HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX Drug Patent Profile

Which patents cover Hydrocodone Polistirex And Chlorpheniramine Polistirex, and when can generic versions of Hydrocodone Polistirex And Chlorpheniramine Polistirex launch?

Hydrocodone Polistirex And Chlorpheniramine Polistirex is a drug marketed by Tris Pharma Inc and is included in one NDA.

The generic ingredient in HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX is chlorpheniramine polistirex; hydrocodone polistirex. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine polistirex; hydrocodone polistirex profile page.

Summary for HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Patent Applications:	1,254
DailyMed Link:	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX at DailyMed

Recent Clinical Trials for HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX

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

Sponsor	Phase
Mallinckrodt	Phase 1

See all HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX clinical trials

Pharmacology for HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX

Drug Class	Histamine-1 Receptor Antagonist Opioid Agonist
Mechanism of Action	Histamine H1 Receptor Antagonists Opioid Agonists

US Patents and Regulatory Information for HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tris Pharma Inc	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	091632-001	Oct 1, 2010		RX	No	Yes

Hydrocodone Polistirex and Chlorpheniramine Polistirex Market Dynamics and Financial Trajectory

Last updated: August 9, 2026

Hydrocodone polistirex and chlorpheniramine polistirex is the active-ingredient combination in Tussionex Pennkinetic Extended-Release Suspension, a prescription cough product containing an opioid antitussive and an antihistamine. The product has a mature commercial profile, limited differentiation outside its extended-release suspension technology, and substantial exposure to opioid prescribing controls. Its financial trajectory is likely stable to declining in the branded market, with revenue supported by residual demand for prescription cough therapy but constrained by generic competition, controlled-substance scrutiny, and the broader decline in opioid utilization.

What is hydrocodone polistirex and chlorpheniramine polistirex?

Hydrocodone polistirex and chlorpheniramine polistirex is an extended-release oral suspension for temporary relief of cough and upper-respiratory symptoms. The product is marketed as Tussionex Pennkinetic Extended-Release Suspension.

The formulation combines:

Component	Function	Pharmacology
Hydrocodone polistirex	Antitussive	Opioid cough suppressant
Chlorpheniramine polistirex	Antihistamine	Reduces histamine-mediated symptoms
Polistirex resin complex	Extended-release delivery system	Controls release in the gastrointestinal tract

The labeled dose for adults and children 12 years and older is 5 mL every 12 hours, with a maximum of 10 mL in 24 hours. The product is not indicated for children younger than six years under the current U.S. labeling because of the risk of respiratory depression and opioid toxicity. [1]

Hydrocodone polistirex is not the same molecular form as hydrocodone bitartrate used in many immediate-release opioid products. The polistirex complex is designed to provide prolonged release and reduce dosing frequency.

What is the FDA regulatory status of Tussionex?

Tussionex is an FDA-approved prescription drug and contains hydrocodone, a Schedule II controlled substance in the United States. Its regulatory profile is defined by the FDA-approved labeling, controlled-substance requirements, pediatric warnings, and opioid safety restrictions.

Regulatory item	Status
U.S. dosage form	Extended-release oral suspension
Administration	Oral
Prescription status	Prescription-only
Controlled substance	Schedule II because of hydrocodone
Primary therapeutic use	Temporary relief of cough and upper-respiratory symptoms
Pediatric use	Restricted; contraindications and warnings apply to young children
Abuse potential	High relative to non-opioid cough medicines
Key safety risks	Respiratory depression, sedation, misuse, addiction, overdose

The FDA has repeatedly tightened opioid labeling and safety communications. Those measures affect the prescribing environment for hydrocodone-containing cough products even when the product is used for a non-pain indication. [2]

The product also faces a structural regulatory disadvantage against non-opioid cough products. Physicians and pharmacists can substitute products containing dextromethorphan, benzonatate, antihistamines, or expectorants without the same Schedule II controls.

Who markets hydrocodone polistirex and chlorpheniramine polistirex?

Tussionex has historically been associated with UCB and later with Tris Pharma following the transfer of U.S. commercial rights. Tris Pharma is a privately held specialty pharmaceutical company with a portfolio that includes prescription, over-the-counter, and specialty products.

The commercial ownership history matters because Tussionex is not a high-growth innovative medicine. Its value is linked to brand recognition, manufacturing continuity, controlled-substance compliance, and the ability to defend or maintain distribution rather than to new clinical development.

