DELFEN Drug Patent Profile

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Which patents cover Delfen, and when can generic versions of Delfen launch?

Delfen is a drug marketed by Personal Prods and is included in one NDA.

The generic ingredient in DELFEN is nonoxynol-9. Additional details are available on the nonoxynol-9 profile page.

Summary for DELFEN

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for DELFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Personal Prods	DELFEN	nonoxynol-9	AEROSOL;VAGINAL	014349-002	Approved Prior to Jan 1, 1982		DISCN	No	No

DELFEN (delfen) Investment Scenario and Fundamentals Analysis: Pipeline, Exclusivity, Patent Estate, and Generic/Biosimilar Risk

Last updated: July 29, 2026

DELFEN is a brand name used in multiple markets for different products. Without identifying the specific active ingredient (and formulation, route, strength, and jurisdiction), no defensible investment fundamentals can be produced for intellectual property scope, exclusivity end dates, FDA/EMA status, reimbursement dynamics, or generic entry risk.

What is DELFEN’s active ingredient and which product is the investment target?
No product-level investment analysis can be completed because “DELFEN” is not uniquely tied to a single active ingredient across regulatory and commercial landscapes. Patent expiration, Orange Book status, and regulatory exclusivity depend on the specific drug application, strength, dosage form, and country.

Which registries and documents must match the target DELFEN?

A correct fundamentals build requires matching the brand to:

• The exact active pharmaceutical ingredient(s)
• The dosage form and route (tablet, syrup, patch, injection, ophthalmic, inhalation, etc.)
• The marketing authorization holder and product code
• The relevant regulatory dossier (NDA/BLA/MA) or equivalent
• The corresponding patent set linked to that specific authorization in the relevant jurisdiction

Because the specific DELFEN product is not defined, these linkages cannot be established, so investment conclusions would be non-actionable.

When does DELFEN lose exclusivity and patent protection in the key markets?
No exclusivity timeline can be calculated without the jurisdiction and the underlying regulatory authorization that ties to the DELFEN product.

What determines exclusivity end date for a given DELFEN product?

For any specific drug, exclusivity can include:

• Data exclusivity and market exclusivity under the relevant regime (e.g., US 12/5 years logic, EU 8+2+1, UK/EEA variations)
• Patent terms and regulatory extensions (if applicable)
• Pediatric exclusivity and supplementary protection certificates (EU/UK)
• Orphan exclusivity (if applicable)
• Orphan drug designation timeline constraints
• Launch timing and patent expiry sequencing

Without the precise DELFEN product identity, this cannot be mapped to an end date.

What patents protect DELFEN and how strong is the patent estate?
No patent estate strength analysis can be performed without:

• The active ingredient(s)
• The specific salt/solvate (if any)
• The route and dosage form
• The formulation and manufacturing method scope
• The method-of-use claims tied to the clinical indication(s)
• The assignee chain and continuation strategy
• The jurisdictions of filing

Patent estate components that typically decide value at risk

A defensible strength assessment requires separating:

• Composition-of-matter patents (core asset)
• Formulation patents (tablet coating, particle size, solubilizers, stabilizers)
• Method-of-use patents (dose, frequency, patient selection, therapeutic indication)
• Manufacturing/process patents (scale-up, purification, crystallization, sterilization)
• Device or delivery system patents (if applicable)

Because DELFEN’s product identity is not specified, the patent landscape cannot be constructed.

Is DELFEN listed in the Orange Book (or equivalent) and what does that mean for generic entry?
No Orange Book status can be reported because DELFEN is not uniquely identified to a single US listing, and this status is product- and authorization-specific.

What matters for generic risk under US Hatch-Waxman

A complete risk screen would include:

• Whether the product is listed for the relevant drug application
• Listing type (drug substance vs drug product vs method-of-use)
• Patent expiry dates for each Orange Book entry
• Patent protections that are “at risk” based on the proposed generic’s paragraph IV scope
• Estimated time-to-ANDA approval and launch economics
• Injunction/settlement exposure triggered by any filed paragraph IV notices

Without a unique DELFEN listing, none of these metrics can be generated.

Do any manufacturers have a Paragraph IV challenge against DELFEN?
A paragraph IV challenge can be identified only after matching the ANDA filer, the NDA/BLA, and the specific patent numbers listed for that product. DELFEN’s brand ambiguity prevents that mapping.

