EVAMIST Drug Patent Profile

When do Evamist patents expire, and when can generic versions of Evamist launch?

Evamist is a drug marketed by Padagis Us and is included in one NDA.

The generic ingredient in EVAMIST is estradiol. There is one drug master file entry 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 Evamist

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

Summary for EVAMIST

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	4,075
Drug Prices:	Drug price information for EVAMIST
Drug Sales Revenues:	Drug sales revenues for EVAMIST
What excipients (inactive ingredients) are in EVAMIST?	EVAMIST excipients list
DailyMed Link:	EVAMIST at DailyMed

See drug prices for EVAMIST

See drug sales revenues for EVAMIST

Recent Clinical Trials for EVAMIST

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

Sponsor	Phase
Lumara Health, Inc.	Phase 3

See all EVAMIST clinical trials

Pharmacology for EVAMIST

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for EVAMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007		RX	Yes	Yes

Expired US Patents for EVAMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007	6,299,900
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007	6,978,945
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007	6,923,983

International Patents for EVAMIST

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

Country	Patent Number	Title	Estimated Expiration
Austria	324865
Austria	410136
Austria	472997

Supplementary Protection Certificates for EVAMIST

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

EVAMIST (drug market dynamics and financial trajectory): forecastable revenue path, exclusivity drivers, competitive risks, and funding/investment implications

Last updated: July 23, 2026

What is EVAMIST and what market does it serve?

EVAMIST is not identifiable from the provided information set. “Evamist” commonly refers to an estrogen therapy product brand name in the US (historically associated with transdermal/gel and spray formats), but no confirmed drug identity, active ingredient, FDA label indication, NDC, manufacturer, or regulatory pathway is included here. Without the specific EVAMIST definition (active ingredient + dosage form + jurisdiction), a financial trajectory and market-dynamics assessment cannot be completed.

What is EVAMIST’s FDA status and Orange Book listing (and why does it matter)?

A market and exclusivity timeline depends on whether EVAMIST is listed in FDA’s Orange Book (for drug product and patents) and whether it is subject to 5-year new chemical entity (NCE) exclusivity, 3-year new clinical investigation exclusivity, or periods for listed patents tied to specific dosage forms and methods of use. No Orange Book record or FDA submission identifiers are provided, so the exclusivity and generic/biosimilar entry risk cannot be mapped.

How do FDA approval date and exclusivity windows shape EVAMIST revenue?

Revenue inflection points require at least one of:

• NDA approval date and exclusivity start/end
• Orange Book patent expiration dates and scope (drug substance, formulation, method of use)
• Pediatric exclusivity or patent term adjustment affecting effective launch timelines

No such dates are included for EVAMIST.

When does EVAMIST lose exclusivity and what patents likely block generic entry?

Generic entry risk is driven by:

• earliest Orange Book patent expiration
• whether patents are formulation- or method-of-use-scoped
• whether FDA lists patents covering the exact dosage form and strength
• whether Paragraph IV challenges have been filed and settled

EVAMIST-specific patent data is not provided, so it is not possible to produce a credible expiration calendar or strength-of-patent assessment.

What patent estate and formulation IP protect EVAMIST (and how many patents cover it)?

A defensible count of protecting patents requires Orange Book patent listings tied to EVAMIST’s NDA/NDC. Without those listings, patent coverage breadth and likely litigation exposure cannot be quantified.

Which companies control the EVAMIST patent and marketing rights?

A market dynamics profile also requires the identity of:

• NDA holder / marketing authorization holder
• patent assignees on listed patents
• label-holder enforcement patterns and settlement history

No assignees, NDA holder, or patent owners are provided for EVAMIST.

Are there Paragraph IV filings or patent litigations involving EVAMIST?

Market trajectory is sensitive to:

• Paragraph IV notice dates
• district court outcomes
• Federal Circuit affirmances
• settlement entry dates and agreed-upon design-arounds

No EVAMIST litigation docket information is provided.

What does EVAMIST’s competitive landscape look like versus branded and generic alternatives?

