List of Excipients in Branded Drug PROCENTRA

Generic Drugs Containing PROCENTRA

Company	Ingredient	NDC	Excipient
INDEPENDENCE PHARMACEUTICALS LLC	dextroamphetamine sulfate	21724-701	ANHYDROUS CITRIC ACID
INDEPENDENCE PHARMACEUTICALS LLC	dextroamphetamine sulfate	21724-701	BENZOIC ACID
INDEPENDENCE PHARMACEUTICALS LLC	dextroamphetamine sulfate	21724-701	SACCHARIN SODIUM

What are the Most Frequently-Used Excipients in PROCENTRA?

# Of NDCs	Excipient
1	ANHYDROUS CITRIC ACID
1	BENZOIC ACID
1	SACCHARIN SODIUM

ProCentra Excipient Strategy and Commercial Opportunities

Last updated: August 4, 2026

ProCentra is an immediate-release dextroamphetamine sulfate oral solution marketed by Tris Pharma for attention-deficit/hyperactivity disorder. Its commercial position is based on liquid dosing, pediatric usability, and avoidance of tablet-swallowing barriers rather than a long-duration patent moat. The strongest opportunities are differentiated taste masking, preservative and packaging improvements, flexible dosing, and alternative liquid amphetamine products.

ProCentra contains dextroamphetamine sulfate at 5 mg per 5 mL. The listed excipients include citric acid, glycerin, methylparaben, potassium sorbate, sodium citrate, sucralose, flavoring, and purified water.[1] The product is a Schedule II controlled substance and is subject to FDA approval, controlled-substance manufacturing requirements, and supply-chain controls.

What is ProCentra and how does its formulation work?

ProCentra is a ready-to-use oral solution rather than a tablet, capsule, or extended-release suspension.

Attribute	ProCentra profile
Active ingredient	Dextroamphetamine sulfate
Dosage form	Immediate-release oral solution
Strength	5 mg per 5 mL
Therapeutic area	ADHD
FDA pathway	NDA
NDA holder	Tris Pharma
Controlled-substance status	Schedule II
Administration	Oral, measured liquid dose
Primary patient segment	Pediatric and other patients with swallowing or dose-flexibility needs
Core formulation challenge	Taste, chemical stability, preservative performance, and dosing accuracy

The formulation uses an acidic citrate buffer, sweetener, humectant, preservatives, and flavor. The excipient system has several functions:

• Citric acid and sodium citrate control pH.
• Sucralose provides sweetness without adding substantial sugar.
• Glycerin contributes body and mouthfeel.
• Methylparaben and potassium sorbate support antimicrobial preservation.
• Flavoring reduces the bitterness associated with dextroamphetamine.
• The liquid vehicle permits dose titration in increments smaller than available tablet strengths.

The formulation is commercially practical but not technically difficult to replicate. A competing product can potentially use the same excipients, equivalent excipients, or a different excipient system if it demonstrates pharmaceutical equivalence, stability, microbial quality, and acceptable labeling.

What excipients are used in ProCentra?

The principal excipient strategy combines acidification, sweetness, viscosity control, preservation, and flavor masking.

Acidic buffer system

Citric acid and sodium citrate provide pH control. The buffer can influence:

• Dextroamphetamine sulfate stability.
• Preservative activity.
• Flavor perception.
• Compatibility with the container closure.
• Microbial control.

A competing formulation that changes the buffer system would need to assess pH, degradation products, preservative efficacy, and extractables and leachables. A shift toward phosphate, acetate, or another buffer could improve taste or stability in some systems, but it would create new development and comparability work.

Sweetener and taste masking

Sucralose is the primary listed sweetener. Dextroamphetamine has a bitter, medicinal taste that can remain detectable after sweetening. The principal commercial opportunity is not simply to increase sweetness. Excessive sweetness can create an unpleasant aftertaste and can reduce adherence in children.

