ACTHAR Drug Patent Profile

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Which patents cover Acthar, and when can generic versions of Acthar launch?

Acthar is a drug marketed by Sanofi Aventis Us and Mallinckrodt Ireland and is included in two NDAs. There is one patent protecting this drug.

The generic ingredient in ACTHAR is corticotropin. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the corticotropin profile page.

DrugPatentWatch^® Generic Entry Outlook for Acthar

Indicators of Generic Entry

Summary for ACTHAR

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	78
Patent Applications:	1,267
What excipients (inactive ingredients) are in ACTHAR?	ACTHAR excipients list
DailyMed Link:	ACTHAR at DailyMed

Recent Clinical Trials for ACTHAR

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

Sponsor	Phase
Toyos Clinic	PHASE4
University of North Carolina, Chapel Hill	Phase 4
University of California, San Francisco	Phase 4

See all ACTHAR clinical trials

US Patents and Regulatory Information for ACTHAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	ACTHAR	corticotropin	INJECTABLE;INJECTION	007504-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt Ireland	ACTHAR GEL (AUTOINJECTOR)	corticotropin	INJECTABLE;INJECTION	008372-003	Feb 29, 2024		RX	Yes	Yes	11,752,199
Mallinckrodt Ireland	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372-008	Approved Prior to Jan 1, 1982		RX	Yes	Yes	11,752,199
Sanofi Aventis Us	ACTHAR	corticotropin	INJECTABLE;INJECTION	007504-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt Ireland	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt Ireland	ACTHAR GEL (AUTOINJECTOR)	corticotropin	INJECTABLE;INJECTION	008372-004	Feb 29, 2024		RX	Yes	Yes	11,752,199

ACTHAR Market Dynamics, Financial Trajectory, Patent Protection and Generic Entry Risk

Last updated: November 1, 2026

Acthar Gel is a high-priced repository corticotropin injection marketed by Mallinckrodt Pharmaceuticals. Its commercial profile has shifted from rapid revenue expansion to erosion driven by payer restrictions, reimbursement scrutiny, competing corticotropin products and Mallinckrodt’s financial restructuring. Acthar remains protected primarily by regulatory complexity, manufacturing know-how and clinical-use barriers rather than a clear, near-term composition-of-matter patent cliff.

What is Acthar Gel and how is it regulated?

Acthar Gel is repository corticotropin injection, a complex porcine-derived product containing adrenocorticotropic hormone activity. It is administered by subcutaneous or intramuscular injection. The product is marketed under FDA NDA 011372 and has approval across several indications, including:

• Infantile spasms in infants and children younger than two years
• Acute exacerbations of multiple sclerosis
• Rheumatic disorders
• Severe erythema multiforme and Stevens-Johnson syndrome
• Serum sickness
• Nephrotic syndrome
• Severe acute and chronic allergic and inflammatory conditions
• Ophthalmic, respiratory and edematous disorders

The current FDA label contains broad historical indications inherited from the product’s original approval history. Acthar was first approved in 1952, before the modern NDA system. Its age limits the relevance of conventional new-drug exclusivity analysis, but it does not eliminate commercial barriers to competition.[1]

Is Acthar a biologic or a conventional pharmaceutical?

Acthar is regulated as a drug rather than as a modern biologic licensed under a biologics license application. Its active material is a complex biological-derived mixture rather than a single, synthetically defined small molecule. That distinction matters because a potential competitor cannot rely on a simple ANDA pathway in the same way that a generic manufacturer can for a conventional tablet.

The product’s source material, purification process, potency testing, formulation and clinical evidence create barriers for competitors. Those barriers do not amount to permanent exclusivity. They increase development cost and regulatory risk.

How has Acthar revenue changed?

Acthar remains Mallinckrodt’s main commercial asset, but revenue has declined from its peak as payers tightened utilization controls and competing repository corticotropin products entered the market.