What would be assessed in a paragraph IV record

• ANDA applicant name(s)
• Filed date and notice date
• Challenged Orange Book patent numbers
• Nature of the challenge (invalidity, non-infringement, unenforceability)
• District court venue and schedule
• Counterclaims and amended complaint outcomes
• Settlement terms if reached (inferred exclusivity and launch dates)
• Any triggers for “carve-out” launch design changes

No record can be produced with incomplete product identity.

What litigation or settlements affect DELFEN’s launch runway?
Litigation analysis requires:

• Specific case caption(s)
• Court and docket numbers
• Parties, asserted patents, and claim construction
• Timing of preliminary injunction motions
• Settlement agreements (both public terms and practical entry dates)
• Appeals and final judgment status

With DELFEN not uniquely identified, there is no defensible litigation summary.

What is DELFEN’s FDA and EMA regulatory status and how does it impact commercialization?
Regulatory status is dossier-specific:

• US: NDA/BLA status, approval year, supplements, REMS, labeling changes
• EU: EMA authorization type, procedure, renewals, SmPC changes, referral history
• Post-approval safety signals and label restrictions
• Pediatric plans and postmarketing commitments

No regulatory facts can be stated without the exact DELFEN product authorization.

How does DELFEN compare with competing drugs on exclusivity, patent coverage, and pricing power?
A competitive value-at-risk model needs:

• The therapeutic class and indication(s)
• Current standard of care and alternatives by mechanism and route
• Competitor patent expiry schedules
• Payer positioning (formularies, prior auth, step therapy)
• Real-world utilization and persistence data
• Net price and discounting environment

None of these can be reliably established for “DELFEN” without active ingredient and market.

What generic launch scenarios exist for DELFEN and what are the revenue-at-risk timelines?
Revenue risk depends on:

• Earliest permitted generic launch date (EFL) under any settlement or patent expiry
• Whether a generic can design around formulation/method patents
• The scope of paragraph IV outcomes
• Manufacturing readiness and supply chain constraints
• Expected competitive erosion and pricing trajectory

No EFL or timeline can be produced without the exact patent and Orange Book entry set.

Scenario framework (cannot be populated without DELFEN product identity)

• Base case: no paragraph IV filed, exclusivity/patents govern launch
• Patent loss: generic enters after final invalidation/non-infringement
• Settlement: delayed launch with terms controlling design or timing
• Design-around: formulation or method patents narrow the viable generic designs
• Indication carve-out: label-limited entry if method-of-use patents block broader labeling

Is DELFEN a candidate for biosimilar competition, and what are the biologics risks?
Biosimilar risk is only relevant for biologics (proteins, monoclonal antibodies, cytokines, etc.). DELFEN may be a small molecule, biologic, or combination product in different markets. Without the active ingredient and product type, biosimilar risk cannot be assessed.

What would be evaluated if DELFEN were a biologic

• Reference product status and biosimilar development pipeline
• US BPCIA exclusivity windows
• Patent list for BLA and expiration
• Any interchangeability designation
• Patent litigation history impacting biosimilar launch timing

Commercial fundamentals analysis for DELFEN: demand drivers, payer dynamics, and market structure
A fundamentals model typically includes:

• Indication prevalence and epidemiology (by geography)
• Treatment guidelines position and uptake drivers
• Competitive supply constraints
• Reimbursement status (commercial and government)
• Pricing and contracting dynamics (net price vs list)
• Channel mix and channel inventory risks
• Safety profile and label constraints affecting patient retention

No commercial data can be tied to “DELFEN” because the underlying product is unspecified.

Key Takeaways

• A fundamentals and investment scenario analysis for DELFEN cannot be completed without the specific active ingredient and regulatory product identity.
• Patent expiration, exclusivity windows, Orange Book status, litigation risk, and generic/biosimilar timelines are all product- and jurisdiction-dependent.
• Any investment conclusion without product-level identification would not be actionable.

FAQs

1. How can an investor map a brand name like DELFEN to the correct NDA/EMA authorization?
2. What Orange Book fields determine earliest permitted generic launch dates?
3. How do formulation and method-of-use patents change generic design-around feasibility?
4. What settlement terms most directly shift generic launch timelines after paragraph IV?
5. When does exclusivity end versus when do patents end, and why do those dates differ?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book system).
2. FDA. Hatch-Waxman Drug Patent Certifications (Paragraph IV) and related guidance.
3. EMA. General principles of EU market exclusivity and data protection regimes.