DAURISMO Drug Patent Profile

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

Daurismo is a drug marketed by Pfizer and is included in one NDA. There are five patents protecting this drug.

This drug has ninety-eight patent family members in fifty countries.

The generic ingredient in DAURISMO is glasdegib maleate. One supplier is listed for this compound. Additional details are available on the glasdegib maleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Daurismo

Daurismo was eligible for patent challenges on November 21, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 13, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DAURISMO

International Patents:	98
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	2
Patent Applications:	249
Drug Prices:	Drug price information for DAURISMO
What excipients (inactive ingredients) are in DAURISMO?	DAURISMO excipients list
DailyMed Link:	DAURISMO at DailyMed

See drug prices for DAURISMO

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

Constraining patent/regulatory exclusivity:

10,414,748

NDA:

210656

Dosage:

TABLET;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.

Recent Clinical Trials for DAURISMO

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

Sponsor	Phase
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1
M.D. Anderson Cancer Center	Phase 1/Phase 2

See all DAURISMO clinical trials

Pharmacology for DAURISMO

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

US Patents and Regulatory Information for DAURISMO

DAURISMO is protected by five US patents.

This potential generic entry date is based on patent 10,414,748.

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
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No	11,168,066
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes	11,891,372
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No	10,414,748		Y	Y

International Patents for DAURISMO

When does loss-of-exclusivity occur for DAURISMO?

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

Argentina

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

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 DAURISMO around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	104391
Australia	2016251940
Brazil	112017021075

Supplementary Protection Certificates for DAURISMO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2170860	301057	Netherlands		PRODUCT NAME: GLASDEGIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, MET INBEGRIP VAN HET MALEAATZOUT; REGISTRATION NO/DATE: EU/1/20/1451/001-004 20200626
2170860	LUC00173	Luxembourg		PRODUCT NAME: GLASDEGIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL DE MALEATE; AUTHORISATION NUMBER AND DATE: EU/1/20/1451 20200629
2170860	132020000000109	Italy		PRODUCT NAME: GLASDEGIB, OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, INCLUSO IL SALE MESILATO(DAURISMO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1451, 20200629

DAURISMO (dasatinib) market dynamics and financial trajectory: sales trend, drivers, exclusivity cliffs, and competitive risks

Last updated: July 22, 2026

DAURISMO revenue has tracked the launch and adoption curve of dasatinib in chronic myeloid leukemia (CML) and Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL), with market share shaped by next-generation kinase inhibitors, dose-formulation shifts, payer behavior, and generic and biosimilar-adjacent competitive pressure. Financial trajectory is structurally constrained by patent/exclusivity expirations and the need to defend against lower-cost entrants across major geographies.

DAURISMO sales trend: how has dasatinib performed financially since launch?

DAURISMO is the brand name for dasatinib, a BCR-ABL tyrosine kinase inhibitor used in CML (including chronic phase, accelerated phase, and blast phase) and Ph+ ALL. Market dynamics for dasatinib are dominated by (1) front-line and later-line treatment positioning versus competing BCR-ABL inhibitors, (2) switching due to tolerability and dosing schedules, (3) reimbursement and contracting dynamics, and (4) the durability of patented dosing/formulations.

Featured-snippet view: Dasatinib’s financial trajectory is driven by sustained CML market penetration early in the TKI cycle, then dampened by competition from newer TKIs and by margin compression from price competition where generics enter.

Key markets and channel structure

• United States: high-cost specialty pharmacy and specialty wholesalers; contracting is outcome- and formulary-driven.
• Europe: national formularies and hospital tenders with more centralized pricing controls.
• Japan and other APAC: label-specific uptake and local payer structures drive realized net price.

What typically moves DAURISMO unit growth

• New guideline adoption for specific dasatinib indications (line of therapy, biomarker-driven eligibility).
• Treatment sequencing decisions after imatinib failure or intolerance.
• Toxicity profile shifts that push patients toward or away from dasatinib versus alternatives (pleural effusion risk is a known differentiator in payer and provider discussions).
• Manufacturer behavior around dose reductions, supportive care protocols, and patient assistance.

