TUXARIN ER Drug Patent Profile

When do Tuxarin Er patents expire, and what generic alternatives are available?

Tuxarin Er is a drug marketed by Mainpointe and is included in one NDA. There are two patents protecting this drug.

The generic ingredient in TUXARIN ER is chlorpheniramine maleate; codeine phosphate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; codeine phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Tuxarin Er

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 3, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TUXARIN ER

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	TUXARIN ER at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TUXARIN ER

Constraining patent/regulatory exclusivity:

9,107,921

NDA:

206323

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TUXARIN ER

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

US Patents and Regulatory Information for TUXARIN ER

TUXARIN ER is protected by two US patents.

This potential generic entry date is based on patent 9,107,921.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015		RX	No	No	9,066,942
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015		RX	No	No	9,107,921		Y

Expired US Patents for TUXARIN ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015	6,248,363
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015	6,383,471

International Patents for TUXARIN ER

See the table below for patents covering TUXARIN ER around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2003517470
Australia	6083800
Japan	2002537317
Australia	2004243013

Last updated: June 2, 2026

Tuxarin ER market dynamics and financial trajectory: sales drivers, pricing, exclusivity, and generic risk

Executive summary: Tuxarin ER’s commercial trajectory is shaped by (1) the size and refill cadence of its target patient population, (2) net price pressure from payer contracting and therapeutic substitutions, (3) the maturity of its prescriber base versus newer comparators, and (4) the timing and strength of exclusivity and patent barriers that determine when oral modified-release competitors and generics can enter. Market share and revenue should be modeled as an “exclusivity curve” with step-changes at generic/label-expansion events, tempered by formulary access and prior authorization requirements.

No market-size figures, revenue run rates, formulary placement, or Orange Book/patent expiration dates were provided for TUXARIN ER, so a complete, data-backed financial trajectory and exclusivity/generic-entry timeline cannot be produced to the level required for investment, licensing, or litigation use.

What is Tuxarin ER’s commercial positioning and who drives prescribing?

Featured snippet answer: Tuxarin ER’s market position depends on whether payers cover it on preferred tiers for its therapeutic indication, and whether prescribers choose it over immediate-release or alternative extended-release products based on tolerability, dose flexibility, and guideline alignment.

Therapeutic category and patient acquisition dynamics

Tuxarin ER’s sales are typically driven by:

• Initial adoption among prescribers who already manage chronic conditions with oral ER regimens.
• Conversion from immediate-release or older ER products when prescribers value once-daily dosing and steady plasma profiles.
• Ongoing refills tied to persistence and dose stability rather than short-cycle acute use.

How payer design affects real-world demand

Commercial performance in modified-release CNS and metabolic indications usually hinges on:

• Prior authorization and step therapy gates.
• Preferred formulary placement and rebate structures that raise effective net price.
• Patient cost-sharing behavior that reduces adherence when co-pays rise.

Switching friction

Market share shifts after launch tend to face friction:

• Titration periods and clinical comfort with stable ER dosing.
• Pharmacy benefits manager (PBM) switching policies.
• Manufacturer patient support programs and affordability initiatives.

How do pricing and net revenue evolve for Tuxarin ER in the US?

Featured snippet answer: Net sales typically decline from launch peak due to rebate escalation, payer mix shift, and substitution pressure unless protected by exclusivity and strong differentiation.

Net price compression mechanics

For oral ER brands, net price often compresses from:

• Contract renegotiations at renewal.
• Competitive category pressure from new ER entries or cheaper AB-rated alternatives.
• Increased volume-share for manufacturers with stronger contracting.

Gross-to-net drivers

Key levers for financial trajectory:

• Rebate rates tied to formulary status.
• Manufacturer-administered programs that convert to higher rebates over time.
• Distributor and chargebacks that intensify as volume shifts to lower-priced contracts.

Discounting vs volume tradeoff

Even when unit volumes rise, net revenue can flatten if payer contracting becomes more aggressive. The financial model should track both:

• Script growth (TRx)
• Net price per script (or per defined daily dose)
• Mix of covered patients by formulary tier and geography

When does Tuxarin ER lose exclusivity and when could generics enter?

Featured snippet answer: Generic entry timing is determined by the last-to-expire combination of regulatory exclusivity (if any), and Orange Book-listed patents covering the drug substance, drug product, and method of use. The first generic launch window is typically the earliest date when an ANDA can be legally marketed, usually aligned with Hatch-Waxman 180-day exclusivity triggers once a Paragraph IV filer wins.

Exclusivity timeline framework (model)

A correct exclusivity forecast requires:

• Regulatory exclusivity: New Chemical Entity (NCE), New Molecular Entity (NME), pediatric exclusivity, and/or 5-year/3-year exclusivity categories.
• Patent expiration set: composition of matter, formulation/controlled-release, and method-of-use patents.
• Litigation/settlement terms that can delay or accelerate market entry.

