When will the TYLENOL W/ CODEINE NO. 2 patents expire, and when will TYLENOL W/ CODEINE NO. 2 go generic?

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	TYLENOL W/ CODEINE NO. 2	acetaminophen; codeine phosphate	TABLET;ORAL	085055-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ 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 21, 2026

Tylenol W/ Codeine No. 2 (Acetaminophen + Codeine) Investment Scenario and Patent/Regulatory Fundamentals

Executive summary: Tylenol W/ Codeine No. 2 (acetaminophen USP 300 mg + codeine phosphate USP 30 mg per tablet; “APAP-codeine #2”) is a mature, controlled-substance combination with limited incremental IP headroom, low manufacturing complexity, and persistent but declining US brand attractiveness. For investors, the value driver is less about breakthrough IP and more about (1) enforcement and supply stability for a DEA-controlled analgesic, (2) channel and insurer contracting dynamics, (3) ongoing opioid risk and labeling/liability pressures, and (4) whether the company holds any meaningful formulation, method, or packaging patents that can delay generic or abuse-deterrent competition. In most standard scenarios, commercial upside hinges on remaining market share plus reimbursement and access rather than patent runway.

What is Tylenol W/ Codeine No. 2 and how is it sold in the US?

Featured snippet answer: Tylenol W/ Codeine No. 2 is an oral immediate-release combination tablet of acetaminophen and codeine phosphate, dispensed under DEA controlled-substance rules with analgesic indications and opioid safety limitations.

Brand and product characterization

Drug class: opioid (codeine) plus analgesic/antipyretic (acetaminophen)
Dosage form: tablet, oral, immediate release
Typical strength: acetaminophen 300 mg + codeine phosphate 30 mg per tablet (commonly referenced as “No. 2”)

Controlled-substance and distribution implications for investment

Codeine is DEA Schedule II controlled substance when used as a single-ingredient product or in certain combination contexts; combination products can vary by formulation and regulatory classification, but the distribution and prescribing environment is tightly managed.
That control constrains the addressable retail footprint, increases compliance costs, and makes supply disruptions material.

Revenue fundamentals that typically matter more than IP for mature opioids

Net pricing is driven by wholesaler and PBM contracting, not list price
Volume is constrained by prescriber behavior shifts toward non-opioids and abuse-deterrent alternatives
Regulatory labeling, prior authorization, and payer controls affect access

What patents protect acetaminophen + codeine No. 2 in the US, and how strong is the IP estate?

Featured snippet answer: For APAP-codeine combination products, the core composition and basic dosing are generally old and widely covered by early filings that are unlikely to provide a long US exclusivity runway today; any remaining value typically comes from late-life formulation, packaging, or manufacturing method patents.

Where investment value typically survives

In late-life opioid/analgesic combinations, the only defensible “incremental” protection usually comes from:

formulation refinements (e.g., changed dissolution behavior, stability engineering)
manufacturing/process patents
packaging and handling designs (tamper-resistance)
labeling or REMS-specific exclusivity is rarely available as a standard “property” that supports a long monopoly for generics

Why this matters for an investor

If the US patent estate is thin or expired, the commercial case becomes defensible only via:
- brand stickiness and payer relationships
- legal and regulatory friction against entrants
- supply chain resilience and quality performance
If the estate is active but narrow, generic entry can still occur “around” claims via product engineering or process redesign.

Patent estate scoring framework (investment use)

For an APAP-codeine combination, the practical scoring model investors apply is:

Composition-of-matter: usually weak due to age
Method-of-manufacture: sometimes survives as narrow exclusory leverage
Formulation/controlled release/abuse-deterrence: often the only segment that can create real differentiation in a generic-heavy market
Legal enforceability (remaining term, claim breadth, prosecution history): key gate

Actionable investment conclusion: Treat Tylenol W/ Codeine No. 2 as an IP-light, contract-and-risk-management-dependent asset unless a current, broad and enforceable late-life patent is confirmed for this specific strength, dosage form, and formulation.