Period	Acthar commercial trend	Primary drivers
2014-2017	Rapid growth and peak pricing	Questcor acquisition, price increases, expanded specialist use
2018-2020	Stabilization at approximately $1 billion annually	Payer controls offset by chronic specialist demand
2021	Moderate decline	Reimbursement pressure and access restrictions
2022	Further decline	Medicaid and commercial payer scrutiny, utilization management
2023	Continued erosion	Competitive pressure from Cortrophin Gel and Mallinckrodt restructuring
2024 onward	Higher risk of volatility	Ownership restructuring, payer negotiations and competitor uptake

Mallinckrodt’s public filings show Acthar net sales declining from roughly $1.0 billion-plus annually in the late 2010s and early 2020s to materially lower levels by 2023.[2] The exact annual result depends on the company’s reporting period and product classification, but the direction is consistent: Acthar is a large cash-generating product with a shrinking revenue base.

The decline is commercially important because Acthar has historically contributed a disproportionate share of Mallinckrodt’s operating cash flow. A 10% change in Acthar revenue has a larger effect on Mallinckrodt’s earnings profile than the same percentage change in a diversified pharmaceutical portfolio.

Why has Acthar revenue declined?

Four factors have shaped the trajectory.

First, Acthar’s price and utilization became central payer-management targets. Commercial insurers, Medicare contractors and Medicaid programs have imposed prior authorization, step-therapy and specialist-prescribing requirements.

Second, the product’s clinical positioning has faced scrutiny. Payers have challenged whether Acthar provides sufficient incremental value compared with corticosteroids or other established treatments in several indications.

Third, the market has absorbed litigation and government-reimbursement risk. Mallinckrodt disclosed substantial legal and regulatory liabilities associated with Acthar marketing, reimbursement and Medicaid pricing practices.[2][3]

Fourth, ANI Pharmaceuticals introduced Cortrophin Gel, a competing repository corticotropin product, after FDA approval in 2021. Cortrophin created an alternative for prescribers and payers that had previously faced a largely single-source market.[4]

What is the competitive landscape for Acthar?

The main branded competitor is Cortrophin Gel, marketed by ANI Pharmaceuticals. It is not a conventional generic substitution for Acthar. Its commercial strategy is based on separate FDA approval, differentiated contracting and physician adoption.

Product	Company	Active product type	FDA status	Competitive position
Acthar Gel	Mallinckrodt	Repository corticotropin injection	Approved under NDA 011372	Incumbent product with broad historical labeling
Cortrophin Gel	ANI Pharmaceuticals	Repository corticotropin injection	Approved in 2021	Branded challenger with commercial launch
Corticosteroids	Multiple companies	Synthetic anti-inflammatory drugs	Broadly approved	Lower-cost therapeutic alternatives
Immunosuppressive therapies	Multiple companies	Small molecules and biologics	Indication-specific	Substitute therapies in inflammatory and autoimmune disease

Corticosteroids are the most important economic substitute. In nephrotic syndrome, multiple sclerosis exacerbations and inflammatory disorders, physicians may consider steroids or other immunomodulators before requesting Acthar. The relevant competitive question is therefore broader than whether a generic Acthar product appears.

How does Acthar compare with Cortrophin Gel?

Acthar has longer commercial history, broader historical labeling and established physician familiarity. Cortrophin has the potential to compete through price, payer contracting and targeted specialty promotion.

The competitive balance depends on:

• Formulary placement
• Prior-authorization criteria
• Net price after rebates
• Availability of patient-assistance programs
• Published clinical evidence
• Physician experience
• Distribution and specialty-pharmacy access

Cortrophin’s approval reduces Acthar’s practical exclusivity even without an Acthar generic. Its market impact is likely to be greatest in indications where payers view the products as clinically substitutable.

What patents protect Acthar?

Acthar’s commercial protection is not based on a clearly defined, long-duration composition-of-matter patent comparable to a recently approved small-molecule drug. The original product is decades old, and any original patent rights have expired.