No Orange Book/patent expiration dates for TUXARIN ER were provided, so an exclusivity calendar cannot be stated accurately.

Paragraph IV and “first filer” dynamics

When patent barriers exist, the earliest competitive step change usually follows one of:

• A successful Paragraph IV challenge that triggers 180-day exclusivity for the first-to-file ANDA.
• Settlement that grants “carve-out” launch dates or licensing-based delayed entry.

Without case identifiers, settlement dates, and patent numbers, the launch-risk window cannot be tied to actual milestones for Tuxarin ER.

What patent estate protects Tuxarin ER and how strong is it?

Featured snippet answer: For extended-release brands, protection typically spans composition-of-matter and formulation/controlled-release patents, plus method-of-use patents for dosing regimens or patient subsets.

Patent estate components that affect commercial risk

• Drug substance patents: block full generic substitution at the API level.
• Drug product patents: protect specific ER mechanisms (matrix coating, bead technology, osmotic or diffusion systems), dissolution profiles, and excipient systems.
• Method-of-use patents: delay generics even if formulation is cleared, if labeling still infringes.

Freedom-to-operate drivers

Generic risk depends on whether an ANDA is:

• “Carve-out” labeled to non-infringing indications
• Design-around the formulation
• Challenging specific patents via Paragraph IV

No patent list, assignees, jurisdictions, or expiration/expiration-and-litigation status for Tuxarin ER was provided, so strength scoring cannot be completed.

What Orange Book status does Tuxarin ER have and what does it imply for exclusivity?

Featured snippet answer: Orange Book status determines the controlling patents that define the legal entry date for an ANDA. Multiple patent “layers” can delay entry even after some patents expire.

What to extract from Orange Book listings (needed for a full answer)

• Patent numbers and statutory basis (composition, method-of-use, drug product)
• Expiration dates
• Listed NDC(s) and dosage forms
• Exclusivity codes (if applicable)

TUXARIN ER Orange Book listings were not provided, so Orange Book status cannot be stated.

How does Tuxarin ER compete with other extended-release drugs in the same class?

Featured snippet answer: Tuxarin ER’s competitive outcomes depend on formulary tier placement and clinical positioning relative to other ER options, including differences in dosing frequency, titration ease, adverse event profile, and insurance coverage.

Competitive axes

• Net price vs competitors’ contracting rebates
• Clinical differentiation (AEs, onset, switching tolerability)
• Label breadth and guideline inclusion
• Real-world persistence and discontinuation rates

Share shift triggers

• New competitor entry in the same ER category
• PBM formulary moves
• Generic arrival in the “closest” ER comparator

No comparator set, share data, or contracting information was provided, so relative market dynamics cannot be quantified for Tuxarin ER.

What financial trajectory should investors and licensors model for Tuxarin ER?

Featured snippet answer: The base case is a stability-to-growth trajectory during protected launch maturity, followed by step-down risk at generic entry. A downside case accelerates after a payer downgrades tier access or when therapeutic alternatives gain share.

Trajectory model structure

A reliable forecast uses:

1. Script growth curve (TRx CAGR by channel)
2. Net price curve (rebate and discount slope)
3. Net sales = TRx × net price
4. Step-change events tied to exclusivity dates, ANDA approvals, and realized payer contraction

What drives sensitivity

Most sensitivity usually comes from:

• Net price compression after formulary renegotiation
• Persistence (discontinuation rates) and dose switching
• Share loss to therapeutically similar ER products
• Time-to-generic entry

Data requirement gap

A numeric financial trajectory cannot be stated without:

• Reported revenue and units (quarterly or annual) for Tuxarin ER
• TRx and net price metrics by period
• US payer mix and formulary tier penetration
• Exclusivity and generic-entry dates

No such inputs for Tuxarin ER were provided.

Key Takeaways

• Tuxarin ER’s financial trajectory is driven by payer contracting, substitution pressure, and the timing of generic entry governed by regulatory exclusivity and Orange Book-listed patent layers.
• For oral extended-release brands, the most material inflection typically occurs at the intersection of (a) last patent expiration and (b) any Paragraph IV/settlement-related delay or first-filer 180-day exclusivity.
• A fully data-backed revenue forecast and exclusivity/generic-risk timeline cannot be produced here because TUXARIN ER’s Orange Book/patent and commercial metrics were not supplied.

FAQs

1. How do payer formulary tier changes affect Tuxarin ER net sales?
2. What indicators show rising generic risk for an extended-release brand like Tuxarin ER before ANDA approvals?
3. How does 180-day exclusivity for a first Paragraph IV ANDA change the commercial impact on Tuxarin ER?
4. What is the typical revenue decline shape for US oral ER brands after generic entry?
5. How do method-of-use patents change labeling carve-out strategies for generic applicants versus formulation patents?

References

No sources were provided or cited because TUXARIN ER-specific market, Orange Book, and patent data were not included in the prompt.