When does Tylenol W/ Codeine No. 2 lose exclusivity, and what does that imply for generic entry risk?

Featured snippet answer: For mature combination opioid products, US exclusivity is typically already largely expired; generic risk is structurally high, with entry timing driven by patent-by-patent survivability and Orange Book listing status rather than by broad composition exclusivity.

Exclusivity and entry risk timeline mechanics investors use

Generic launch risk is primarily governed by:

Orange Book listed patents (where applicable) and their expiration dates
Whether any listed patents are still in force
Whether generic applicants pursue Paragraph IV certification (FDA ANDA)
Whether settlements delay launch

What “high probability” looks like commercially

In the absence of active, enforceable formulation/process patents, multiple ANDAs can be approved around the same period
Even if patents exist, narrow claims can enable design-around or carve-out formulations

Actionable investment conclusion: For Tylenol W/ Codeine No. 2, assume generic entry and price compression are baseline outcomes; underwriting should focus on brand margin resilience, supply stability, and legal/regulatory barriers rather than exclusivity.

What is the Orange Book status of Tylenol W/ Codeine No. 2?

Featured snippet answer: The Orange Book status determines whether there are still FDA-listed, patent-tied exclusivity constraints; for mature combination analgesics, Orange Book listings are often limited or already expired for the primary listed patents.

How investors use Orange Book listings

Identify listed patent numbers tied to the drug product
Map each listed patent to an expiration date
Track current litigation status (if any) for listed patents
Link each listed patent to likely ANDA entry windows

Business consequence of Orange Book lightness

If few patents remain or all are expired, FDA approval does not imply a settlement or delay
Competitive intensity increases, and margin protection becomes a procurement and contracting exercise

Are there Paragraph IV challenges for acetaminophen + codeine No. 2, and what litigation outcomes matter most?

Featured snippet answer: Paragraph IV challenges drive entry timing and settlement economics; for older combination opioids, the frequency of challenges can be high, but the value of any single challenge depends on whether it is tied to still-in-force claims.

Litigation and settlement components investors underwrite

Whether the case is settled before an ANDA “skinny label” or design-around
Whether the settlement includes:
- agreed launch dates
- license payments or reverse payments
- non-infringement/design-around carve-outs
Whether enforcers are brand owner vs. authorized generics

Why this is central to returns

Patent litigation creates a temporary hold on generic supply
Settlement terms determine how fast price compression hits

Actionable investment conclusion: For a mature APAP-codeine combination, treat litigation outcomes as episodic price catalysts but underwrite baseline generic competition at current market pricing levels unless there is clear evidence of pending, still-active listed patents.

How does Tylenol W/ Codeine No. 2 compare with other opioid combination products on IP and commercialization?

Featured snippet answer: Comparisons typically show that multi-ingredient opioid analgesics are commodity-like after the core composition patents expire; differentiation tends to shift to abuse-deterrent technologies, payer restrictions, and supply reliability.

Competitive peer sets investors benchmark

APAP-codeine variants (“No. 2,” “No. 3,” “No. 4” depending on the market)
Other immediate-release opioid + APAP combinations (e.g., hydrocodone/APAP families)
Where available: abuse-deterrent opioids and alternative analgesic classes

What tends to drive relative performance

Payer formularies and prior authorization intensity
Formulary positioning relative to non-opioid options
Safety-related labeling scrutiny and risk management requirements
Availability and manufacturing continuity

What FDA regulatory pathway governs Tylenol W/ Codeine No. 2, and what does it mean for competitors?

Featured snippet answer: For a mature brand, generic products typically seek ANDA approval under 505(j); the competitive lever is bioequivalence and patent certifications rather than new clinical evidence.

