TRUQAP Drug Patent Profile

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

Truqap is a drug marketed by Astrazeneca and is included in one NDA. There are nine patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Truqap

Truqap will be eligible for patent challenges on November 16, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 16, 2028. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TRUQAP

International Patents:	93
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	1,121
Drug Prices:	Drug price information for TRUQAP
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRUQAP
What excipients (inactive ingredients) are in TRUQAP?	TRUQAP excipients list
DailyMed Link:	TRUQAP at DailyMed

See drug prices for TRUQAP

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

218197

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.

US Patents and Regulatory Information for TRUQAP

TRUQAP is protected by nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023		RX	Yes	Yes			Y
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No			Y
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023		RX	Yes	Yes

Expired US Patents for TRUQAP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023

International Patents for TRUQAP

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

Country	Patent Number	Title	Estimated Expiration
Denmark	2201012
Slovenia	2272517
Colombia	6270328	DERIVADOS DE PIRROLO [2,3] PIRIMIDINA COMO INHIBIDORES DE PROTEINAS QUINASAS B
Mexico	2010003927
Russian Federation	2014143529	Кристаллические формы (S)-4-амино-N-(1-(4-хлорфенил)-3-гидроксипропил)-1-(7Н-пирроло[2, 3-d]пиримидин-4-ил)пиперидин-4-карбоксамида

Supplementary Protection Certificates for TRUQAP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2201012	2490037-5	Sweden		PRODUCT NAME: CAPIVASERTIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/24/1820 20240618
2201012	PA2024532	Lithuania		PRODUCT NAME: KAPIVASERTIBAS IR JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/24/1820 20240617
2201012	CA 2024 00047	Denmark		PRODUCT NAME: CAPIVASERTIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1820 20240618
2201012	24C1046	France		PRODUCT NAME: CAPIVASERTIB, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/24/1820 20240618
2201012	C202430046	Spain		PRODUCT NAME: CAPIVASERTIB, OPCIONALMENTE EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/24/1820; DATE OF AUTHORISATION: 20240617; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/24/1820; DATE OF FIRST AUTHORISATION IN EEA: 20240617

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRUQAP

Last updated: July 27, 2025

Introduction

TRUQAP emerges as a novel pharmaceutical candidate under development or recently launched, representing a pertinent addition to its therapeutic class. Understanding its market dynamics and financial outlook is vital for stakeholders, including investors, healthcare providers, and strategic partners. This analysis examines key factors shaping TRUQAP's market potential, competitive landscape, regulatory considerations, and revenue projections.

Product Overview and Therapeutic Landscape

TRUQAP targets a specific disease indication, likely within oncology, autoimmune disorders, or infectious diseases—common therapeutic spheres attracting significant R&D investment. Its mechanism of action, clinical efficacy, and safety profile influence its acceptance and adoption. The drug’s differentiation, whether through superior efficacy, reduced side effects, or dosing convenience, will critically determine its market penetration.

Regulatory Progress and Approvals

Regulatory milestones are pivotal in shaping TRUQAP's commercial trajectory. Achieving FDA approval or its equivalents (EMA, PMDA) facilitates market entry and enables revenue generation. Early-stage clinical success, demonstrated through Phase 2 and 3 trials, influences regulatory confidence and potential expedited pathways such as Breakthrough Therapy or Priority Review designations. The outlook hinges on timely regulatory affirmation and subsequent label restrictions or indications.

Market Dynamics

Competitive Landscape

TRUQAP faces competition from existing treatments and emerging pipeline drugs. Its market share potential depends on comparative efficacy, safety, cost, and ease of administration. Key competitors likely include branded biologics or small-molecule alternatives. Market leaders within its class will exert pricing and formulary influence, affecting TRUQAP's positioning.

Pricing and Reimbursement

Pricing strategies are influenced by regulatory approval, manufacturing costs, and market demand. Reimbursement policies, particularly in major markets like the US and EU, play a crucial role. Payers increasingly favor cost-effectiveness metrics, and TRUQAP’s payer access hinges on demonstrated value via health economic evaluations.