A competitive analysis needs:

• drug class and competitors on the same formulary tier
• therapeutic equivalents and close substitutes
• pricing and contracting dynamics (e.g., PBM formularies, Medicare Part D share, GPO penetration)
• channel mix: retail, mail, specialty distribution, institutional sales

EVAMIST’s therapeutic class, competitors, and commercial mix are not provided.

How do pricing, reimbursement, and channel contracting affect EVAMIST revenue?

Revenue drivers typically include:

• Wholesale Acquisition Cost (WAC) changes and net price erosion
• rebates tied to utilization and formulary placement
• acquisition cost inflation or reduction in margin due to generic entry
• payer restrictions and prior authorization patterns

No EVAMIST pricing, rebate, net-to-gross, or payer policy data is supplied.

What is EVAMIST’s historical financial trajectory (revenue, growth, margins)?

A financial trajectory requires at minimum one of:

• company-reported revenue for EVAMIST (segment disclosure or product disclosure)
• audited or estimated IMS/Trends-type sales
• quarterly updates tied to label, volume, price, and competitive entry

No sales figures, revenue estimates, or company financial excerpts are included for EVAMIST.

What near-term and medium-term revenue scenarios are most likely for EVAMIST?

A scenario model for branded drug revenues typically ties:

• forecasted volume based on prescription trends and formulary status
• price trend based on net-to-gross and competitive pricing
• probability-weighted generic entry timing driven by patent calendar
• impact of settlements and authorized generics
• geographic expansion or label expansion events

No EVAMIST calendar, competitive entry triggers, or label expansion events are provided.

How strong is EVAMIST’s commercial position given risk of generic substitution?

Commercial defensibility depends on:

• number of strengths/dosage forms with patent coverage
• whether alternative generics can be substituted without label or formulation changes
• whether method-of-use patents block substitution at the payer decision point
• switching barriers tied to device requirements or patient preference

Without EVAMIST-specific IP and formulation facts, defensibility cannot be assessed.

What manufacturing or supply-chain/IP barriers could affect EVAMIST market share?

If EVAMIST has specialized delivery technology (device, penetration enhancer systems, manufacturing steps), generic applicants may face:

• process patent constraints
• chemistry and manufacturing controls challenges
• regulatory bottlenecks in bioequivalence/quality systems

No EVAMIST manufacturing or CMC constraints are provided.

How does EVAMIST compare with other estrogen therapies or transdermal brands on revenue stability?

Comparison requires:

• active ingredient equivalence and route
• market size and growth rates for the drug class
• competitor pricing and share dynamics
• exclusivity and patent status of adjacent products

No EVAMIST identity (active ingredient + route) is provided, so an apples-to-apples comparison cannot be generated.

What investment and licensing signals does EVAMIST’s trajectory imply?

Investors and licensors rely on:

• product life-cycle stage (launch, peak, plateau, or pre-loss-of-exclusivity)
• pipeline replacement risk (next-gen reformulations or line extensions)
• royalty and milestone structure tied to regulatory and sales milestones
• probability-weighted downside from generic entry and settlement terms

EVAMIST-specific commercial and legal drivers are missing.

---

Key Takeaways

• EVAMIST cannot be mapped to a specific drug identity (active ingredient, dosage form, indication, NDA/NDC, applicant/holder) from the provided information, so its FDA status, exclusivity, patent-expiration calendar, Paragraph IV and litigation risk, and financial trajectory cannot be stated accurately.
• Without EVAMIST’s confirmed Orange Book record, patent listings, and sales data, no credible revenue path or market-dynamics forecast can be produced.

FAQs

1. How can I identify whether “EVAMIST” is listed in the Orange Book under the same NDA/NDC as the marketed product?
2. What Orange Book patent categories (drug substance, formulation, method of use) most strongly delay generic substitution for branded topical/transdermal products?
3. How do Paragraph IV settlements typically structure entry dates and authorized generic launch timing for branded drugs?
4. What revenue metrics best predict branded drug net sales erosion ahead of loss of exclusivity (TRx growth, net-to-gross trend, rebate changes)?
5. Which regulatory and CMC factors most often delay ANDA approvals for complex dosage forms tied to delivery systems?

References

No sources are provided because EVAMIST’s identity and FDA/patent records are not specified.