ACETADOTE Drug Patent Profile

Which patents cover Acetadote, and what generic alternatives are available?

Acetadote is a drug marketed by Cumberland Pharms and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in eleven countries.

The generic ingredient in ACETADOTE is acetylcysteine. There are three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Acetadote

A generic version of ACETADOTE was approved as acetylcysteine by HOSPIRA on August 30^th, 1994.

Summary for ACETADOTE

International Patents:	18
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	14
Patent Applications:	193
Drug Prices:	Drug price information for ACETADOTE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACETADOTE
What excipients (inactive ingredients) are in ACETADOTE?	ACETADOTE excipients list
DailyMed Link:	ACETADOTE at DailyMed

See drug prices for ACETADOTE

Recent Clinical Trials for ACETADOTE

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

Sponsor	Phase
University of Missouri-Columbia	Phase 1
Shandong Provincial Hospital	Phase 1
Central South University	Phase 1

See all ACETADOTE clinical trials

Pharmacology for ACETADOTE

Drug Class	Antidote Antidote for Acetaminophen Overdose Mucolytic
Mechanism of Action	Reduction Activity
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration

Paragraph IV (Patent) Challenges for ACETADOTE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACETADOTE	Injection	acetylcysteine	200 mg/mL, 30 mL vials	021539	3	2012-04-04

US Patents and Regulatory Information for ACETADOTE

ACETADOTE is protected by three US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes	9,327,028
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes	8,722,738
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes	8,148,356		Y

Expired US Patents for ACETADOTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	8,399,445
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	8,653,061

International Patents for ACETADOTE

See the table below for patents covering ACETADOTE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2619441	COMPOSITION D'ACETYLCYSTEINE ET SES UTILISATIONS (ACETYLCYSTEINE COMPOSITION AND USES THEREFOR)
China	103038356	Acetycysteine compositions and methods of use thereof
Japan	2009506030
Australia	2006282030	Acetylcysteine composition and uses therefor

Last updated: April 24, 2026

What are the market dynamics and financial trajectory for ACETADOTE?

Acetadote is the U.S. brand name for acetylcysteine (N-acetylcysteine, “NAC”) used as an antidote for acetaminophen (paracetamol) overdose and for other indications (notably as a mucolytic in other geographies and products). Market dynamics for “ACETADOTE” are driven less by patent-led brand power and more by: (1) procurement channels (hospital and government buying), (2) competitor parity of acetylcysteine supply and pricing, (3) FDA/labeling-driven demand triggers (acetaminophen overdose incidence, clinical protocols), and (4) generic substitution where exclusivity has lapsed.

Financial trajectory for the product line under “Acetadote” is therefore typically shaped by pricing compression, periodic supply constraints, and formulary dynamics rather than sustained monetization growth from long-lived exclusivities. In most markets, acetylcysteine is widely available, which pressures margins after branded differentiation ends.

Core point: ACETADOTE’s market and financial path follows the economics of an established hospital antidote with multiple manufacturer sources, where demand is recurrent but not expandable through marketing in the same way as specialty therapeutics.

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What market forces shape ACETADOTE demand?

1) Indication concentration and protocol inertia

Acetaminophen overdose is the key demand driver in the U.S. NAC antidote use is protocolized in emergency departments and poison-control pathways. This creates stable baseline utilization but limits upside growth because prescribers follow established dosing algorithms and stock levels.

Net effect: demand is steady rather than growth-catalyzed, so revenue tends to track hospital volume, payer contracting, and unit price.

2) Hospital procurement and contract pricing

Hospital sales for antidotes are dominated by:

• Group purchasing organization (GPO) contracts
• IDN formularies (integrated delivery networks)
• Direct purchasing in high-acuity settings

Net effect: list price is less predictive than contract price and rebate structure. As more suppliers enter, hospitals shift volume to the lowest total cost of acquisition.

3) Generic and alternate-source competition

Acetylcysteine is a mature active ingredient. Once branded exclusivity ends, generic versions and authorized distributors increase competitive intensity. Even when the molecule is the same, unit economics vary by:

• vial/batch costs
• distribution rebates
• supply assurance terms
• shipping and storage constraints

Net effect: pricing pressure and margin compression are common once multiple sources are established.

4) Supply availability as a short-term revenue swing factor

For hospital products, shortages or constrained manufacturing can cause temporary price changes and allocation. Conversely, improved supply from additional manufacturers can push prices down.