What patents and exclusivity protect DAURISMO (dasatinib), and when do rights expire?

The market’s long-term financial path is gated by IP. DAURISMO’s compound and method-of-use protection historically constrained generic entry, but the actionable business question for revenue planning is the timing of (a) composition-of-matter expiration and (b) patent expiry for any later-lived formulation, dosing, or use patents listed in the FDA Orange Book.

Featured-snippet view: For marketed small-molecule brands like dasatinib, generic entry risk is driven by Orange Book-listed patent expiration and any successful Paragraph IV challenge outcomes for filed ANDAs.

Orange Book status and patent-listing mechanics

For DAURISMO, the practical financial impact is determined by:

• Whether Orange Book listings are still active for the specific NDA strength(s).
• Whether a generic filed with a Paragraph IV certification targets those patents.
• Whether any settlement prevents launch until a stated agreed date.

Exclusivity beyond composition-of-matter

Even after composition-of-matter expires, continued revenue can be supported by:

• Method-of-use claims tied to specific patient populations or dosing strategies.
• Formulation or manufacturing process claims.
• Patent estates covering combination regimens, where applicable.

When does DAURISMO lose exclusivity, and how do generic launches change revenue?

Featured-snippet view: Generic entry typically produces step-function margin compression followed by a multi-quarter decline in branded net sales, with the pace depending on (1) whether the market retains “no substitution” prescriber behavior, (2) specialty pharmacy switching behavior, and (3) remaining brand-specific differentiation (contracts, patient support, dosing logistics).

Revenue mechanics around generic entry

• Net sales drop: branded sales often fall quickly after first authorized generic or generic adoption, with residual sales tied to prescriber preference, existing patient continuity, and payer step edits.
• Price erosion: realized net price declines faster in insured channels than cash channels.
• Channel churn: specialty distributors and pharmacy benefit managers shift scripts to lowest-cost covered products.

Market scenario patterns

• Single entrant delay: if the first generic enters later, DAURISMO’s plateau can persist.
• Multiple generic simultaneity: synchronized launches compress branded pricing quickly.
• Authorized generics: reduce branded shelf life more aggressively because they match brand supply continuity.

How strong is the patent estate for DAURISMO versus competing BCR-ABL TKIs?

DAURISMO’s defense strength depends on the breadth of:

• Remaining Orange Book listings by NDA strength.
• Validity and enforcement posture (litigation success rates and injunction history).
• Whether competitors can avoid infringement by design choice (different polymorph, salt form, formulation path, or dosing).

Comparison lens versus peer TKIs

In CML, dasatinib competes with:

• Bosutinib, nilotinib, ponatinib (and other lineage TKIs)
• Sequencing strategies after prior TKI failure
• Tolerability and monitoring workflows that influence brand selection

Financially, patent estate strength matters less for near-term cash flow after generic entry than for:

• preventing ANDA launch for the first waves,
• extending “brand lock-in” with settlements.

Which companies are challenging DAURISMO with ANDAs or Paragraph IV certifications?

The key commercial-financial variable is whether Paragraph IV challenges led to:

• court-imposed launch delays,
• negotiated settlements,
• or successful early launches.

Featured-snippet view: Paragraph IV challenge outcomes determine the timing of generic adoption and the slope of DAURISMO net sales decline. In the TKI segment, generic entry timing frequently aligns with rapid formulary updates and substitution policies.

What DAURISMO formulations and strengths drive market performance?

Dasatinib’s market behavior is tied to:

• tablet strengths (dose flexibility),
• dosing schedules that fit clinical practice,
• and any formulation-specific uptake influenced by prescriber experience.

Formulation-level competitive effects

• If a generic can match strength and release profile, payer substitution accelerates.
• If formulation patents remain enforceable, branded continuity extends beyond compound expiry.

What patent litigation affects DAURISMO (dasatinib), and how does it impact launch timing?

Featured-snippet view: Litigation impacts the financial trajectory by controlling ANDA launch dates. When disputes resolve via settlement, DAURISMO typically loses market share only after the settlement “carve-out” date, not immediately upon patent expiry.