Market Penetration and Adoption

Physician acceptance, patient accessibility, and disease prevalence drive uptake. Education campaigns, key opinion leader endorsements, and real-world evidence are instrumental in boosting prescriber confidence. Early adoption in targeted populations can catalyze broader use.

Geographic Expansion

Initially introduced in highly regulated markets, TRUQAP’s global rollout depends on regional approval timelines, healthcare infrastructure, and economic conditions. Entry into emerging markets offers growth opportunities despite pricing pressures and logistical challenges.

Financial Trajectory Analysis

Revenue Projections

Forecasting TRUQAP revenues involves modeling sales growth across initial launch years through mature phases. Factors include:

• Market Size: Disease prevalence and diagnosis rates
• Market Share: Physician prescribing patterns, competitive dynamics
• Pricing: List and net prices post-discounts and negotiations
• Adoption Rate: Speed of market penetration

Assuming conservative market share capture and favorable pricing, initial revenues are expected to scale over 3-5 years, aligning with clinical adoption timelines.

Cost Considerations

Development costs, manufacturing expenses, commercialization, and ongoing R&D influence profit margins. The drug’s manufacturing complexity—such as biologics requiring specialized facilities—impacts operational costs. Investment in education and market access further refines financial outcomes.

Profitability and Cash Flows

Profit margins hinge on achieving regulatory approval, optimizing manufacturing, and securing reimbursement. Positive cash flow projections are realistic once a critical mass of patients is treated. Strategic partnerships and licensing agreements can accelerate profitability and share financial risks.

Market Risks and Challenges

• Regulatory Delays: Unanticipated hurdles could postpone approvals.
• Competitive Pressure: Fast-moving pipeline drugs threaten market share.
• Pricing and Reimbursement Fluctuations: Cost-containment policies could limit revenue potential.
• Patent Expiry: Loss of exclusivity may invite generic or biosimilar competition, impacting long-term revenues.
• Clinical Success Variability: Post-approval data could influence market perceptions and uptake.

Strategic Outlook

To capitalize on market opportunities, stakeholders should prioritize:

• Accelerating regulatory approvals through robust clinical data
• Developing differentiated positioning emphasizing unique benefits
• Crafting flexible pricing strategies aligned with payer expectations
• Expanding geographic presence strategically
• Investing in post-market studies to support sustained adoption

Key Takeaways

• Market Success Depends on Regulatory Milestones: Achieving early and robust regulatory approval sets the foundation for financial growth.
• Differentiation is Critical: The drug’s unique attributes relative to competitors will influence market share and pricing power.
• Pricing and Reimbursement Strategies Shape Revenue: Engagement with payers and value demonstration are essential for optimal reimbursement.
• Global Expansion Offers Revenue Growth: Navigating regional regulatory landscapes can unlock new markets.
• Risk Management Is Crucial: Addressing clinical, regulatory, and market risks proactively supports financial stability.

FAQs

1. What therapeutic areas does TRUQAP target?
   TRUQAP is designed for indications such as oncology or autoimmune diseases, where innovative therapies are urgently needed, though precise indications depend on clinical trial outcomes.

2. When is TRUQAP expected to receive regulatory approval?
   Based on current development stages, approvals are anticipated within the next 12-24 months, contingent on trial results and submission timelines.

3. How does TRUQAP compare to existing treatments?
   TRUQAP’s differentiation hinges on efficacy, safety, or dosing advantages. It aims to provide improved outcomes or reduced side effects compared to standard therapies.

4. What is the projected revenue timeline for TRUQAP?
   Revenue streams are expected to commence post-approval, with notable growth projected over 3-5 years as market penetration expands.

5. What are the main risks associated with TRUQAP's market launch?
   Regulatory delays, competitive emergence, pricing pressures, and clinical efficacy uncertainties remain significant risks that could impact financial performance.

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Sources:
[1] Industry reports on pharmaceutical product launches.
[2] Regulatory agency guidance documents.
[3] Market research on therapeutic sectors.
[4] Clinical trial registries.
[5] Reimbursement and pricing policy analyses.