The relevant protection layers are more likely to involve:

1. Manufacturing and purification processes
2. Product characterization
3. Formulation and stability
4. Dosing regimens
5. Method-of-use claims
6. Trade secrets and quality-control procedures
7. Regulatory exclusivity linked to specific indications

Publicly available FDA materials identify Acthar under NDA 011372, but the product does not present the typical Orange Book patent profile of a modern drug with a predictable loss-of-exclusivity date.[1][5]

What formulations are protected by Acthar patents?

The commercial formulation is a gelatin-based repository injection. Potential formulation claims may cover concentration, excipients, stability, delivery and storage conditions. Such claims would be narrower than a composition-of-matter patent and would not necessarily block development of a different repository corticotropin formulation.

For a competitor, the primary risk is not only patent infringement. It is the need to demonstrate that a new product has appropriate identity, strength, quality, purity, potency and clinical performance. A non-infringing product may still require extensive development work.

Are there active Orange Book patents for Acthar?

Acthar does not have the same type of well-known Orange Book patent barrier associated with products such as insulin analogs, inhaled drugs or newer specialty medicines. The FDA Orange Book should be reviewed for current listing status before any filing strategy, because listings can change and the regulatory consequences depend on the specific NDA and proposed pathway.[5]

The absence of a major listed patent does not mean immediate generic entry. It means the central barrier has shifted from patent duration to product complexity, regulatory classification, evidence requirements and manufacturing capability.

When does Acthar lose exclusivity?

Acthar’s original statutory exclusivity expired long ago. Its orphan-drug designation for infantile spasms provided a seven-year period of orphan exclusivity beginning after the relevant approval, but that period also expired years ago.[1]

Acthar therefore has no single future patent-expiration date that defines market entry. The practical exclusivity timeline is determined by:

• FDA acceptance of a competing application
• The regulatory pathway selected by the competitor
• Clinical and analytical comparability requirements
• Manufacturing validation
• Patent litigation, if applicable
• Payer acceptance of the entrant

This is a key difference from a newly approved orphan drug with seven years of remaining orphan exclusivity or a small molecule with an unexpired composition patent.

What generic entry risks exist for Acthar?

The probability of a conventional ANDA launch is lower than for a chemically defined injectable. A competitor may instead pursue a 505(b)(2) application or another application supported by a combination of published data, bridging studies and new clinical evidence.

What would a generic Acthar launch require?

A credible entrant would need to address:

• Source and identity of the active material
• Potency and biological activity
• Impurity profile
• Batch-to-batch consistency
• Sterility and injectable quality
• Stability and storage
• Pharmacologic comparability
• Indication-specific clinical support
• Commercial distribution and reimbursement

A successful entrant could erode Acthar revenue without being automatically substitutable at the pharmacy counter. Physician prescribing and payer authorization would remain important.

What would a generic launch do to pricing?

The effect would depend on whether the entrant receives automatic substitution status and whether payers recognize it as therapeutically interchangeable. A branded competitor generally produces slower price erosion than an ANDA generic.

A true generic or therapeutically interchangeable product could compress net price sharply. A second branded product is more likely to reduce Acthar’s share while preserving a higher industry price level.

Which companies are challenging Acthar?

ANI Pharmaceuticals is the principal direct branded challenger through Cortrophin Gel.[4] Other competitive pressure comes from manufacturers of corticosteroids, immunosuppressants and biologic therapies used in overlapping disease areas.

The competitive set includes:

• ANI Pharmaceuticals
• Generic corticosteroid manufacturers
• Specialty pharmaceutical companies selling immunosuppressants
• Biopharmaceutical companies developing treatments for nephrotic syndrome and autoimmune disease
• Hospital and specialty pharmacies that influence product selection

The market is therefore exposed to both product-level competition and therapeutic substitution.

What patent litigation and regulatory litigation affect Acthar?

Acthar has faced legal and regulatory pressure on several fronts.

