CAPRELSA Drug Patent Profile

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

Caprelsa is a drug marketed by Genzyme Corp and is included in one NDA. There is one patent protecting this drug.

This drug has forty patent family members in thirty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Caprelsa

Caprelsa was eligible for patent challenges on April 6, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 8, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CAPRELSA

International Patents:	40
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	17
Drug Prices:	Drug price information for CAPRELSA
What excipients (inactive ingredients) are in CAPRELSA?	CAPRELSA excipients list
DailyMed Link:	CAPRELSA at DailyMed

See drug prices for CAPRELSA

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

Constraining patent/regulatory exclusivity:

8,067,427

NDA:

022405

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 CAPRELSA

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

Sponsor	Phase
AstraZeneca	Phase 2
Samsung Medical Center	Phase 2
Cancer Research UK	Phase 1

See all CAPRELSA clinical trials

Pharmacology for CAPRELSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors Protein Kinase Inhibitors

US Patents and Regulatory Information for CAPRELSA

CAPRELSA is protected by one US patents.

This potential generic entry date is based on patent 8,067,427.

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
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	8,067,427		Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011		RX	Yes	Yes	8,067,427		Y

Expired US Patents for CAPRELSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011	7,173,038
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011	6,414,148
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011	8,642,608

EU/EMA Drug Approvals for CAPRELSA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi B.V.	Caprelsa	vandetanib	EMEA/H/C/002315Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.Caprelsa is indicated in adults, children and adolescents aged 5 years and older.For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.	Authorised	no	no	no	2012-02-16

International Patents for CAPRELSA

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

Country	Patent Number	Title	Estimated Expiration
Austria	228114
Australia	4561397
Australia	729968

Supplementary Protection Certificates for CAPRELSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1244647	C300543	Netherlands		PRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
1244647	PA2012015	Lithuania		PRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 20120217
1244647	CA 2012 00032	Denmark

Last updated: July 29, 2026

Caprelsa (capmatinib) Market Dynamics and Financial Trajectory: Exclusivity, Competition, and Revenue Outlook

Caprelsa (capmatinib) is a branded oncology therapy that competes in a crowded EGFR/ALK inhibitor landscape, with market outcomes driven by (1) the cadence of new-generation targeted inhibitors, (2) line-of-therapy migration, and (3) the size and durability of the biomarker-defined patient segment. Financial trajectory is also shaped by patent and exclusivity constraints that govern generic and biosimilar risk, plus payor coverage shifts as newer agents expand across EGFR mutation and resistance subtypes.

What is Caprelsa (capmatinib) and where does it fit in the oncology treatment pathway?

Caprelsa is a targeted cancer drug used in defined genetic subsets. Market uptake tends to correlate with biomarker testing penetration, clinician familiarity, and evidence strength relative to competing TKIs. Revenue trajectory for branded TKIs typically hinges on two levers: (i) whether the drug maintains a durable position in the first-line and later-line settings as new entrants arrive, and (ii) whether payors tighten step edits as competing alternatives offer improved efficacy, toxicity profiles, or convenience.

Which cancers and biomarkers drive Caprelsa demand?

Demand typically depends on how Caprelsa is positioned in clinical guidelines and label-specific eligibility, including:

• Biomarker prevalence in diagnosed populations
• Evidence strength in progression-free and overall survival endpoints versus comparators
• Sequencing rules based on resistance patterns and prior lines of therapy
• Clinician adoption and real-world persistence

How does Caprelsa compare with competing targeted therapies?

In EGFR/ALK-adjacent oncology markets, branded revenue trajectories usually reflect relative differentiation across:

• Efficacy by mutation subtype
• CNS penetration and resistance mechanisms
• Toxicity management burden
• Dosing schedule and patient adherence

What patents protect Caprelsa and how strong is the patent estate for business planning?

Branded drug financial outcomes are constrained by patent expiration schedules and the breadth of Orange Book-listed exclusivities and patent claims covering formulations, methods, and specific uses. For Caprelsa, business risk is primarily driven by:

• Composition-of-matter and method-of-use patent lifetimes
• Whether process or salt/formulation patents add delay
• Whether Paragraph IV challenges lead to earlier-than-expected generic entry

How many Orange Book listings exist for Caprelsa and what do they cover?

Orange Book coverage is the operational proxy for generic entry risk. The relevant categories are:

• Drug substance patents (composition, salts)
• Drug product patents (formulation, dosage form)
• Method-of-use patents (indications, dosing regimens)

When do Caprelsa patents and exclusivities expire?

The generic-risk timeline is set by the earliest of:

• Patent expiration (including terminal disclaimers)
• Regulatory exclusivity expiration (New Chemical Entity exclusivity, orphan exclusivity, pediatric exclusivity if applicable)
• Any FDA approvals that change exclusivity status (line extension does not necessarily extend core exclusivity, but can change Orange Book landscape)

When does Caprelsa lose exclusivity and what generic entry risks exist?

Generic entry risk is typically stepwise: filing of an ANDA triggers potential Paragraph IV litigation; settlement can bring launch timing forward or back; absent litigation, approval can occur on a tight schedule after exclusivity/patent expiry.

What Paragraph IV challenges are expected for Caprelsa?

The first sign is typically ANDA filings with certifications (Paragraph IV) against Orange Book patents. Business impact depends on:

• Number and strength of asserted patents
• Whether settlements include “carve-outs” or narrow launch triggers
• Whether the generic is launch-ready or requires design-around reformulation

What launch scenarios can affect Caprelsa revenue?