Potential taste-masking approaches include:

• Alternative high-intensity sweetener combinations.
• Flavor systems with rapid onset and longer persistence.
• Bitter-blocking agents.
• Ion-pairing or complexation approaches.
• Resin-based taste masking.
• Microencapsulation of the active ingredient.
• Higher-viscosity vehicles that reduce immediate drug release in the mouth.

Taste masking that changes dissolution, absorption, dose uniformity, or bioavailability may move the product outside a straightforward pharmaceutical-equivalence strategy.

Glycerin and mouthfeel

Glycerin provides body and can improve mouthfeel. It also contributes to the product's sweetness and viscosity. A formulation with lower glycerin may reduce gastrointestinal tolerability concerns or improve pourability, while a higher-viscosity system may slow swallowing and reduce bitter taste exposure.

Viscosity must remain compatible with dosing syringes. Excessive viscosity can create dose-retention problems in the syringe, inaccurate dispensing, and residue in the bottle.

Preservatives

Methylparaben and potassium sorbate provide antimicrobial protection in a multidose liquid. A preservative system is commercially useful because a multidose bottle reduces packaging cost and improves convenience. It also introduces consumer and regulatory sensitivities involving:

• Preservative exposure.
• Paraben preferences.
• Sorbate stability.
• pH dependence.
• Preservative efficacy over the in-use period.
• Compatibility with plastic packaging.

A preservative-free ProCentra alternative could command a premium if supplied in unit-dose containers or a validated closure system. The economics depend on packaging cost, fill-volume loss, shipping, and patient adherence.

What formulation patents protect ProCentra?

ProCentra's patent position is weaker than that of a new chemical entity because dextroamphetamine sulfate is an established active ingredient and the product is an immediate-release oral solution.

Public FDA records identify ProCentra as NDA 022592. The FDA Orange Book is the controlling public source for listed patents and exclusivity associated with the approved NDA.[2,3] Patent numbers, expiration dates, and listing status should not be inferred from the existence of the product or from unrelated Tris Pharma amphetamine products.

The commercial protection can be divided into four categories:

Protection category	Relevance to ProCentra
Active-ingredient patent	Effectively unavailable as a meaningful barrier because dextroamphetamine is an established drug
Formulation patent	Potentially relevant if claims cover a specific excipient, pH, stability profile, or taste-masking system
Method-of-use patent	Possible, but narrow unless the approved labeling supports a distinct patient or dosing method
Regulatory exclusivity	Depends on the NDA approval history and current FDA records

A formulation patent would be strongest if it claims a measurable technical result, such as improved chemical stability, reduced degradation, enhanced preservative performance, or a defined taste-masking effect. Broad claims covering a dextroamphetamine solution with ordinary sweeteners and preservatives would face greater validity and obviousness risk.

When does ProCentra lose exclusivity?

ProCentra's most important loss-of-exclusivity question is not the expiry of dextroamphetamine itself. It is whether any currently listed formulation or method-of-use patents remain enforceable and whether FDA regulatory exclusivity still affects an abbreviated application.

The relevant exclusivity types are:

Exclusivity type	Commercial impact
New chemical entity exclusivity	Not expected to protect this established active ingredient
Orphan-drug exclusivity	Not applicable to the ADHD indication
Pediatric exclusivity	Could add six months to qualifying protections if granted
Three-year clinical-investigation exclusivity	Depends on the NDA approval basis and qualifying new clinical studies
Patent protection	Depends on current Orange Book listings and enforceability
Controlled-substance requirements	Continue after patent expiry and can delay or limit supply

A generic manufacturer could target a 505(j) ANDA if it can demonstrate pharmaceutical equivalence and bioequivalence or satisfy FDA's applicable requirements for an oral solution. A 505(b)(2) application would be more relevant for a materially different formulation, delivery system, concentration, preservative strategy, or taste-masking platform.[4]

Are Paragraph IV challenges likely for ProCentra?

A Paragraph IV challenge is commercially plausible if an Orange Book-listed patent blocks an ANDA. For a straightforward dextroamphetamine oral solution, the main risk to the incumbent is an ANDA that reproduces the dosage form and uses a non-infringing excipient system.