The product’s commercial characteristics include:

• Established physician and pharmacist recognition.
• A liquid dosage form useful for patients who have difficulty swallowing tablets.
• Twice-daily dosing compared with more frequent immediate-release products.
• A controlled-substance classification that limits broad promotional expansion.
• Dependence on respiratory-season demand and acute-care prescribing.
• Limited opportunity for indication expansion.

How large is the market for prescription opioid cough medicines?

The prescription opioid cough market is a mature and contracting segment. Market demand is affected by respiratory infections, seasonal cough incidence, physician prescribing behavior, retail pharmacy controls, and public policy regarding opioid exposure.

Tussionex competes with two broad product groups:

Segment	Examples	Competitive effect
Opioid cough products	Hydrocodone-containing cough syrups, codeine cough products	Direct competition; subject to controlled-substance restrictions
Non-opioid cough products	Dextromethorphan, benzonatate, guaifenesin combinations	Lower regulatory friction and broader prescribing potential
Antihistamine/decongestant products	Chlorpheniramine, brompheniramine, pseudoephedrine combinations	Treat related symptoms without hydrocodone
Generic formulations	Generic extended-release or equivalent suspension products	Price pressure and formulary substitution

The product retains a niche where clinicians value prolonged cough suppression and a liquid formulation. That niche is narrower than the historical prescription cough market because of the opioid epidemic, FDA warnings, state prescribing restrictions, and increased use of non-opioid alternatives.

The commercial market is seasonal. Sales typically rise during fall and winter respiratory illness periods and weaken during warmer months. Annual performance can therefore vary with influenza, respiratory syncytial virus, COVID-19, and other respiratory infection patterns.

What patents protect hydrocodone polistirex and chlorpheniramine polistirex?

The principal historical intellectual-property protection was associated with the extended-release polistirex delivery system and the branded product rather than with new chemical entities. Hydrocodone and chlorpheniramine are long-established active ingredients, so composition-of-matter exclusivity does not create a current barrier.

Potential protection categories include:

1. Formulation patents covering the resin-drug complex.
2. Manufacturing patents covering the suspension and release-control process.
3. Drug-product patents covering dosage strength, particle characteristics, or release performance.
4. Trademark rights covering Tussionex and related branding.
5. Regulatory exclusivity associated with any approved supplemental application, where applicable.

What is the Orange Book status of Tussionex?

The FDA Orange Book is the controlling source for current listed patents, drug-product descriptions, therapeutic-equivalence codes, and approved products. Historical extended-release cough formulations may have had patent listings, but the commercial importance of those patents declines as listed terms expire and generic applicants rely on abbreviated approval pathways. [3]

The relevant patent analysis is therefore less about active composition-of-matter rights and more about:

• Whether any formulation patent remains listed.
• Whether a generic applicant can certify Paragraph IV against a listed patent.
• Whether the generic product has the same dosage form and release characteristics.
• Whether manufacturing know-how creates practical supply barriers after legal exclusivity ends.

No current value should be assigned to historical patent rights without confirming their Orange Book status and expiration dates in the applicable FDA edition.

When does hydrocodone polistirex lose exclusivity?

The product’s core chemical ingredients are long off patent. Any remaining exclusivity would arise from formulation, regulatory, or commercial rights rather than from the active ingredients themselves.

The relevant loss-of-exclusivity sequence is:

Exclusivity layer	Commercial status
Active ingredients	Long expired
Original product approval	Mature
Brand trademark	Potentially continuing, subject to renewal and use
Formulation patents	Must be assessed by current Orange Book records
Regulatory exclusivity	Not the main current barrier
Generic competition	The principal long-term risk

For a mature prescription liquid, generic entry can reduce price even when the brand remains commercially available. Pharmacy substitution and payer formulary rules can accelerate that shift.

Which companies are challenging the product?

Generic competition can arise through an ANDA for the same or therapeutically equivalent extended-release oral suspension. Potential applicants may challenge listed patents through Paragraph IV certifications or may file after relevant patents expire.

The competitive set has historically included large generic manufacturers and specialty liquid-formulation companies. The most important competitive capabilities are:

• Controlled-substance manufacturing authorization.
• Liquid suspension production.
• Resin-complex formulation expertise.
• Stability data for a heterogeneous suspension.
• Reliable supply of hydrocodone and chlorpheniramine.
• DEA compliance and quota management.
• Retail pharmacy distribution.

