When do the patents on PERIDEX expire, and when will PERIDEX go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Solventum	PERIDEX	chlorhexidine gluconate	SOLUTION;DENTAL	019028-001	Aug 13, 1986	AT	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: July 27, 2026

PERIDEX (chlorhexidine gluconate oral rinse) is a legacy antiseptic drug with an unusually crowded, long-running IP and regulatory footprint driven by (1) multiple dosage forms and strengths, (2) formulation and method-of-use claims that persist across newer filings, and (3) ongoing generic competition. Investment relevance is therefore less about near-term “blockbuster” exclusivity capture and more about pricing power, supply stability, managed-care formulary positioning, and the ability to win tenders against authorized generics and Par/OTC substitutes.

This analysis focuses on the enforceable US patent estate and FDA regulatory posture that typically govern generic entry risk for PERIDEX across oral-care indications (notably gingivitis and oral hygiene/periodontal conditions under label-directed use).

What is PERIDEX and what markets does it actually monetize?

PERIDEX is the branded chlorhexidine gluconate oral rinse used for oral antisepsis. Commercial performance is shaped by three structural demand drivers:

Dental professional prescribing patterns for short-cycle antiseptic regimens tied to dental procedures and periodontal/gingivitis-related management.
Chronic substitution by OTC and private-label chlorhexidine-type antiseptics in some channels, depending on local availability and labeling.
Generic penetration because chlorhexidine gluconate is chemically simple and manufacturing is mature.

From an investment lens, PERIDEX tends to behave like a defensible niche oral antiseptic rather than a high-volume specialty biologic. The value proposition is often tied to:

contract pricing with dental distributors,
rebids for hospital and institutional formularies,
and retention of brand margin versus authorized generics.

PERIDEX product forms that matter for IP and competition

Even within “PERIDEX,” different presentations can map to different Orange Book listings:

oral rinse (solution)
different strengths and package formats
labeling that drives method-of-use patent coverage

What patents protect PERIDEX in the US and how many are on the Orange Book?

Featured-snippet answer: PERIDEX’s US IP protection is typically anchored in an Orange Book patent listing structure that includes formulation, method-of-use, and manufacturing-use patents for chlorhexidine gluconate oral rinses, with additional coverage sometimes extending through later CIPs (continuation-in-part) and reformulation families.

However, a complete, litigation-ready patent inventory requires an authoritative Orange Book pull and docket-level confirmation. Without that dataset, no defensible claim-by-claim “how many patents” count can be produced.

How strong is the patent estate for PERIDEX and what drives enforceability?

PERIDEX’s enforceability profile is usually driven by:

Claim scope breadth: formulation patents often narrow to specific concentrations, excipient systems, or pH/viscosity windows.
Method-of-use claims tied to label: if a method claim requires the exact regimen in the FDA-approved labeling, it can deter non-labeled generic uses.
Generic workarounds: because chlorhexidine chemistry is established, generics can often design around by changing formulation or dosing instructions, depending on how the claims are written.
Timing of claim grants and continuations: legacy brands often accumulate patent families over years, but enforceability depends on whether the Orange Book-listed claims remain in force and unchallenged.

Investment implication: for legacy antiseptics, “strong estate” often means the brand retains negotiated share rather than blocking every generic entry indefinitely.

When does PERIDEX lose exclusivity in the US?

Featured-snippet answer: PERIDEX’s exclusivity horizon is governed by the latest-in-force Orange Book patents and any available periods of exclusivity attached to the original NDA or later supplements, not by chemistry-level expectations alone.

No precise expiration dates can be stated here without the Orange Book listing dates and the latest patent term status for each listed product/strength.

What generic entry risks exist for PERIDEX and what do Paragraph IV challenges usually target?

Generic entry risk for PERIDEX follows standard Hatch-Waxman pathways:

ANDAs to generic chlorhexidine oral rinse seeking approval to the branded reference product.
Paragraph IV certifications targeting one or more Orange Book-listed patents.
30-month stay and settlement-triggered launch timing.

In practice, Paragraph IV challenges against antiseptic oral rinses tend to target:

formulation patents (composition/excipients),
and method-of-use claims if they are written as regimen instructions.

Investment implication: if PERIDEX has multiple unexpired Orange Book-listed patents, generic entrants may file multiple ANDAs with different certification strategies, generating staggered launch risks rather than a single “cliff” date.

What patent litigation affects PERIDEX and how do settlements change launch timing?

PERIDEX’s litigation pattern, when present, is typically settlement-driven:

generics agree to carve-out of certain patents,
brands receive delayed-launch dates,
and/or generics adopt design-arounds.

Because the settlement date determines pricing compression impact, the key investment question is whether settlements set a delayed launch beyond the latest unexpired Orange Book patent for each product/strength. A docket-level analysis requires specific court filings and dates.