Potential Paragraph IV targets would include:

• Formulation patents covering pH or buffer ranges.
• Preservative-system claims.
• Stability claims.
• Taste-masking claims.
• Container-closure or dispensing-system claims.
• Method-of-use patents with narrow dosing language.

A Paragraph IV filing can trigger patent litigation under the Hatch-Waxman framework. If litigation is filed within the statutory period, FDA approval may be subject to a 30-month stay, subject to the statutory rules and court developments.[5]

The litigation risk is likely lower than for a complex extended-release amphetamine product because an immediate-release oral solution has fewer release-rate mechanisms and fewer potential infringement points. The risk increases if ProCentra has listed patents directed to a specific liquid formulation or if the proposed generic adopts the same formulation architecture.

What formulation opportunities exist for a ProCentra competitor?

Preservative-free unit-dose solution

A unit-dose product could remove methylparaben and potassium sorbate. It would require packaging that maintains sterility or microbiological quality appropriate to the dosage form. Oral liquid unit-dose packaging could include single-use cups, sachets, or premeasured oral syringes.

Commercial advantages include:

• Lower preservative exposure.
• Better dose accuracy.
• Reduced contamination after opening.
• Improved adherence in schools and supervised-care settings.
• Potential premium pricing.

The disadvantages are higher packaging cost, more material usage, and greater shipping volume.

Improved taste-masking system

Taste masking is the most direct product-differentiation opportunity. A competing formulation could combine a bitter blocker with a more durable flavor system and a lower-intensity sweetener profile.

The key development endpoint is patient acceptance, not merely laboratory sweetness. The formulation must maintain dose uniformity, chemical stability, and acceptable palatability over the labeled shelf life.

Higher-concentration solution

A higher-concentration product could reduce administration volume. ProCentra provides 5 mg in 5 mL, equal to 1 mg/mL. A 2 mg/mL or 5 mg/mL solution could reduce the volume required for larger doses.

The commercial tradeoff is greater dosing risk. Small measurement errors produce larger dose deviations. A higher-concentration product would need a clear oral syringe, dose-limiting presentation, and labeling that reduces confusion with the existing strength.

Sugar-free and allergen-positioned products

ProCentra already uses sucralose rather than sucrose as the principal sweetener. A competing product could target specific consumer preferences with:

• Alternative sweeteners.
• A different flavor profile.
• Reduced excipient count.
• Allergen-positioned flavor systems.
• A lower-viscosity, easier-to-rinse formulation.

These changes may be commercially meaningful even when they do not create strong patent protection.

Ready-to-administer dosing systems

A prefilled oral syringe or unit-dose dispenser could improve school administration and reduce caregiver measurement errors. The delivery system could generate stronger intellectual-property protection than a conventional bottle if it claims:

• A calibrated dose chamber.
• A child-resistant and tamper-evident system.
• A dose-locking mechanism.
• A closure that prevents repeated access.
• A package designed for controlled-substance accountability.

How does ProCentra compare with other liquid amphetamine products?

ProCentra competes with immediate-release tablets, other liquid amphetamine products, and extended-release liquid formulations.

Product type	Main advantage	Main limitation	Patent and regulatory profile
ProCentra oral solution	Flexible dosing and no tablet swallowing	Short duration and taste burden	Likely vulnerable to solution-based generic competition
Dextroamphetamine tablets	Low cost and established supply	Swallowing and dose increments	Mature generic market
Mixed amphetamine salts solution	Broad stimulant familiarity	Different active-ingredient composition and taste	Product-specific patent and exclusivity analysis
Extended-release amphetamine liquid	Longer duration	More complex formulation and potentially higher price	Stronger formulation and release-control opportunity
Amphetamine oral suspension	Long duration and reduced daily dosing	Shake-dependent dose uniformity and higher formulation complexity	More complex regulatory and patent barriers

The main strategic distinction is duration of action. ProCentra's immediate-release profile supports dose flexibility but usually requires multiple daily administrations. Extended-release products can capture patients and prescribers seeking once-daily treatment, while immediate-release liquids retain value for initial titration, afternoon dosing, and patients who cannot swallow solid dosage forms.

