ATRASENTAN HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for atrasentan hydrochloride and what is the scope of patent protection?

Atrasentan hydrochloride is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Atrasentan hydrochloride has fifty-two patent family members in twenty-two countries.

There is one drug master file entry for atrasentan hydrochloride. One supplier is listed for this compound.

Summary for ATRASENTAN HYDROCHLORIDE

International Patents:	52
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	20
Patent Applications:	235
DailyMed Link:	ATRASENTAN HYDROCHLORIDE at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 ATRASENTAN HYDROCHLORIDE

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

Sponsor	Phase
Chinook Therapeutics, Inc.	Phase 2
Chinook Therapeutics U.S., Inc.	Phase 2
Chinook Therapeutics U.S., Inc.	Phase 3

See all ATRASENTAN HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for ATRASENTAN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	VANRAFIA	atrasentan hydrochloride	TABLET;ORAL	219208-001	Apr 2, 2025		RX	Yes	Yes
Novartis	VANRAFIA	atrasentan hydrochloride	TABLET;ORAL	219208-001	Apr 2, 2025		RX	Yes	Yes
Novartis	VANRAFIA	atrasentan hydrochloride	TABLET;ORAL	219208-001	Apr 2, 2025		RX	Yes	Yes
Novartis	VANRAFIA	atrasentan hydrochloride	TABLET;ORAL	219208-001	Apr 2, 2025		RX	Yes	Yes
Novartis	VANRAFIA	atrasentan hydrochloride	TABLET;ORAL	219208-001	Apr 2, 2025		RX	Yes	Yes

International Patents for ATRASENTAN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Singapore	11201600107R	STABILIZED PHARMACEUTICAL DOSAGE FORMS COMPRISING ATRASENTAN
Japan	2016530238	アトラセンタンを含有する安定化医薬剤型
Japan	2017145251	糖尿病の合併症のための療法 (THERAPY FOR COMPLICATIONS OF DIABETES)
Mexico	2016000188	FORMAS DE DOSIFICACION FARMACEUTICA ESTABILIZADAS QUE COMPRENDEN ATRASENTAN. (STABILIZED PHARMACEUTICAL DOSAGE FORMS COMPRISING ATRASENTAN.)
Singapore	10201700596P	STABILIZED PHARMACEUTICAL DOSAGE FORMS COMPRISING ATRASENTAN

Market Dynamics and Financial Trajectory for Atrasentan Hydrochloride

Last updated: February 21, 2026

Atrasentan hydrochloride is an experimental drug primarily developed for the treatment of prostate cancer and conditions related to prostate tumor growth. Its market evolution hinges on clinical trial results, regulatory approvals, and competitive landscape developments. Its financial trajectory reflects ongoing R&D investments, potential commercialization milestones, and strategic partnerships.

Current Clinical Development Status

Atrasentan hydrochloride is developed by AbbVie Inc. as part of its oncology pipeline. The drug has received Orphan Drug Designation from the FDA for prostate cancer indications, which provides certain incentives but does not guarantee approval.

Clinical Trials and Regulatory Pathways

Stage	Details	Expected Timeline
Phase 2 Trials	Completed; showed potential in delaying prostate cancer progression	2018-2020
Phase 3 Trials	Ongoing; assessing efficacy in metastatic castration-resistant prostate cancer (mCRPC)	Expected completion: 2024-2025
Regulatory Submission	Pending; dependent on clinical data outcomes	Estimated: 2026

Key Data Points

• Trials assess atrasentan’s impact on tumor growth delay, safety, and tolerability.
• The primary endpoint in current Phase 3 studies is progression-free survival.
• No approval observed yet; commercial launch hinges on positive trial results and regulatory clearance.

Market Size and Competitive Landscape

The global prostate cancer market was valued at approximately $9 billion in 2021 and is projected to reach $14.8 billion by 2028, growing at a CAGR of 7.5% (Frost & Sullivan, 2022).

Competitive Agents

Drug	Class	Status	Market Share (2022)	Notes
Zytiga (abiraterone)	Androgen biosynthesis inhibitor	Approved	35%	First-line in mCRPC, multiple combination therapies
Xtandi (enzalutamide)	Androgen receptor inhibitor	Approved	30%	Similar indications, potential competition from atrasentan
Chemotherapy (docetaxel)	Microtubule inhibitor	Approved	15%	Used post-androgen therapy failure

Atrasentan’s competitive advantage depends on clinical superiority in delaying disease progression, safety profile, and dosing convenience.

Financial Outlook and Investment Considerations

R&D Investment

• Estimated R&D spending for atrasentan hydrochloride exceeds $200 million across preclinical and clinical phases.
• Continued investments are necessary until regulatory approval; costs escalate at late-stage trials.

Revenue Potential

• If approved, atrasentan could command a premium pricing model due to orphan drug status.
• Estimated annual treatment cost: $50,000–$70,000 (based on comparable targeted therapies).

Market Entry Risks

• Uncertainty regarding trial outcomes.
• Competitive pressure from existing therapies.
• Regulatory delays or rejections.
• Off-label use limitations and reimbursement hurdles.

Strategic Opportunities

• Collaboration with biotech and oncology firms.
• Licensing deals for regional markets.
• Companion diagnostics development.

Financial Impact Summary

Variable	Impact	Notes
Clinical trial results	Critical; positive results accelerate approval
Regulatory approval	Major value inflection point	Approvals could enable commercialization
Market penetration	Depends on efficacy, safety, and pricing	Market share could be limited initially
Competitive responses	Could pressure pricing and uptake	Existing drugs have established presences

Timeline Outlook

• 2024–2025: Completion of Phase 3 trials.
• 2026: Anticipated regulatory submission.
• 2027–2028: Possible commercialization, contingent on approval.

Summary

Atrasentan hydrochloride remains in late-stage clinical development with potential for market entry in prostate cancer. Its financial success depends on positive trial data, regulatory approval, and market acceptance amidst competitors. Investment risks remain high, but the drug's orphan status and targeted profile present opportunities for niche market capture if clinical outcomes are favorable.

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Key Takeaways

• Atrasentan hydrochloride is advancing through Phase 3 trials with regulatory submission projected around 2026.
• The prostate cancer market is mature, with key competitors dominating market share.
• Financial prospects depend on clinical outcomes, regulatory clearances, and strategic commercialization efforts.
• R&D costs are substantial and ongoing until approval, impacting valuation and investment decisions.
• Market entry would provide a niche but potentially lucrative option within oncology therapies.

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FAQs

1. What is the clinical promise of atrasentan hydrochloride?
It aims to delay prostate cancer progression, particularly in metastatic castration-resistant cases, with ongoing trials evaluating its efficacy and safety.

2. How does atrasentan compare to existing prostate cancer treatments?
Pending clinical data, its potential advantage is targeted therapy with possibly fewer side effects, but its efficacy relative to approved drugs remains unconfirmed.

3. When might atrasentan reach the market?
Regulatory submission is expected around 2026, with commercial availability possibly by 2027–2028 if approved.

4. What are the main risks for investing in atrasentan hydrochloride?
Risks include failed clinical trials, regulatory rejection, market competition, and pricing pressures.

5. How significant is orphan drug status for its commercial prospects?
Orphan status provides incentives such as exclusivity and tax benefits, which can enhance profitability margins if the drug gains approval.

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References

[1] Frost & Sullivan. (2022). Global prostate cancer market forecasts. Retrieved from https://www.frost.com.