ALIQOPA Drug Patent Profile

When do Aliqopa patents expire, and when can generic versions of Aliqopa launch?

Aliqopa is a drug marketed by Bayer Healthcare and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and five patent family members in forty-eight countries.

The generic ingredient in ALIQOPA is copanlisib dihydrochloride. Additional details are available on the copanlisib dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Aliqopa

Aliqopa was eligible for patent challenges on September 14, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 22, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ALIQOPA

International Patents:	105
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	16
Drug Prices:	Drug price information for ALIQOPA
What excipients (inactive ingredients) are in ALIQOPA?	ALIQOPA excipients list
DailyMed Link:	ALIQOPA at DailyMed

See drug prices for ALIQOPA

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

NDA:

209936

Dosage:

POWDER;INTRAVENOUS

^*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.

Recent Clinical Trials for ALIQOPA

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

Sponsor	Phase
NRG Oncology	Phase 2
City of Hope Medical Center	Phase 1/Phase 2
Dana-Farber Cancer Institute	Phase 1/Phase 2

See all ALIQOPA clinical trials

US Patents and Regulatory Information for ALIQOPA

ALIQOPA is protected by three US patents.

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
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No			Y	Y
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No			Y	Y

Expired US Patents for ALIQOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017

International Patents for ALIQOPA

When does loss-of-exclusivity occur for ALIQOPA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Guatemala

Honduras

Hong Kong

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

Morocco

New Zealand

Norway

Panama

Peru

Poland

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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

See the table below for additional patents covering ALIQOPA around the world.

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3709
Argentina	085718
Australia	2012238891
Brazil	112013025549
Canada	2832123
Chile	2013002870
China	103649091

Last updated: June 28, 2026

ALIQOPA (copanlisib) Market Dynamics and Financial Trajectory: Sales Mix, Growth Drivers, and Generic- and Biosimilar-Exclusivity Risks

Executive summary: Aliqopa (copanlisib) is an oncology small-molecule PI3K inhibitor with a constrained, niche commercialization profile in the U.S. and select markets, driven by limited line-of-therapy penetration in follicular lymphoma (FL) and marginal expansion in subsequent indications. The product’s near-term financial trajectory is determined by (1) payer and physician adoption hurdles tied to toxicity management and treatment sequencing, (2) competition from PI3K class alternatives and evolving FL standards (BTK and other targeted regimens), and (3) time-bound IP and regulatory exclusivity dynamics that gate generic entry and expand cost-based pressure as exclusivity wanes.

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What is the sales trajectory of Aliqopa (copanlisib) and how has revenue changed over time?

Aliqopa’s revenue trajectory has historically reflected a “launch-to-niche plateau” pattern common to oncology drugs with safety monitoring burdens and a narrow indication footprint. Market adoption has been tempered by:

• Treatment sequencing: FL care increasingly shifts toward earlier use of regimens that compete for eligible patients.
• Toxicity management: copanlisib’s adverse event profile (notably hyperglycemia and hypertension class effects) increases the operational friction for routine use.
• Comparator strength: PI3K inhibitors face class-by-class competitive pressure, while the broader FL market increasingly incorporates regimens outside the PI3K class.

Featured snippet:

• Aliqopa’s financial trajectory is best characterized as stable-to-declining growth after early uptake, with limited expansion beyond its core FL use cases.

Key financial drivers to track in Aliqopa performance

• Net price and rebates: PI3K inhibitors typically face rebate pressure as formularies consolidate.
• Channel mix: specialty pharmacy distribution tends to concentrate revenue into fewer large accounts, amplifying payer policy shifts.
• Duration of therapy: real-world persistence shortens when toxicity affects dose intensity.

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What market dynamics shape Aliqopa adoption in follicular lymphoma (FL) and other cancers?

Which payer and formulary factors affect Aliqopa (copanlisib) uptake?

• Prior authorization: common for oncology drugs in later lines.
• Step edits and regimen restrictions: payers favor evidence aligned with guideline sequencing.
• Budget impact thresholds: PI3K inhibitors can trigger plan-specific restrictions due to high monthly costs.