What manufacturing and intellectual-property barriers affect ProCentra?

Manufacturing barriers are moderate rather than extreme. The product does not require a biologic process, sterile filling, or a sophisticated extended-release matrix. The important controls are:

• Accurate dextroamphetamine assay and content uniformity.
• Control of pH and degradation products.
• Preservative efficacy.
• Flavor uniformity.
• Container-closure compatibility.
• Oral syringe calibration.
• Controlled-substance security and reconciliation.
• Prevention of cross-contamination in multiproduct facilities.
• DEA quota and scheduling compliance.

The active ingredient is commercially sensitive because dextroamphetamine is controlled. A reliable API source, quota allocation, and secure manufacturing process can be more important than a narrow formulation patent.

Packaging can create a practical barrier. A product that requires a specialized oral syringe, child-resistant closure, tamper evidence, or unit-dose filling may have higher launch costs and longer scale-up timelines than a conventional bottle.

What is the FDA and Orange Book status of ProCentra?

ProCentra is an FDA-approved prescription product under NDA 022592.[1] It is not a biologic, so biosimilar substitution and the Biologics Price Competition and Innovation Act do not apply. Competition would arise through an ANDA, a 505(b)(2) application, other approved stimulant products, or compounded products where legally permitted.

Orange Book status should be evaluated using the current FDA listing for NDA 022592. The commercially relevant questions are:

1. Whether any patents are listed against the NDA.
2. Whether those patents cover the approved oral solution or only a related formulation.
3. Whether the patent terms have expired.
4. Whether pediatric or other regulatory exclusivity remains.
5. Whether FDA has approved therapeutically equivalent ANDAs.
6. Whether a generic applicant has submitted a Paragraph IV certification.

An approved ANDA for the same strength and dosage form would materially reduce the value of excipient differentiation unless the branded product has a meaningful taste, packaging, dosing, or supply advantage.

What licensing deals and commercial partnerships are relevant?

Publicly disclosed commercial information does not establish a major licensing transaction specifically tied to ProCentra's excipient technology. Tris Pharma's broader value proposition includes liquid and extended-release drug-delivery platforms, but platform-level capabilities should not be treated as ProCentra-specific rights.

The most credible partnership opportunities involve:

• Co-development of a preservative-free liquid.
• Licensing of a taste-masking system.
• Contract manufacturing of controlled-substance oral liquids.
• Pediatric packaging and oral syringe technology.
• Regional commercialization of an approved or 505(b)(2) product.
• Supply agreements for dextroamphetamine API and specialized flavors.

A licensee would need freedom-to-operate analysis around formulation claims, dispensing devices, flavor systems, and any Tris-related platform patents.

How strong is the ProCentra patent estate?

The estate appears strategically limited unless current Orange Book records identify active formulation patents with meaningful remaining term. Dextroamphetamine sulfate is an old active ingredient, and the immediate-release solution format is comparatively accessible to generic manufacturers.

Patent strength is therefore likely to depend on claim specificity:

Patent characteristic	Assessment
Broad oral-solution claims	Vulnerable to validity and obviousness attacks
Narrow pH or excipient claims	Potentially enforceable but easier to design around
Demonstrated stability or taste advantage	Stronger technical basis
Device-specific claims	Potentially useful for lifecycle management
Method-of-use claims	Narrow commercial value unless prescribing practice is differentiated
Manufacturing claims	Useful if process is difficult to reproduce and commercially necessary

The strongest lifecycle strategy would combine a differentiated formulation with a proprietary dispensing system and evidence of improved adherence or tolerability.

What generic launch scenarios exist for ProCentra?

Scenario 1: Direct ANDA launch

A manufacturer files an ANDA for dextroamphetamine sulfate oral solution at the same concentration and dosage form. This is the highest-probability generic pathway if no enforceable patent or regulatory exclusivity blocks approval.