What is the FDA regulatory status of PERIDEX and what pathway governs generics?

PERIDEX is an FDA-approved drug. For generic competition, the regulatory mechanism is:

ANDA referencing the brand’s NDA.

Commercial implication:

Generic approval depends on bioequivalence and labeling parity rather than clinical endpoints that are usually required for new molecular entities.
That limits innovation-driven upside and makes brand margin more sensitive to pricing competition.

What formulations are protected by PERIDEX patents (and how do pH and excipients impact design-around)?

Chlorhexidine gluconate oral rinses are sensitive to:

pH range
viscosity/feel
stability under storage
mouthfeel and irritation profile
excipient systems that reduce precipitation or degradation

Where patents tie to those parameters, generics can attempt:

different excipient systems,
different pH targets,
or alternate manufacturing methods.

Investment implication: design-around success reduces the brand’s ability to extract value beyond “market access,” turning IP into a narrower shield.

How does PERIDEX compare with competing chlorhexidine oral rinses and antiseptic products?

Competitive comparison for investors usually turns on:

formulary placement (dental insurance and hospital dental services)
net price after rebates
availability and fill-rate
substitutability with other chlorhexidine products and non-chlorhexidine antiseptics

PERIDEX’s main competitive set typically includes:

generic chlorhexidine gluconate rinses,
other dental antiseptics with different active ingredients,
and in some markets, OTC antiseptics.

The core investment read: if PERIDEX holds a differentiated customer contract (not just OTC shelf), it can maintain higher net pricing even after generic launches.

What commercialization fundamentals support or weaken an investment case for PERIDEX?

Investment fundamentals for PERIDEX are driven by:

1) Pricing pressure after generic entry

Once multiple AB-rated generics exist for the same strength and label, net pricing usually converges toward low-cost supply. Brands can retain premium only if they control:

distribution terms,
tender requirements,
or specific institutional formularies.

2) Supply chain resilience

Oral rinse manufacturing requires stable inputs and consistent quality controls. In antiseptic generics, supply disruptions can produce short-lived pricing recovery, which matters for near-term profitability.

3) Channel mix

dental clinics and institutional dental procurement can offer longer rebid cycles,
while retail channels compress more quickly via shelf substitutes.

4) Regulatory and labeling stability

If the label stays stable, generic approval and substitution occur faster and with less friction.

What revenue exposure exists across strengths and package sizes?

Even with one active ingredient, investments should map to:

strength-specific formulations,
pack sizes,
and any package-level device or kit positioning.

When different strengths have separate Orange Book patent lists, generic entry can hit unevenly, creating delayed erosion in some SKUs while others face immediate AB substitution.

How does PERIDEX’s investment risk profile compare with newer oral care brands?

PERIDEX has a different risk profile than newer therapeutics:

lower R&D-driven uncertainty (mature chemistry),
higher market-access dependency,
and higher sensitivity to generic pricing dynamics.

For investment underwriting, this means scenario analysis should overweight:

contract duration and rebate structures,
competitor capacity,
and patent/litigation timelines that govern launch dates.

Key Takeaways

PERIDEX is a legacy chlorhexidine oral rinse with value driven more by market access and pricing discipline than by new exclusivity.
Investment upside is typically limited to periods before the next permitted generic launch and any supply-driven pricing volatility.
Generic entry risk is governed by Orange Book-listed patents and Hatch-Waxman Paragraph IV dynamics, not by broad chemistry assumptions.
Patent strength tends to be claim-scope dependent (formulation, method-of-use, and manufacturing-related limitations), with design-around a core risk.
The highest-yield diligence item for underwriting is a SKU-by-SKU Orange Book and litigation timeline mapping to net pricing impact windows.

FAQs

How do I track PERIDEX generic launch risk by SKU and strength?
Use Orange Book listings and ANDA certification histories to map which patents attach to each strength and pack.
Do method-of-use patents matter for generic PERIDEX substitution?
Yes, when claims require specific labeled regimens. If generic labeling diverges, method claims can be harder to enforce.
Can generics design around chlorhexidine oral rinse formulation patents?
Often by changing excipient systems, pH targets, and manufacturing parameters when those are claimed with sufficient specificity.
What settlement terms most affect PERIDEX profitability?
The effective launch dates, carve-outs, and whether settlement covers all strengths and package formats.
What regulatory events accelerate PERIDEX pricing erosion?
ANDA approvals with effective-date triggers, especially when multiple AB-rated products launch simultaneously.

References

FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
FDA Hatch-Waxman Drug Products and Related Documents. US FDA.

PERIDEX Drug Patent Profile

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Peridex

AI Deep Research

Questions you can ask:

Summary for PERIDEX

US Patents and Regulatory Information for PERIDEX

PERIDEX (chlorhexidine gluconate) patent, exclusivity, and investment fundamentals analysis