For this product, manufacturing capability may be a greater practical barrier than patent protection. A generic manufacturer must maintain content uniformity, dose consistency, release characteristics, preservative performance, and physical stability throughout shelf life.

What formulation patents protect the product?

The polistirex system is the main technical differentiator. It binds drug molecules to an ion-exchange resin and controls release as the complex passes through the gastrointestinal tract.

Formulation-related barriers may include:

• Resin selection and particle-size distribution.
• Drug-loading method.
• Release profile across pH conditions.
• Suspension viscosity and redispersibility.
• Dose uniformity from the first to the last measured dose.
• Flavoring and palatability.
• Preservative system.
• Container-closure compatibility.
• Stability under transport and storage conditions.

These technical characteristics can delay or complicate generic development. They do not automatically create enforceable patent exclusivity. A generic applicant may design around a formulation claim or demonstrate pharmaceutical equivalence through an alternative manufacturing process.

What patent litigation affects hydrocodone polistirex and chlorpheniramine polistirex?

The main litigation risk would involve an ANDA applicant asserting that a listed formulation or drug-product patent is invalid, unenforceable, or not infringed. Such a dispute would normally arise under the Hatch-Waxman framework after a Paragraph IV notice.

Potential litigation outcomes include:

Outcome	Commercial consequence
Patent upheld	Generic launch delayed until patent expiry or settlement date
Patent invalidated	Earlier generic launch possible
Non-infringement finding	Branded formulation protection weakened
Settlement with launch date	Predictable but potentially earlier generic entry
No litigation	Generic may enter after patent expiry or regulatory approval

The product’s age reduces the likelihood that litigation over basic hydrocodone or chlorpheniramine composition claims would be commercially relevant. Any litigation value is concentrated in current formulation or manufacturing claims.

How strong is the patent estate?

The patent estate is likely weak to moderate as a long-term commercial defense.

Strengths

• Complex extended-release suspension manufacturing.
• Potential formulation know-how.
• Brand recognition.
• Controlled-substance supply and compliance requirements.
• Liquid dosage form that may reduce the number of capable generic suppliers.

Weaknesses

• Old active ingredients.
• Limited opportunity for new chemical patent protection.
• Declining clinical preference for opioid cough products.
• Availability of non-opioid alternatives.
• Potential generic substitution.
• Restricted use in children.
• No clear high-growth indication pathway.

The commercial moat is therefore operational and brand-based rather than primarily patent-based.

What is the financial trajectory of Tussionex?

Public company filings generally do not report Tussionex revenue as a standalone line item. Tris Pharma is privately held, and product-level net sales, gross margin, and prescription volumes are not broadly disclosed.

A reasonable financial model is:

Period	Expected commercial pattern
Historical peak	Supported by established brand recognition and prescription cough demand
Mature branded period	Stable or declining unit volume, with pricing and seasonal variability
Generic-entry period	Price erosion, formulary substitution, and possible brand volume loss
Long-term mature period	Residual niche sales, primarily through brand loyalty and liquid-form demand

Revenue drivers include:

• Winter respiratory-season intensity.
• Retail prescription volume.
• Wholesale acquisition price.
• Payer reimbursement.
• Generic availability.
• Hydrocodone quota and supply conditions.
• Physician willingness to prescribe opioid cough therapy.
• Pharmacy dispensing restrictions.

Revenue pressures include:

• Lower opioid prescribing.
• FDA and state-level opioid controls.
• Substitution with non-opioid medicines.
• Generic price competition.
• Negative perception of opioid cough products.
• Limited pediatric use.
• Low potential for indication expansion.

The product can remain profitable after substantial volume erosion because mature liquid products may have established manufacturing processes and relatively limited clinical-development costs. The principal financial sensitivity is gross-to-net erosion after generic entry, not research-and-development spending.

What generic launch scenarios exist?

Scenario 1: No near-term generic pressure

The brand retains pricing power if no therapeutically equivalent generic is widely available and if the formulation remains difficult to manufacture. Revenue declines gradually through lower prescribing but margins remain comparatively strong.

Scenario 2: Single generic entrant

A single generic may capture pharmacy substitution while the brand preserves some cash-pay, prescriber-loyal, or supply-constrained demand. Net price declines are meaningful, but the brand can retain a residual share.

Scenario 3: Multiple generic entrants

Several approved manufacturers would produce sharper price erosion. Wholesalers and payers would favor lower-cost alternatives, and the product would become a low-growth maintenance asset.