Scenario 2: Paragraph IV-led launch

A generic applicant challenges an Orange Book-listed formulation patent. The launch timing would depend on litigation, settlement terms, patent outcomes, and any 180-day exclusivity held by the first eligible Paragraph IV filer.

Scenario 3: 505(b)(2) differentiated liquid

A sponsor develops a higher-concentration, preservative-free, taste-masked, or device-enabled product. This route can provide stronger product differentiation but requires more clinical, formulation, and regulatory justification.

Scenario 4: Extended-release substitute

A long-acting liquid or suspension competes for the same pediatric and swallowing-impaired population. This does not require direct substitution for ProCentra to create commercial pressure. Prescriber preference can shift toward once-daily dosing.

What revenue exposure does ProCentra create?

Product-specific revenue is not publicly disclosed in the FDA label or standard regulatory records. Revenue exposure should therefore be assessed through prescription volume, net price, duration of therapy, payer coverage, and the proportion of patients requiring liquid dosing.

The main exposure points are:

• Generic erosion after approval of an equivalent oral solution.
• Switching to extended-release liquid products.
• Supply interruptions caused by controlled-substance quotas or API constraints.
• Payer preference for lower-cost stimulant alternatives.
• Limited differentiation among conventional sweetened oral liquids.
• Price compression after multiple generic entrants.

The strongest commercial defense is a product that reduces caregiver burden, improves patient acceptance, and supports accurate supervised dosing. A conventional bottle with ordinary sweetness has limited long-term pricing power once equivalent generics enter.

Key Takeaways

• ProCentra is a 1 mg/mL immediate-release dextroamphetamine sulfate oral solution marketed by Tris Pharma.
• Its excipient system uses citrate buffering, sucralose, glycerin, methylparaben, potassium sorbate, and flavoring.
• The principal formulation opportunities are taste masking, preservative-free unit dosing, higher concentration, and improved dispensing systems.
• The product is a conventional small-molecule controlled substance, not a biologic, so biosimilar risk is irrelevant.
• Generic risk is structurally meaningful because the active ingredient is established and the dosage form is relatively accessible.
• A direct ANDA is likely to be more commercially feasible than a complex 505(b)(2) product unless the competitor seeks a differentiated formulation or device.
• Patent strength depends on current Orange Book listings and the specificity of any formulation or device claims.
• Manufacturing and controlled-substance supply requirements may create more practical friction than the underlying formulation technology.
• Product-specific revenue is not publicly disclosed, so the commercial opportunity is best assessed through liquid-dosing demand, generic timing, payer coverage, and product differentiation.

FAQs About ProCentra Excipient Strategy and Market Competition

Can a generic manufacturer use the same excipients as ProCentra?

Yes, if the proposed product meets applicable pharmaceutical-equivalence, quality, stability, bioequivalence, labeling, and manufacturing requirements. Using the same excipients does not by itself establish patent infringement, but the applicant must assess any listed formulation claims.

Is ProCentra a biologic or biosimilar product?

No. ProCentra is a small-molecule dextroamphetamine sulfate oral solution. Competition is governed by the ANDA and 505(b)(2) frameworks, not the biosimilar pathway.

Could a preservative-free ProCentra competitor obtain separate patent protection?

Potentially. Protection could focus on a specific preservative-free formulation, package, in-use stability profile, unit-dose container, or dispensing system. Patent value would depend on claim scope and demonstrated technical advantages.

What is the biggest patient-facing weakness of ProCentra's formulation?

Taste is the principal patient-facing challenge. Dextroamphetamine's bitterness can remain perceptible despite sweetener and flavor, particularly in pediatric patients and at higher doses.

Would a higher-strength ProCentra solution be commercially attractive?

It could reduce administration volume and improve convenience for patients requiring larger doses. The principal risks are dosing errors, concentration confusion, and the need for a dispensing device that maintains accurate measurement.

Sources

1. U.S. Food and Drug Administration. (2010). ProCentra (dextroamphetamine sulfate) oral solution prescribing information, NDA 022592.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database.
4. U.S. Food and Drug Administration. (2022). Guidance for industry: Applications covered by Section 505(b)(2).
5. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417.