List of Excipients in Branded Drug ZELSUVMI

Zelsuvmi Excipient Strategy and Commercial Opportunities

Last updated: September 29, 2026

Zelsuvmi is a prescription topical acne treatment containing 10% berdazimer, a nitric-oxide-releasing active ingredient approved by the FDA for the topical treatment of acne vulgaris in adults and pediatric patients aged 9 years and older. Its commercial value depends on more than berdazimer exclusivity. The formulation, pH control, rheology, preservative system, packaging, and manufacturing process create additional barriers to direct substitution and opportunities for differentiated products.

The excipient platform is relatively conventional: water, glycerin, poloxamer 407, carbomer, benzyl alcohol, and sodium hydroxide. The commercial challenge is that the excipients must support nitric oxide generation, physical stability, spreadability, skin tolerability, microbial control, and patient adherence in a leave-on topical product.[1]

What is Zelsuvmi and how does its formulation work?

Zelsuvmi is a topical gel containing berdazimer 10%. Berdazimer is a nitric oxide-releasing drug designed to generate nitric oxide in the skin. Nitric oxide has antimicrobial and anti-inflammatory activity relevant to acne pathophysiology.[1,2]

The FDA-approved product is applied once daily as a thin layer to acne-affected areas. The label identifies the following inactive ingredients:

Excipient	Primary formulation function
Purified water	Continuous aqueous vehicle
Glycerin	Humectant and skin-moisturizing agent
Poloxamer 407	Surfactant, solubilizer, and texture modifier
Carbomer homopolymer Type B	Gelling and viscosity control
Benzyl alcohol	Preservative
Sodium hydroxide	Carbomer neutralization and pH adjustment

The formulation is a water-based semisolid rather than an anhydrous ointment or oil-dominant cream. That design supports facial application and cosmetic acceptability, but it increases the importance of microbial preservation, packaging integrity, pH control, and compatibility with the nitric oxide-releasing active.[1]

What excipients protect the commercial performance of Zelsuvmi?

The core excipient strategy is a coordinated system rather than a single differentiated ingredient.

Carbomer controls dose uniformity and application behavior

Carbomer provides the gel structure. Its concentration and neutralization state determine viscosity, spreadability, residence time, and the amount of product delivered per application.

For acne products, viscosity has direct commercial relevance. A gel that is too thin can run, separate, or produce poor dosing control. A gel that is too viscous can be difficult to spread over large facial areas and may reduce adherence. Carbomer also helps keep berdazimer uniformly distributed through the product.

Carbomer performance is sensitive to:

• pH;
• ionic strength;
• neutralization level;
• polymer grade;
• mixing energy;
• temperature; and
• raw-material variability.

These variables create potential process and formulation barriers for a generic or follow-on manufacturer even when the excipient names are disclosed.

Sodium hydroxide controls gel formation and pH

Sodium hydroxide is likely used primarily to neutralize the carbomer and adjust the finished-product pH. That function has two consequences.

First, it establishes the final rheology of the gel. Second, pH can affect the chemical behavior of berdazimer and the rate or extent of nitric oxide release. A competing product that uses the same listed ingredients but delivers a different pH profile could have different stability, release, skin tolerability, or clinical performance.

pH is therefore a likely critical quality attribute. It should be controlled across manufacturing lots, stability conditions, and container configurations.

Poloxamer 407 supports wetting and texture

Poloxamer 407 can function as a nonionic surfactant, solubilizer, wetting agent, and texture modifier. In a topical gel, it can improve active dispersion and contribute to smooth application.

Its nonionic character may reduce incompatibility with charged polymer systems compared with ionic surfactants. The excipient can also influence the sensory profile of the product, including slip, residue, and washability.

Poloxamer concentration is a potential differentiation point for authorized generics and reformulated products. Increasing it may improve wetting but can change tack, foaming, skin feel, and active release.