Revenue step-down commonly comes from one of these scenarios:

• At-launch price erosion: entry at scale compresses net price quickly
• Delayed entry: litigation or settlement delays approval, sustaining brand share
• Partial launch design-around: narrower label may limit near-term substitution

How does Caprelsa financial trajectory change under payor pressure and tendering?

For branded oncology drugs, net revenue is shaped more by reimbursement mechanics than list price alone:

• Managed-entry agreements and rebates
• Formulary placement and prior authorization criteria
• Step therapy adoption as newer competitors reach preferred status
• Tender dynamics for certain regions and hospital procurement models

What payor behaviors typically precede revenue declines for branded TKIs?

• Preferencing of next-generation agents with superior efficacy or tolerability
• Hardening of clinical criteria for continuation therapy
• Increased use of biomarkers requiring additional testing steps

Which companies are challenging Caprelsa and how could that reshape market share?

Market dynamics are determined by the pace of competitor launches and the intensity of generic competition. For a branded oncology drug, the competitive threat stack usually includes:

• Next-generation targeted inhibitors or chemo-immunotherapy switches
• Off-label substitution where evidence is accepted by payors
• Generic entrants after patent cliffs

What competitor classes pressure Caprelsa first?

• Same-target TKIs with better resistance profiles
• Broader-spectrum agents with easier sequencing
• Agents with improved CNS activity where relevant

What is the FDA regulatory status of Caprelsa and how does it impact future revenue?

FDA status influences market life-cycle through:

• Label breadth and indication durability
• Postmarketing requirements that can change clinical use
• Safety updates that alter prescribing behaviors

Does Caprelsa have exclusivity via New Chemical Entity, orphan, or pediatric grants?

Exclusivity type determines whether generic entry is blocked even after some patent expirations. Timing of exclusivity end points can:

• Extend brand revenue beyond patent expiration in some cases
• Create an additional litigation settlement lever for generics

What is the Orange Book status of Caprelsa?

Orange Book status determines:

• Whether ANDAs can be approved immediately on patent expiry or if exclusivity blocks approvals
• Whether the patent portfolio includes multiple listed patents that require each to be addressed

How do manufacturing and IP barriers affect generic or biosimilar-like entry for Caprelsa?

Even if an ANDA is eligible, substitution adoption can be delayed by:

• Formulation complexity or bioavailability requirements
• Supply readiness (ability to meet demand quickly)
• Patent design-around that narrows generic equivalence

For small-molecule TKIs, the key barrier is typically formulation and method-of-use claim scope, not biologic manufacturing complexity.

How does Caprelsa market performance compare with other oncology targeted therapies?

Cross-drug comparisons usually track:

• Rate of share loss after competitor launches
• Time from first generic risk event to sustained price compression
• Net-to-gross margin changes tied to rebate schedules

A standardized way to benchmark is to compare:

• Peak annual sales and post-peak slope
• Patent cliff proximity at time of peak sales
• Competitive entry timeline (new-generation branded TKIs before genericization)

Caprelsa revenue exposure map: what drives the P&L sensitivity profile?

Caprelsa revenue exposure is most sensitive to:

1. Line-of-therapy positioning shifts caused by new evidence or label updates.
2. Net pricing compression driven by formulary tier moves.
3. Generic entry timing under Paragraph IV pathways.

Financial drivers and typical lag effects

• Trial readouts and guideline shifts influence adoption within quarters
• Payor contracting can lag evidence by 6 to 18 months
• Patent-cliff events typically affect net revenue sharply in the approval quarter and following quarters as substitution scales

Caprelsa patent litigation and settlement dynamics: what should be monitored?

Patent litigation affects timing and certainty of generic launch. For business planning, the key inputs are:

• Which patents are asserted
• Whether the court schedules accelerated or delayed trial dates
• Whether settlement agreements impose launch design constraints or pay-for-delay terms (where permitted)

What settlement terms most often matter for brand revenues?

• Launch date caps or “at-risk” launch carve-outs
• Patent list carve-outs that preserve brand exclusivity for certain indications
• Agreement constraints on labeling and marketing claims

Key Takeaways

• Caprelsa’s market dynamics are driven by biomarker-defined demand and competitive pressure from newer targeted agents and sequencing shifts.
• The financial trajectory is highly sensitive to Orange Book-listed patents and regulatory exclusivity expirations, which govern the timing and magnitude of generic erosion.
• Paragraph IV litigation and settlement terms are the principal near-term uncertainties for launch timing and revenue ramp-down.
• Payor coverage and formulary placement are the dominant quarterly levers behind net price declines, often preceding or outpacing competitor impact.

FAQs

1. How do Paragraph IV filings typically affect Caprelsa revenue before patent expiry?
2. What label-specific exclusions can delay generic substitution for Caprelsa?
3. How does formulary tier placement influence persistence rates for Caprelsa patients?
4. What competitive events usually cause step-function changes in branded TKI net sales?
5. How do patent portfolio breadth (composition, formulation, method-of-use) change Caprelsa generic risk?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. U.S. Food and Drug Administration. Drugs@FDA. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
3. U.S. Food and Drug Administration. Drug Trial Snapshots. FDA. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshots

DrugChatter Q&A for CAPRELSA

How does caprelsa treat medullary thyroid cancer?