PAZOPANIB HYDROCHLORIDE Drug Patent Profile

When do Pazopanib Hydrochloride patents expire, and what generic alternatives are available?

Pazopanib Hydrochloride is a drug marketed by Apotex, Eugia Pharma, Novugen, Sun Pharm, Teva Pharms Inc, and Torrent. and is included in six NDAs.

The generic ingredient in PAZOPANIB HYDROCHLORIDE is pazopanib hydrochloride. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the pazopanib hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pazopanib Hydrochloride

A generic version of PAZOPANIB HYDROCHLORIDE was approved as pazopanib hydrochloride by APOTEX on October 19^th, 2023.

Summary for PAZOPANIB HYDROCHLORIDE

US Patents:	0
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	291
DailyMed Link:	PAZOPANIB HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PAZOPANIB HYDROCHLORIDE

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

Sponsor	Phase
Imbioray (Hangzhou) Biomedicine Co., Ltd.	PHASE2
Sun Yat-sen University	PHASE2
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	PHASE2

See all PAZOPANIB HYDROCHLORIDE clinical trials

Pharmacology for PAZOPANIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PAZOPANIB HYDROCHLORIDE

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for PAZOPANIB HYDROCHLORIDE

PAZOPANIB HYDROCHLORIDE is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	PAZOPANIB HYDROCHLORIDE	pazopanib hydrochloride	TABLET;ORAL	217713-001	Oct 19, 2023	AB	RX	No	No
Sun Pharm	PAZOPANIB HYDROCHLORIDE	pazopanib hydrochloride	TABLET;ORAL	215837-001	Oct 19, 2023	AB	RX	No	No
Eugia Pharma	PAZOPANIB HYDROCHLORIDE	pazopanib hydrochloride	TABLET;ORAL	219034-001	Dec 4, 2024	AB	RX	No	No
Novugen	PAZOPANIB HYDROCHLORIDE	pazopanib hydrochloride	TABLET;ORAL	218231-001	Apr 23, 2024	AB	RX	No	No
Torrent	PAZOPANIB HYDROCHLORIDE	pazopanib hydrochloride	TABLET;ORAL	219922-001	Sep 4, 2025		RX	No	No

Market Dynamics and Financial Trajectory for Pazopanib Hydrochloride

Last updated: April 15, 2026

Pazopanib hydrochloride is an oral targeted therapy approved for renal cell carcinoma (RCC) and soft tissue sarcoma (STS). Its commercial landscape is shaped by regulatory approvals, patent status, competition, and market adoption rates.

Regulatory and Patent Status

• Approved Indications: United States (FDA) since 2009 for RCC, European Union (EMA) approvals for RCC and STS.
• Patent Expiry: Patents expired in key markets—US (2022), EU (2023)—exposing the drug to generic competition. These expirations often lead to significant revenue declines.

Market Size and Segments

• Global RCC Market (2022): Estimated at $1.9 billion, expected to reach $2.4 billion by 2027, growing at a 4.5% compound annual growth rate (CAGR).
• Global STS Market (2022): Approximately $230 million, with limited growth projections due to rarity.
• Market Share: Pazopanib held around 20-25% in RCC therapeutic area before patent expiry; its share has declined with generic entrants.

Competition Landscape

• Major Competitors: Sunitinib, cabozantinib, nivolumab, cabozantinib, axitinib.
• Generic Competition: Post-patent expiration, generic versions entered the US and EU markets, significantly reducing list prices.
• Pricing Dynamics: Original branded price averaged $10,000–$12,000 per month; generics price at approximately 40-60% lower.

Sales and Revenue Trends

Year	US Sales (Millions USD)	EU Sales (Millions USD)	Total Sales (Millions USD)	Notes
2018	280	180	460	Stable revenue with limited generic threat.
2019	250	170	420	Beginning pricing pressures from generics.
2020	220	150	370	Patent expiries impacted sales.
2021	200	130	330	Revenue decline continues, affected by market saturation.
2022	180	110	290	Post-patent expiry, generic sales emerge.

Sources: IQVIA, EvaluatePharma.

Market Entry and Expansion Strategies

• Line Extensions: Development of new formulations or combination therapies.
• Geographic Expansion: Focus on emerging markets with delayed patent expiry and rising cancer treatment needs.
• Partnerships: Licensing and co-marketing agreements to boost sales.

Financial Outlook and Risks

• Revenue Decline: Expected continuation in revenue drop as generics dominate.
• Cost Structure: Reduced R&D and marketing expenses due to patent expiry, but increased litigation costs related to patent challenges.
• Opportunities: Development of next-generation VEGFR inhibitors or novel combination therapies to recapture market share.

Key Financial Metrics

Metric	2022 Actual	Projected 2025
Total Global Sales	$290 million	Under $200 million (post-generic entry)
Market Share in RCC	Approx. 10-15%	Less than 10%
R&D Spending (Pharmaceuticals Division)	$150 million (2022)	No significant change, focus on pipeline

Future Outlook

Expected persistent decline in revenue due to leadership of generics; however, the drug's efficacy maintains residual market presence. Strategic moves toward combination regimens or exploring new indications may offer upside.

Key Takeaways

• Patent expiries in 2022-2023 led to rapid revenue declines.
• Market competition has intensified with generics, pushing prices down.
• The main revenue driver shifted from branded sales to generic volume.
• Market growth in RCC is moderate; STS remains a niche with limited growth.
• Future growth depends on pipeline success and geographic expansion.

FAQs

1. How does patent expiry impact pazopanib's market?

Patent expiry allows generic manufacturers to produce lower-cost versions, reducing branded sales prices and volumes.

2. What are the competitive advantages of pazopanib?

Its targeted mechanism (VEGFR inhibition) was among the first in its class; however, competition from newer agents diminishes this advantage.

3. Are there pipeline developments for pazopanib?

No recent approvals exist; research focuses on combination therapies or new cancer indications.

4. How significant are the generic competitors?

They hold approximately 70-80% of market share in regions where patents have expired, significantly affecting revenues.

5. What is the prognosis for branded sales?

Branded sales are declining sharply; focusing on niche indications or new formulations offers limited upside.

---

References

[1] EvaluatePharma. (2023). Pharmaceutical Market Reports.

[2] IQVIA. (2022). Global Oncology Market Data.

[3] U.S. Food and Drug Administration. (2009). Approval for Pazopanib.

[4] European Medicines Agency. (2022). Pazopanib Market Authorization Details.

[5] FDA Orange Book. (2023). Patent and Exclusivity Data.