Glycerin supports skin feel and tolerability

Glycerin is a humectant that attracts and retains water. It can reduce the dry or tight skin sensation associated with topical acne treatment and improve application comfort.

The commercial role of glycerin is significant because acne patients often use multiple products, including cleansers, retinoids, benzoyl peroxide, and moisturizers. A formulation that reduces dryness and irritation may improve persistence even if its pharmacologic active is identical.

Too much glycerin, however, can increase tackiness and alter drying time. The target is a balance between moisturization and a non-greasy finish.

Benzyl alcohol provides preservation but creates positioning limits

Benzyl alcohol is listed as a preservative. Because Zelsuvmi is an aqueous multi-dose topical product, preservation is necessary unless the package and manufacturing system provide an alternative microbial-control strategy.

Benzyl alcohol also creates opportunities for reformulation. A competitor could evaluate:

• a different preservative system;
• a preservative-free single-use package;
• a lower-preservative formulation;
• an airless pump;
• a multidose package with improved microbial exclusion; or
• a formulation designed for patients who report preservative sensitivity.

A preservative change would not be a minor commercial adjustment. It could affect antimicrobial effectiveness, skin irritation, extractables and leachables, stability, and regulatory comparability.

How does Zelsuvmi compare with other topical acne products?

Zelsuvmi competes in a crowded topical acne market that includes benzoyl peroxide, topical retinoids, topical antibiotics, azelaic acid, and fixed-dose combinations.

Product category	Main active mechanism	Typical formulation issue	Competitive implication
Zelsuvmi	Nitric oxide release from berdazimer	Stability, pH, gel uniformity, preservation	Non-antibiotic differentiated mechanism
Benzoyl peroxide	Antimicrobial and comedolytic activity	Irritation, bleaching, oxidation	Low-cost generic competition
Adapalene	Retinoid activity	Dryness, irritation, photostability	Strong generic availability
Tretinoin	Retinoid activity	Light and oxidation sensitivity	Numerous formulations and strengths
Clindamycin combinations	Antibiotic activity	Resistance and duration limits	Combination products remain common
Azelaic acid	Antimicrobial and keratolytic activity	Texture and tolerability	Prescription and nonprescription competition

Zelsuvmi’s most important product-level distinction is its non-antibiotic nitric oxide mechanism. That positioning may appeal to prescribers seeking to avoid topical antibiotic exposure and to patients who cannot tolerate benzoyl peroxide or retinoids.

The principal commercial weakness is likely price pressure from established generic topical therapies. Excipient performance must therefore support a visible patient benefit, such as improved tolerability, spreadability, reduced residue, or adherence.

What formulation patents and manufacturing rights could protect Zelsuvmi?

The strongest formulation protection would normally cover the relationship among berdazimer concentration, excipient ranges, pH, viscosity, particle or dispersion characteristics, nitric oxide release, and topical use.

Potential claim categories include:

1. A pharmaceutical composition containing berdazimer at a specified concentration with defined carbomer, poloxamer, glycerin, preservative, and pH ranges.
2. A topical gel with specified viscosity or rheological properties.
3. A composition that releases nitric oxide over a defined period after application.
4. A method of treating acne with once-daily topical administration.
5. A packaging system that maintains stability or controls moisture and oxygen exposure.
6. A manufacturing method that produces uniform dispersion of berdazimer.
7. Stability specifications linking assay, degradation products, viscosity, pH, and nitric oxide release.

The excipient list itself is unlikely to provide meaningful standalone protection. Commercial protection is stronger when the excipient system is tied to measurable performance characteristics, such as release rate, stability, viscosity, skin deposition, or clinical tolerability.

A follow-on manufacturer could attempt to design around composition claims by changing:

• the gelling polymer;
• the preservative;
• the pH range;
• the active concentration;
• the surfactant;
• the package;
• the manufacturing sequence; or
• the physical state of berdazimer.

Those changes can create regulatory comparability problems. A different gel structure may alter product performance even if the same active ingredient is used.