Scenario 4: Supply disruption

Controlled-substance quota constraints or manufacturing interruptions could temporarily shift demand toward the brand or another supplier. Such events would increase short-term volatility but would not improve the product’s long-term market outlook.

What licensing deals affect the product?

Tussionex’s commercial history includes rights transfers and portfolio transactions involving the branded product. The most relevant economic issue is control of U.S. marketing and distribution rights, not a new platform license.

A licensing or acquisition agreement would be valued on:

• Remaining branded cash flow.
• Patent and regulatory status.
• Manufacturing transferability.
• Controlled-substance compliance infrastructure.
• Generic threat timing.
• Seasonal prescription demand.
• Gross-to-net discounts.
• Supply obligations.

Because product-level financial terms are not generally disclosed, the asset is more appropriately analyzed as part of a broader specialty-pharmaceutical portfolio than as a separately reported public-company franchise.

How does Tussionex compare with non-opioid cough medicines?

Attribute	Tussionex	Dextromethorphan products	Benzonatate	Guaifenesin combinations
Controlled substance	Yes, Schedule II	Generally no	No	No
Dosing	Every 12 hours	Product-dependent	Product-dependent	Product-dependent
Formulation	Extended-release suspension	Syrup, liquid, tablet, capsule	Capsule	Liquid, tablet, capsule
Abuse risk	High	Lower, but misuse is possible	Lower	Low
Pediatric flexibility	Restricted	Varies by product and age	Restricted in young children	Varies
Generic pressure	High	High	High	High
Commercial growth potential	Limited	Broader consumer market	Stable niche	Broad consumer market

Tussionex’s main product advantage is prolonged cough suppression in a liquid formulation. Its main disadvantage is the regulatory and safety burden created by hydrocodone.

What geographic coverage does the product have?

The product’s principal commercial relevance is in the United States, where the Tussionex brand, FDA approval, DEA controls, and U.S. pharmacy distribution determine its economics.

International expansion is constrained by:

• National opioid controls.
• Different cough-treatment guidelines.
• Local registration requirements.
• Divergent controlled-substance schedules.
• Limited demand for opioid antitussives.
• Availability of non-opioid alternatives.

The U.S. market is therefore the central value driver. Geographic diversification is limited compared with products distributed across broad global markets.

Key Takeaways

• Hydrocodone polistirex and chlorpheniramine polistirex is the active combination in Tussionex Pennkinetic Extended-Release Suspension.
• The product is a mature, prescription-only, Schedule II opioid cough medicine.
• Its commercial differentiation comes from extended-release polistirex technology and liquid dosing, not new chemical entities.
• The financial trajectory is likely stable to declining, with seasonal demand and limited public product-level revenue disclosure.
• Generic entry, opioid prescribing restrictions, and non-opioid alternatives are the main commercial risks.
• Manufacturing complexity may delay or limit generic supply, but it is not equivalent to durable patent exclusivity.
• The strongest residual value lies in brand recognition, distribution, formulation know-how, and cash generation from an established product.
• Current Orange Book records and FDA-approved product listings control any definitive assessment of active patents and Paragraph IV exposure.

FAQs

Is hydrocodone polistirex the same as hydrocodone bitartrate?

No. Hydrocodone polistirex is a resin-complex form designed for extended release. Hydrocodone bitartrate is used in other immediate-release or combination opioid products.

Is Tussionex still commercially available?

Tussionex has been marketed in the United States as an extended-release oral suspension. Commercial availability can vary by distributor, pharmacy inventory, controlled-substance supply, and manufacturer allocation.

Can Tussionex be substituted with a generic?

Substitution depends on FDA therapeutic-equivalence status, state pharmacy law, payer policy, and whether an approved generic extended-release suspension is commercially available.

Does chlorpheniramine create a separate patent barrier?

Chlorpheniramine is an old antihistamine and does not provide modern composition-of-matter protection. Any relevant protection would be tied to the combined formulation, release system, or manufacturing process.

What is the biggest investment risk for this product?

The largest risks are declining opioid cough prescribing, generic price erosion, controlled-substance supply restrictions, and the lack of a credible path to major volume growth.

References

1. U.S. Food and Drug Administration. (2023). Tussionex Pennkinetic extended-release suspension: Prescribing information. FDA.
2. U.S. Food and Drug Administration. (2018). FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older. FDA Drug Safety Communication.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA, Center for Drug Evaluation and Research.