How does toxicity impact real-world utilization?

• Monitoring burden: frequent glucose and blood pressure checks increase clinic utilization costs.
• Dose interruptions and discontinuations: can shorten treatment duration and reduce effective revenue per patient.

How does clinical positioning influence physician adoption?

• Adoption correlates with clear comparative benefit versus available targeted options in FL lines where copanlisib is still clinically relevant.

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How does Aliqopa (copanlisib) compete with other PI3K inhibitors and targeted therapies in FL?

What are the main competitive threats to Aliqopa?

• PI3K inhibitor peers: other PI3K inhibitors with different dosing schedules and safety profiles.
• Targeted FL regimens outside PI3K: BTK inhibitors and other targeted combinations that may displace late-line PI3K use.
• Evolving standards of care: if the therapeutic goal shifts earlier in the disease course, copanlisib’s remaining addressable population can shrink.

How does class competition affect net pricing?

• Competition forces formulary placements into narrower tiers and increases rebating pressure, particularly where multiple oncology agents target overlapping endpoints.

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When does Aliqopa’s exclusivity end, and how does it affect generic entry risk?

Featured snippet:

• Generic entry timing depends on Orange Book-listed exclusivities (U.S.) and patent estate expiry, with Paragraph IV risk rising as exclusivity and key composition claims approach end dates.

What exclusivity categories commonly matter for small-molecule oncology drugs like Aliqopa?

• New Chemical Entity (NCE) exclusivity (if applicable): typically 5 years from approval.
• Orphan Drug exclusivity (if applicable): typically 7 years from approval for the designated indication.
• Patent expiration: composition and method claims drive real-world generic launch feasibility.
• Regulatory exclusivity extensions: pediatric exclusivity or supplemental exclusivity can shift practical entry windows.

Why exclusivity does not equal sales protection

Even before hard exclusivity expiration, commercialization can erode due to:

• payer formulary re-tiering,
• channel inventory tightening,
• switching to preferred regimens,
• off-formulary substitutions at the margin.

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What patents protect Aliqopa (copanlisib) and how strong is the estate for blocking generics?

Featured snippet:

• Aliqopa’s generic blocking strength is driven by Orange Book composition-of-matter patents and, secondarily, formulation and method-of-use claims tied to the approved dosing and indication.

Patent estate components typically relevant to copanlisib

• Composition-of-matter: core chemical entity claims.
• Method of treatment: claims tied to FL dosing regimens.
• Formulation and manufacturing: process claims can complicate “skinny” generic approaches if they are covered by additional Orange Book listings.

What litigation posture changes generic incentives?

• Patent litigation settlements can shift launch timing even when exclusivity remains.
• If courts narrow claim scope, generic leverage increases near expiration.

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What generic entry risks exist for Aliqopa (copanlisib) in the U.S.?

Paragraph IV framework for an oncology small molecule

• Generics file Paragraph IV certifications to challenge at least one listed patent.
• A successful challenge triggers an entry timeline under the Hatch-Waxman regime, often constrained by automatic stay mechanics.

What factors increase Paragraph IV likelihood?

• multiple expiring patents near the same period,
• clearly invalidity arguments (or narrowed claim construction in similar cases),
• high sales volumes that justify litigation and launch spend.

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What biosimilar risk exists for Aliqopa (copanlisib)?

Featured snippet:

• Biosimilar risk is not applicable because Aliqopa is a small molecule, not a biologic.

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What is the Orange Book status of Aliqopa (copanlisib) and which patents are most material?

Aliqopa’s U.S. IP posture is determined by the Orange Book listing set, including:

• patent numbers with expiration dates,
• exclusivity codes linked to approval history,
• any listed periods tied to manufacturing or method claims.

Materiality ranking (how to think about it in practice):

1. composition-of-matter patents with the latest expiration,
2. formulation or method patents that restrict design-around,
3. secondary patents that may fall earlier but still trigger Paragraph IV litigation.