When does Zelsuvmi lose regulatory exclusivity?

Zelsuvmi received FDA approval in December 2023. The product has five years of new chemical entity exclusivity from the approval date, subject to statutory conditions. That period generally prevents submission of an abbreviated new drug application citing Zelsuvmi before the applicable date, although patent certification and submission timing depend on the Orange Book listing and the challenger’s legal strategy.[3]

Zelsuvmi is approved for acne vulgaris in patients aged 9 years and older. FDA approval does not eliminate patent-based barriers after regulatory exclusivity expires. A generic applicant may still face listed patents, pediatric exclusivity, method-of-use restrictions, or litigation.

Milestone	Date or status
FDA approval	December 2023
Active ingredient	Berdazimer
Strength	10% topical gel
Dosage form	Topical gel
Indication	Acne vulgaris
Minimum labeled age	9 years
New chemical entity exclusivity	Expected to run approximately five years from approval, subject to statutory calculation
Generic pathway	Likely ANDA, subject to product-specific FDA requirements
Biosimilar pathway	Not applicable because berdazimer is a small-molecule active, not a biologic

What Orange Book and Paragraph IV risks exist for Zelsuvmi?

Zelsuvmi is a small-molecule topical drug, so competitive entry would generally proceed through the ANDA pathway rather than the biosimilar pathway.

A generic applicant could file a Paragraph IV certification against listed patents. The patent holder could then bring an infringement action within the statutory period, potentially triggering a 30-month stay of FDA approval under the Hatch-Waxman framework.[4]

The principal Paragraph IV risk areas are likely to include:

• composition-of-matter claims covering berdazimer or a nitric oxide-releasing chemical structure;
• topical composition claims;
• method-of-use claims covering acne treatment;
• manufacturing claims;
• stability or packaging claims; and
• claims directed to specific excipient ranges or pH conditions.

A generic challenger has a stronger design-around position if it can use the same active ingredient in a materially different gel system without infringing composition claims. Its regulatory burden rises if the changed excipients alter viscosity, release, skin permeation, local tolerability, or product performance.

For commercial planning, three entry scenarios are relevant:

Scenario	Commercial timing	Likely impact
No successful challenge	After listed patent and exclusivity barriers	Originator retains pricing control longer
At-risk generic launch	Before final patent resolution	High litigation exposure and possible damages
Settled entry	Date fixed by agreement	Predictable erosion, often before complete patent expiry

No biosimilar pathway applies to Zelsuvmi. The relevant competitive threat is an ANDA product or a reformulated topical product with a different regulatory route.

What commercial opportunities exist in Zelsuvmi excipients?

Preservative-free or low-preservative products

A preservative-free version could target patients with sensitive skin or a history of irritation. The most practical approach would likely require a package that limits microbial ingress, such as a unit-dose container or airless pump.

The opportunity is commercially meaningful only if the new package does not create unacceptable dispensing waste, cost, or dose variability.

Improved cosmetic acceptability

A competing gel could optimize:

• rapid drying;
• low tack;
• low shine;
• reduced residue;
• improved spreadability;
• compatibility with sunscreen and cosmetics; and
• reduced pilling when layered with moisturizers.

These attributes are important in facial acne because adherence depends on daily usability.

Sensitive-skin positioning

A formulation with lower irritation potential could target patients who discontinue benzoyl peroxide or retinoids because of dryness, erythema, or peeling. Excipient changes could include alternative preservatives, different humectant ratios, buffering adjustments, or a less aggressive solvent system.

Any tolerability claim would require clinical support. A softer skin feel alone would not establish lower irritation.

Combination products

Berdazimer could potentially be evaluated in combination with other acne actives, including retinoids, benzoyl peroxide, or keratolytic agents. The main technical barriers would be chemical compatibility, oxidant sensitivity, pH conflicts, and preservation.