Settlement-driven revenue outcomes

Settlement structures typically:

• set an agreed launch date,
• allocate exclusivity for one generic applicant,
• and define carve-outs for non-infringing strengths or non-targeted patents.

In CML, where treatment continuity is clinically important, even small timing changes can have outsized revenue effects because patients remain on therapy until toxicity, progression, or physician-directed switching.

What is the Orange Book status of DAURISMO today, and what does it imply for generics?

Orange Book status determines:

• whether remaining patents are tied to the specific strengths marketed,
• and whether a generic can certify “not infringed” or “invalid” for those patents.

Featured-snippet view: Active listings with unexpired expiry dates constrain immediate generic entry. Once the last relevant listing expires or is no longer enforceable for the certified claims, generic launch risk increases sharply.

How does DAURISMO compare with competing BCR-ABL TKIs on market dynamics?

Featured-snippet view: In CML, dasatinib’s financial trajectory is sensitive to payer formulary decisions among multiple TKIs. Competition shifts with:

• line-of-therapy preferences,
• toxicity management pathways,
• and perceived clinical performance in specific mutation contexts.

Commercial comparison structure

• Differentiation: tolerability and monitoring requirements.
• Adoption: guideline positioning and physician familiarity.
• Cost: contracting spreads versus generics and competing brands.
• Switching behavior: how often stable patients transition at renewal time.

What generic entry risks exist for DAURISMO (dasatinib), and where are the bottlenecks?

Featured-snippet view: Generic entry risk is highest when Orange Book-listed patents lapse and when Paragraph IV challenges produce settlements or final decisions allowing launch. Bottlenecks include remaining formulation or method-of-use patents that can be asserted to block non-infringing product designs.

Manufacturing and IP barriers

• Process or intermediate claims can slow “authorized” generic readiness.
• If infringement allegations target specific manufacturing steps, launch can be delayed.

Regulatory status: is DAURISMO actively marketed, and what FDA posture matters for growth?

Featured-snippet view: Active FDA approvals and ongoing label maintenance support continued prescribing, while label changes can either expand or constrain addressable usage. Post-approval lifecycle shifts affect how quickly physicians shift from alternative TKIs.

Pathway relevance

As a legacy small-molecule, DAURISMO’s financial growth is limited by:

• maturity of CML treatment markets,
• increased use of newer agents,
• and substitution pressure from low-cost products.

Financial trajectory summary: what the market data usually implies for DAURISMO

DAURISMO’s financial trajectory is shaped by a classic oncology TKI cycle:

1. Launch and scale-up in treatment-naive and post-imatinib settings.
2. Peak adoption driven by clinical guideline fit and competitive differentiation.
3. Subsequent share pressure as newer TKIs expand into preferred sequencing and as payers negotiate lower-cost coverage.
4. Legal and Orange Book-driven generic entry milestones that produce margin compression and revenue decline post-launch.

Key Takeaways

• DAURISMO (dasatinib) market performance is driven by CML and Ph+ ALL adoption dynamics and by payer switching behavior among BCR-ABL TKIs.
• The financial slope is constrained by Orange Book patent status and litigation outcomes that determine generic launch timing.
• Generic entry typically causes rapid net price erosion and branded sales declines, with remaining sales tied to continuity-of-care and payer restrictions.
• Formulation and strength coverage can extend brand continuity if enforceable formulation or method-of-use patents remain.

FAQs

1. How do Orange Book patent expirations for dasatinib translate into ANDA launch dates?
2. What tolerability or monitoring factors influence switching between dasatinib and competing TKIs?
3. Do settlements in Paragraph IV cases typically delay generic entry for all strengths or only specific ones?
4. How does payer contracting across specialty pharmacy affect DAURISMO realized net price after generic launches?
5. What drives DAURISMO residual demand after generics enter (continuity, formularies, or step edits)?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-07-22).
2. FDA. Drug Approval Reports / Labeling for DAURISMO (dasatinib). (Accessed 2026-07-22).

DrugChatter Q&A for DAURISMO

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