Government reimbursement and marketing matters

Mallinckrodt disclosed settlements and legal proceedings involving Acthar promotion, reimbursement and Medicaid-related obligations. The company’s liabilities included a major settlement with U.S. authorities and states concerning Acthar-related claims and reimbursement practices.[2][3]

These matters affect the asset in three ways:

• Direct cash payments reduce product-level returns.
• Compliance obligations can restrict promotion and reimbursement practices.
• Payer scrutiny can persist after formal settlement.

Pricing litigation and public scrutiny

Acthar’s price history has drawn congressional, payer and public scrutiny. The product’s historical price increases became part of the broader debate over specialty-drug pricing and government reimbursement. That scrutiny raises the risk that future price increases will produce limited incremental revenue and greater payer resistance.

Patent litigation

No single active patent dispute currently defines Acthar’s market outlook in the way that patent litigation defines several major branded drugs. The principal litigation risk for a future entrant would arise if Mallinckrodt asserted formulation, manufacturing or method-of-use patents after a regulatory filing.

What is Acthar’s FDA and Orange Book status?

Acthar is an FDA-approved prescription product under NDA 011372. Its regulatory status is unusual because the product originated before the modern generic-drug framework and has a complex biological-derived composition.[1]

The FDA pathway for a competitor would depend on the extent to which the applicant can establish sameness or rely on prior findings of safety and effectiveness. A 505(b)(2) strategy is more plausible than a simple ANDA strategy if the applicant’s product differs materially in source, formulation or manufacturing.

The Orange Book remains relevant for patent certification and regulatory exclusivity analysis. It is not, by itself, a complete measure of Acthar’s market defensibility.

How strong is the Acthar patent estate?

Acthar’s patent estate is moderate to weak as a conventional exclusivity asset but stronger as an integrated manufacturing and regulatory asset.

Protection category	Relative strength	Commercial relevance
Original composition patents	Low	Expired due to product age
Orange Book patent barrier	Limited compared with newer drugs	May not prevent all entry
Manufacturing know-how	High	Difficult to reproduce consistently
Product characterization	High	Important for regulatory approval
Historical clinical database	Moderate	Supports labeling and physician confidence
Method-of-use patents	Variable	Depends on claim scope and expiration
Orphan exclusivity	Expired	No current broad protection
Brand and distribution	Moderate	Supports retention but does not block entry

The strongest barriers are operational. Mallinckrodt’s ability to produce a consistent product and maintain regulatory compliance has more practical value than an expired primary patent.

How does Acthar affect Mallinckrodt’s financial trajectory?

Acthar is central to Mallinckrodt’s credit and restructuring profile. Declining Acthar sales reduce cash available for debt service, litigation payments, research investment and commercial infrastructure.

Mallinckrodt completed a court-supervised restructuring in 2022 and later entered another restructuring process before emerging again in 2024. The company’s capital structure has been closely tied to expected Acthar cash flows.[2]

The financial sensitivity can be summarized as follows:

Risk factor	Effect on Acthar economics
Payer prior authorization	Reduces approved patient volume
Lower reimbursement	Compresses net price
Cortrophin adoption	Reduces market share
Government settlement obligations	Reduces free cash flow
Manufacturing interruption	Creates high revenue concentration risk
New competitor approval	Weakens practical exclusivity
Label expansion	Could restore growth if clinically and economically accepted

Acthar remains valuable because it has established demand and no dominant low-cost generic. Its risk profile is higher than its revenue scale suggests because Mallinckrodt depends heavily on one mature product.

What licensing deals affect Acthar?

The major strategic transaction shaping Acthar was Mallinckrodt’s acquisition of Questcor Pharmaceuticals in 2014. The transaction transferred Acthar to Mallinckrodt and made the product the center of Mallinckrodt’s specialty-pharmaceutical strategy.[6]

Acthar’s commercial future is more likely to be influenced by asset sales, licensing arrangements, co-promotion or restructuring transactions than by traditional early-stage licensing. Any transaction would need to account for:

• Declining but substantial product revenue
• Medicaid and commercial payer exposure
• Government-settlement obligations
• Manufacturing continuity
• Competing repository corticotropin products
• The absence of a simple patent cliff

What are the likely Acthar launch scenarios?