Regulatory mechanics investors use

ANDA requires bioequivalence and chemistry manufacturing controls
Patent certifications (Paragraph I-IV) define whether approval triggers immediate entry or stays pending litigation
Labeling alignment with the brand drives substitution and pharmacy dispensing

Safety labeling impacts on market penetration

Opioid-containing products face tightening prescribing controls, REMS-like structures (where applicable), and payer utilization management
Label language affects:
- prescriber comfort
- insurer coverage
- substitution likelihood

What manufacturing and IP barriers exist for generic or authorized generic entrants?

Featured snippet answer: For an immediate-release APAP-codeine tablet, manufacturing barriers are generally moderate; the biggest barrier is often quality systems and regulatory compliance rather than IP.

Typical technical hurdles

consistent content uniformity for low-dose opioid component
stability management for acetaminophen in finished tablets
robust control of dissolution and impurity profiles

IP barriers that can still matter

narrow process patents can raise cost of proof in bioequivalence equivalence and validation
packaging and tamper-related claims can restrict direct copying if enforced

Actionable investment conclusion: Underwrite competition based on manufacturing scalability and compliance capacity; assume IP barriers are either expired or narrow unless confirmed otherwise for this specific product/strength.

Investment scenario: bull, base, and bear cases

Featured snippet answer: For Tylenol W/ Codeine No. 2, the base case is continued generic price pressure with stable-to-declining volumes, while upside requires either temporary IP/litigation-driven delay or successful payer/channel retention; downside is faster substitution and enforcement-driven declines plus liability-related risk.

Base case (most likely underwriting)

Generic competition persists with periodic entry waves
Brand market share declines gradually
Pricing reflects contracting and volume mix
Returns rely on cost control and supply reliability

Bull case (what would have to be true)

There is still meaningful, enforceable patent coverage for product-specific features, delaying generic entrants
Litigation or settlement terms extend profitability
Payer restrictions evolve in a way that keeps the brand positioned above generics
Supply disruptions at rivals temporarily favor channel allocation

Bear case (what would break the model)

Faster generic saturation leading to steep margin compression
Increased payer access restrictions or substitution mandates
Operational issues that reduce ability to meet demand
Renewed liability or opioid policy changes affecting utilization materially

Key metrics investors should track for Tylenol W/ Codeine No. 2

Volume trend: prescription counts and claims per month
Net price: realized pricing net of rebates and chargebacks
Channel inventory: wholesaler days and buy-sell dynamics
Generic penetration: number of approved products and market share shifts
Patent/litigation: remaining term on any listed patents and current case posture
Regulatory and payer actions: formulary changes, prior auth thresholds, and step therapy adoption

Key Takeaways

Tylenol W/ Codeine No. 2 is a mature, controlled-substance combination where investment returns usually depend more on contracting and risk management than on a long remaining patent runway.
The generic entry threat is structurally high unless product-specific, still-active Orange Book-listed patents exist and are enforceable.
Litigation and Paragraph IV outcomes can create short-term price protection, but underwriting should assume persistent price compression from generic competition.
The most actionable diligence targets are Orange Book status for the specific strength and formulation, current litigation posture tied to those listings, and payer/channel dynamics that determine realized net pricing.

FAQs

What are the main drivers of net price for Tylenol W/ Codeine No. 2 in the US?
How do Paragraph IV settlements typically affect launch timing for generic acetaminophen-codeine tablets?
What regulatory labeling or opioid policy changes most influence prescribing of APAP-codeine products?
Which product attributes (strength, tablet type, packaging) most affect whether generics can design around IP?
How does reimbursement management (P&T formularies, prior authorization, step therapy) change utilization for opioid/APAP combinations?

References (APA)

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
FDA. ANDA Regulatory Requirements (505(j)). U.S. Food and Drug Administration. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda
FDA. Hatch-Waxman Act and Patent Certifications (Paragraph I-IV). U.S. Food and Drug Administration. https://www.fda.gov/drugs/hatch-waxman-drug-development-and-patent-procedures

US Patents:	0
Applicants:	1
NDAs:	1

AI Deep Research

Questions you can ask:

Summary for TYLENOL W/ CODEINE NO. 2