Net effect: revenue can show quarter-to-quarter variability from supply conditions rather than from demand expansion.

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How does ACETADOTE compete and what does that do to pricing?

Competitive positioning

“Acetadote” is a branded NAC product. In practice, it competes on:

• formulary access
• contract pricing
• dependable supply
• consistent presentation and concentration used in clinical protocols

Pricing trajectory pattern (typical for mature hospital antidotes)

A mature hospital antidote with multi-source acetylcysteine typically follows a pattern:

• early premium period (when branded supply is preferred and competition is limited)
• mid-period pressure (generic entry and contracting)
• later floor (pricing anchored to generic economics and procurement terms)

Operational implication for investors and R&D partners: growth is usually capped to procurement-driven share changes and occasional supply disruptions, not to durable price uplift.

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What is the likely financial trajectory for ACETADOTE?

Revenue shape

Without relying on a speculative unit-growth story, the financial trajectory for “Acetadote” is most consistent with:

• flat-to-declining revenue after generic/authorized competition expands
• occasional recoveries tied to supply constraints, contract renewals, or temporary allocation

Margin outlook

Hospital antidotes are typically:

• low-margin relative to specialty injectables
• sensitive to manufacturing cost swings and raw material availability
• exposed to price-per-unit erosion over time

So the likely margin path is:

• initially higher gross margin for branded periods
• then compression as ASP or contracted net price falls
• limited ability to offset through marketing spend or patient expansion

Cash flow drivers

Cash flow for a mature antidote brand usually depends on:

• working capital (inventory build during contracting periods)
• logistics costs (cold chain is not generally central for NAC, but delivery reliability matters)
• settlement mechanics (returns, chargebacks, rebates)

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What regulatory and label dynamics influence the market?

FDA label stability

When the label is stable, demand is driven more by clinical practice than by regulatory changes. NAC dosing for acetaminophen overdose is established and widely taught.

Exclusivity and IP

For mature acetylcysteine brands, the key financial swing factor is whether branded exclusivity (or any formulation/manufacturing IP) still supports premium pricing. Once exclusivity expires and generics compete, the brand’s financial trajectory typically becomes a contracting exercise.

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What benchmarks and metrics matter for tracking ACETADOTE performance?

For a hospital antidote, the actionable metrics are:

• ASP vs. contract net price (price erosion indicator)
• Unit volume by quarter (demand vs. share shift)
• GPO and IDN formulary placement (share capture mechanism)
• Supplier count and market availability (supply-induced price variance)
• gross margin trend (manufacturing and rebate pressure)

A typical “mature antidote” signal set looks like:

• volume stable or mildly down
• net price down over time
• margins compressing
• intermittent spikes from shortages or allocation

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Key Takeaways

• ACETADOTE market dynamics are dominated by protocolized hospital use for acetaminophen overdose and procurement-driven contracting, not by specialty-style adoption growth.
• Financial trajectory is typically flat-to-declining revenue with pricing compression once multi-source acetylcysteine competition increases.
• Short-term quarter-to-quarter swings are most often tied to supply conditions and contract renewals, not label expansion.
• The most decision-relevant tracking metrics are contract net pricing, unit volume, formulary placement, gross margin, and supply availability.

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FAQs

1) What drives ACETADOTE demand in the U.S.?

Acetaminophen overdose incidence and hospital/poison-control protocols that standardize NAC antidote use.

2) Does ACETADOTE have the same growth levers as specialty drugs?

No. Growth is constrained by established clinical protocols, hospital procurement cycles, and generic substitution dynamics.

3) What competition pressures ACETADOTE the most?

Authorized and generic acetylcysteine sources that shift purchasing to lower total acquisition cost through GPO and IDN contracting.

4) What explains short-term revenue volatility for ACETADOTE-like products?

Manufacturing availability, allocation, and timing of contract renewals that alter net prices and purchase volumes.

5) Which financial line items matter most when monitoring ACETADOTE?

Net price (ASP-to-contract spread), gross margin, unit volume trends, and rebate/chargeback dynamics tied to hospital buying programs.

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References

1. FDA. “Drug Safety and Availability” and related FDA labeling resources for acetylcysteine/NAC products (accessed via FDA drug databases).
2. FDA. Acetaminophen overdose treatment information and NAC antidote dosing guidance contained in FDA labeling for acetylcysteine products (accessed via FDA labeling).