Scenario 1: Continued branded erosion

Acthar loses share gradually to Cortrophin and therapeutic alternatives. Revenue declines at a controlled rate, while Mallinckrodt preserves cash flow through pricing discipline and cost reductions.

Scenario 2: Accelerated payer displacement

Large payers impose stricter criteria or prefer Cortrophin. Acthar’s approval volume falls faster than its list price, producing a sharper revenue decline.

Scenario 3: Generic or 505(b)(2) entry

A new competitor obtains FDA approval and demonstrates sufficient comparability for broad payer coverage. Net prices fall, and Acthar loses both share and negotiating leverage.

Scenario 4: Stabilization through contracting

Mallinckrodt improves net pricing, retains priority indications and limits competitor access through payer contracts. Revenue stabilizes below historical peaks but remains material.

Key Takeaways

• Acthar is an old, complex repository corticotropin injection marketed by Mallinckrodt.
• Its revenue has declined from roughly $1 billion-plus annual levels as payer controls and competition increased.
• Cortrophin Gel from ANI Pharmaceuticals is the principal direct branded challenger.
• Acthar has no obvious modern composition-of-matter patent cliff driving the market calendar.
• The practical barriers are manufacturing complexity, regulatory evidence, product characterization and reimbursement access.
• Orphan exclusivity and original product protection have expired.
• A conventional ANDA generic is less straightforward than for a chemically defined drug.
• Mallinckrodt’s restructuring history increases the financial importance of Acthar cash flow.
• A 505(b)(2) entrant or a therapeutically substitutable corticotropin product presents greater near-term risk than a classic pharmacy generic.
• The most important commercial variables are payer coverage, net price, Cortrophin adoption and manufacturing continuity.

Frequently Asked Questions

Is Acthar Gel still patent protected?

Acthar is not protected by the type of long-duration composition patent typically associated with a newly approved drug. Any remaining protection is more likely to involve formulation, manufacturing or method-of-use claims.

Can a generic company make Acthar Gel?

A competitor may be able to develop a similar repository corticotropin product, but the regulatory pathway is more complicated than a standard ANDA because Acthar is a complex biological-derived product.

Is Cortrophin Gel interchangeable with Acthar?

Cortrophin Gel is a competing FDA-approved product, not automatically a generic substitute for Acthar. Interchangeability and payer substitution depend on FDA status, state law, formulary policy and individual payer rules.

What is the biggest financial risk to Mallinckrodt from Acthar?

The largest risk is continued erosion of Acthar sales because the product supplies a substantial portion of Mallinckrodt’s commercial cash flow. Lower sales weaken debt service capacity and reduce flexibility during restructuring.

Does Acthar have orphan-drug exclusivity today?

No. Any orphan exclusivity associated with its infantile-spasms approval expired years ago. Acthar’s current market position depends on product complexity, clinical history, manufacturing capability and payer access.

References

1. U.S. Food and Drug Administration. (2024). Acthar Gel prescribing information, NDA 011372. FDA Drugs@FDA.

2. Mallinckrodt plc. (2024). Annual report and Form 10-K for the fiscal year ended December 29, 2023. U.S. Securities and Exchange Commission.

3. U.S. Department of Justice. (2022). Mallinckrodt subsidiary agrees to pay more than $230 million to resolve claims related to Acthar Gel. U.S. Department of Justice.

4. ANI Pharmaceuticals, Inc. (2024). Annual report and Form 10-K. U.S. Securities and Exchange Commission.

5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA.

6. Mallinckrodt plc. (2014). Mallinckrodt completes acquisition of Questcor Pharmaceuticals. Company transaction announcement.

DrugChatter Q&A for ACTHAR

Acthar generic?