Combination products could expand market share but would increase development complexity. Benzoyl peroxide, for example, introduces oxidation and stability concerns that could affect a nitric oxide-releasing active.

Geographic and channel expansion

The formulation may support international expansion if the active and excipients satisfy local requirements. Key regional issues include:

• preservative restrictions;
• labeling requirements;
• pediatric-use standards;
• cosmetic-versus-drug classification;
• container closure requirements;
• local stability conditions; and
• permitted claims.

The product is also suitable for specialty dermatology promotion, teledermatology, and pharmacy-based acne treatment pathways. Commercial execution will depend on reimbursement, copay support, formulary placement, and prescriber familiarity with berdazimer.

How strong is the Zelsuvmi excipient strategy?

The excipient strategy is technically credible but not inherently difficult to reproduce. The likely defensibility comes from the interaction between berdazimer, pH, carbomer neutralization, nitric oxide release, preservation, and packaging.

Its strengths are:

• simple patient-friendly aqueous gel;
• once-daily topical administration;
• non-antibiotic mechanism;
• established topical excipients;
• potential for broad facial application; and
• formulation attributes that can support skin tolerability.

Its vulnerabilities are:

• conventional excipients may be available to generic manufacturers;
• generic topical development can focus on matching performance rather than copying every manufacturing detail;
• low-cost acne alternatives are numerous;
• benzyl alcohol creates an opportunity for preservative-free competition; and
• the commercial premium must be supported by clinical and adherence advantages.

The most defensible commercial position would combine composition patents with process controls, package protection, demonstrated product performance, and clinical evidence showing tolerability or adherence advantages over generic acne therapies.

Key Takeaways

• Zelsuvmi contains 10% berdazimer in a water-based topical gel.
• Its principal excipients are glycerin, poloxamer 407, carbomer, benzyl alcohol, sodium hydroxide, and purified water.
• Carbomer and sodium hydroxide jointly control gel structure, viscosity, and pH.
• Poloxamer 407 supports wetting, dispersion, and application feel.
• Benzyl alcohol provides preservation but creates a possible reformulation opportunity.
• The most relevant follow-on threat is an ANDA generic, not a biosimilar.
• Composition, pH, viscosity, nitric oxide release, packaging, and manufacturing claims may provide stronger protection than the excipient list alone.
• Commercial opportunities include preservative-free packaging, improved cosmetic feel, sensitive-skin positioning, international expansion, and combination products.
• Zelsuvmi’s commercial premium will depend on tolerability, adherence, reimbursement, and differentiation from inexpensive generic acne treatments.

FAQs

Is Zelsuvmi a biologic that can face biosimilar competition?

No. Zelsuvmi contains berdazimer, a small-molecule active ingredient. Competitive entry would generally use the ANDA pathway rather than the biosimilar pathway.

Which Zelsuvmi excipient is most important for viscosity?

Carbomer is the principal gelling agent. Sodium hydroxide adjusts its neutralization state and therefore influences the final viscosity and gel structure.

Could a generic Zelsuvmi use different excipients?

Yes, subject to FDA requirements for pharmaceutical equivalence, bioequivalence, product performance, and applicable patent restrictions. A different excipient system could create challenges in matching viscosity, release, stability, and local tolerability.

Why could a preservative-free Zelsuvmi formulation be commercially attractive?

A preservative-free product could appeal to patients with sensitive skin or preservative concerns. It would likely require a package that limits microbial contamination, such as a unit-dose or airless system.

Can Zelsuvmi be combined with benzoyl peroxide or a retinoid?

A combination product would require separate formulation and clinical development. Compatibility, oxidation, pH, stability, irritation, and preservative performance would need to be established before commercialization.

References

1. U.S. Food and Drug Administration. (2023). ZELSUVMI (berdazimer) gel, 10% prescribing information. FDA.

2. U.S. Food and Drug Administration. (2023). FDA approves new treatment for acne. FDA.

3. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.

4. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585.