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How does Aliqopa’s regulatory pathway influence its market access and revenue?

What FDA label scope drives reimbursement eligibility?

Revenue tends to track:

• label wording tightness,
• biomarker or line-of-therapy limitations,
• duration-of-treatment guidance that affects payer coverage.

What matters for post-approval expansion?

• If post-approval studies expand indications or strengthen efficacy in earlier lines, addressable market expands.
• If studies do not extend label breadth or show reduced comparative value, growth remains capped.

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How do distribution, pricing, and net-to-gross margins impact Aliqopa financial performance?

Net pricing pressure mechanisms in oncology

• Rebates and discounts rise as competition intensifies or when payers seek parity across class alternatives.
• Specialty pharmacy execution affects fill rates and time-to-therapy.

Market access “levers” that typically swing monthly revenue

• formulary positioning within the oncology tier,
• patient assistance program (PAP) coverage policies,
• payer coverage criteria and prior authorization turnaround time.

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How does Aliqopa (copanlisib) compare with competing PI3K inhibitors on commercial trajectory?

Featured snippet:

• Comparable PI3K inhibitors show that commercial sustainability depends more on payer access and tolerability management than on efficacy alone.

Commercial comparison dimensions to use for Aliqopa vs peers

• dosing schedule convenience (frequency affects adherence and administration cost),
• safety management protocols (hospital/clinic monitoring intensity),
• breadth of label and real-world patient funnel size,
• negotiated net price trajectory.

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What manufacturing and IP barriers can delay generic entry for Aliqopa (copanlisib)?

Even where patent expiry occurs, practical launch depends on:

• ability to source copanlisib and scale formulation,
• regulatory CMC readiness aligned to FDA requirements,
• design-around constraints if formulation or method patents persist.

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What litigation affects Aliqopa (copanlisib) market timing and licensing deals?

Featured snippet:

• Litigation and settlements influence launch timing more than headlines about “approaching expiration.”

Patent litigation levers that shift financial outcomes

• automatic stay triggered by Paragraph IV actions,
• district court claim construction outcomes,
• appellate reversals narrowing the patent landscape.

Licensing dynamics

• settlements can include milestone payments or launch date commitments that change the effective competitive entry timeline.

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Key Takeaways

• Market dynamics: Aliqopa’s commercial trajectory is driven by limited addressable patient funnel, payer access friction, and toxicity management burdens that reduce persistence and constrain adoption.
• Competitive landscape: PI3K class competition and shifting FL standards pressure net pricing and restrict broad use.
• Exclusivity and entry risk: Generic entry risk increases as Orange Book exclusivities and key composition or method patents approach end dates, but practical timing can shift based on Paragraph IV litigation and settlements.
• No biosimilar risk: Aliqopa is a small molecule and does not face biosimilar competition.

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FAQs

1) What factors most determine real-world persistence for Aliqopa (copanlisib)?
Toxicity-driven dose interruptions, monitoring burden, and payer authorization continuity.

2) Does Aliqopa’s revenue depend more on net price or patient volume?
In practice, both matter, but payer policies and formulary placement often swing net price, while label scope and sequencing drive patient volume.

3) How do prior authorization requirements affect time-to-therapy for Aliqopa?
They slow initiation and can reduce the conversion rate from eligible patients to treated patients.

4) Are there higher-risk periods for formulary downgrades for PI3K inhibitors like Aliqopa?
Typically around when competing agents secure broader coverage, when patent leverage weakens, or when budget-rebate targets tighten.

5) What would signal a meaningful change in Aliqopa’s financial outlook?
An expansion of label scope, improved tolerability data that alters practice patterns, or a settlement/litigation outcome that shifts generic entry timing.

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. Hatch-Waxman Act. (n.d.). Hatch-Waxman framework for ANDA and Paragraph IV certifications. U.S. Congress. https://www.law.cornell.edu/wex/hatch_waxman_act