient ease of use, especially for elderly patients.
• Perceived efficacy within a short onset window.
• Persistence through maintenance phases.

Commercial implication

• If competitors offer comparable symptom relief with a simpler or less frequent regimen, switchers increase and brand refill rates drop.
• Lower copays for preferred products amplify early-cycle switching, which is where brand revenue is most vulnerable.

What patents protect Vagifem and how strong is the patent estate?

Patent protection scope affects generic entry risk and thus long-term pricing. Without the Orange Book listing and specific patent data for Vagifem, a defensible patent-coverage map with expiration dates cannot be completed accurately.

When does Vagifem lose exclusivity and what generic entry risks exist?

Generic entry risk is governed by:

• Orange Book-listed patents and their expiration dates,
• exclusivity categories tied to the NDA,
• and any Paragraph IV litigation/settlement milestones.

The prompt does not include the relevant Orange Book patent and exclusivity table, so an exclusivity timeline and entry-risk assessment cannot be produced without risking factual errors.

What is the Orange Book status of Vagifem?

Orange Book status requires the exact listing of:

• patents by number,
• expiration dates,
• exclusivity codes,
• and whether patents cover drug substance, drug product, or method-of-use.

This listing is not provided, so the Orange Book status cannot be stated.

Have there been Paragraph IV challenges or patent litigation for Vagifem?

A Paragraph IV challenge and any resulting litigation/settlement materially change the commercial trajectory via:

• accelerated generic launch,
• take-away of formulary share,
• and rebate repricing by the brand.

This prompt does not include litigation case names, dockets, or settlement terms, so a legally grounded account cannot be produced.

Does Vagifem face biosimilar-like substitution risks or only generic risks?

Vagifem is a small-molecule estradiol product, not a biologic, so “biosimilar” frameworks do not apply. Market substitution for Vagifem is therefore tied to:

• generic versions (ANDA),
• and therapeutic alternatives (other local estrogen dosage forms).

How do payers and PBMs manage coverage for Vagifem, and what does that mean for revenue?

Coverage for local estrogen products typically reflects:

• tier placement (preferred vs nonpreferred),
• prior authorization requirements for higher-cost brands,
• step therapy protocols within the therapeutic class,
• and contract-driven acquisition cost.

Revenue translation

• If Vagifem is nonpreferred, utilization generally shifts toward lower-cost preferred products.
• If copays are reduced through manufacturer contracting, market share retention improves.
• Changes in Medicare Part D formularies can create periodic utilization swings.

What is the pricing outlook for Vagifem as generics or competitors gain share?

Without documented pricing or gross-to-net components, a forecast cannot be stated precisely. The standard pattern for local estrogen brands after competitor gains:

• list price may hold or adjust modestly,
• but rebates increase and net price declines,
• gross revenue falls faster than units due to contracting and formulary tier shifts.

How does Vagifem compare with key local estrogen rivals on commercial competitiveness?

A defensible comparison requires named rivals, their dosage forms, dosing schedules, and US market availability. The prompt does not include that competitor list, and a generalized comparison risks being factually incomplete.

Which companies market and distribute Vagifem, and how do channel dynamics affect financial results?

A complete channel-and-corporate map requires:

• current NDA holder and manufacturer (labeler information),
• distributor/wholesaler relationships,
• and branded product lifecycle changes.

Those specifics are not included in the prompt.

What regulatory milestones (FDA approvals, labeling changes) could shift Vagifem’s commercial path?

Regulatory milestones that can shift commercial outcomes include:

• label expansion or narrowing for indications,
• dosing schedule changes,
• product discontinuations/relaunches,
• REMS-like requirements (rare for this product class),
• and safety updates.

No FDA milestone list is provided in the prompt, so no accurate timeline can be produced.

What manufacturing and supply constraints could affect Vagifem availability and sales?

Supply constraints can cause:

• wholesaler shortages,
• backorders and lost prescription fulfillment,
• and temporary price spikes that do not always translate to sustained net revenue.

The prompt contains no supply or recall history for Vagifem, so this cannot be addressed with hard data.

Key Takeaways

• Vagifem’s market dynamics are driven primarily by payer formularies, local estrogen competitive alternatives, and dosing/persistence effects.
• The long-run financial trajectory depends on exclusivity and patent/litigation timelines, but those specifics cannot be stated without Orange Book and case data.
• Revenue erosion risk is structurally higher in this segment once preferred formularies shift to lower-cost local estradiol options.
• Accurate financial trajectory and patent/Orange Book assessments require product-specific listing and sales reporting that is not included in the prompt.

FAQs

1. How do Medicare Part D formulary changes typically affect vaginal estrogen brand revenue?
2. What competitive tactics (rebates, copay cards, step edits) are most common in the low-dose vaginal estrogen class?
3. How does dosing frequency influence persistence for local estrogen tablets versus creams or rings?
4. What Orange Book patent types most often delay generic entry for local estrogen products?
5. What indicators show an approaching generic launch in local estrogen markets (NDC activity, tender shifts, utilization drops)?

References

No sources were provided in the prompt.

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