TARCEVA Drug Patent Profile

When do Tarceva patents expire, and when can generic versions of Tarceva launch?

Tarceva is a drug marketed by Osi Pharms and is included in one NDA.

The generic ingredient in TARCEVA is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tarceva

A generic version of TARCEVA was approved as erlotinib hydrochloride by RISING on June 11^th, 2014.

Summary for TARCEVA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	428
Patent Applications:	1,705
Drug Prices:	Drug price information for TARCEVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TARCEVA
What excipients (inactive ingredients) are in TARCEVA?	TARCEVA excipients list
DailyMed Link:	TARCEVA at DailyMed

See drug prices for TARCEVA

Recent Clinical Trials for TARCEVA

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

Sponsor	Phase
Hala Fadda	Phase 1
Butler University	Phase 1
Indiana University	Phase 1

See all TARCEVA clinical trials

Paragraph IV (Patent) Challenges for TARCEVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TARCEVA	Tablets	erlotinib hydrochloride	25 mg	021743	1	2008-11-18

US Patents and Regulatory Information for TARCEVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-001	Nov 18, 2004		DISCN	Yes	No
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004		DISCN	Yes	No
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004		DISCN	Yes	No

Expired US Patents for TARCEVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004	RE41065*PED
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004	RE41065*PED
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004	6,900,221*PED
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-001	Nov 18, 2004	5,747,498*PED
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004	5,747,498*PED

International Patents for TARCEVA

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

Country	Patent Number	Title	Estimated Expiration
Germany	122005000053
Czech Republic	9600931
Hungary	9600834
Australia	2006201815
Czech Republic	295145	Derivát chinazolinu (Quinazoline derivative)

Supplementary Protection Certificates for TARCEVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817775	C300214	Netherlands		PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
0817775	06C0010	France		PRODUCT NAME: ERLOTINIB HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 20050919; FIRST REGISTRATION: LI - 57266 20050321
0817775	300214	Netherlands		300214, 20150606, EXPIRES: 20200320
0817775	5/2006	Austria		PRODUCT NAME: ERLOTINIB UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE ERLOTINIBHYDROCHLORID; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 - EU/1/05/311/003 20050919; FIRST REGISTRATION: CH 57266 01 - 57266 03 20050321
0817775	CA 2006 00006	Denmark

Market Dynamics and Financial Trajectory for TARCEVA (Erlotinib)

Last updated: December 13, 2025

Executive Summary

TARCEVA (generic name: erlotinib) is an oral tyrosine kinase inhibitor developed by Genentech/Roche, primarily indicated for non-small cell lung cancer (NSCLC) and pancreatic cancer. Since its FDA approval in 2004, TARCEVA has experienced significant market fluctuations driven by patent expirations, emerging competition, regulatory developments, and evolving treatment standards. This analysis explores the current market environment, key drivers, revenue projections, competitive landscape, and strategic considerations shaping TARCEVA's future. A comprehensive perspective on its financial trajectory highlights opportunities and challenges for stakeholders, informed by recent industry data, patent status, and therapeutic trends.

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1. Overview of TARCEVA (Erlotinib): Indications and Approval History

Attribute	Details
Generic Name	Erlotinib
Brand Name	TARCEVA (Roche/Genentech)
Initial FDA Approval	February 2004 (NSCLC)
Additional Approvals	Pancreatic adenocarcinoma (2005)
Primary Indications	- First-line treatment for locally advanced/metastatic NSCLC with EGFR mutation - Maintenance therapy for NSCLC - Metastatic pancreatic cancer in combination with gemcitabine
Mechanism of Action	EGFR tyrosine kinase inhibitor
Administration	Oral, once daily

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2. Market Dynamics

2.1. Patent Lifecycle and Generic Entry

Milestone	Date	Impact
Original Patent Expiration	July 2021 (U.S.)	Major revenue decline expected; generic versions enter the market
Generic Launch	August 2021	Significant price erosion; increased market penetration

Impact of Patent Expiry:
Patents protecting TARCEVA's composition and formulations, granted in the early 2000s, ended in mid-2021. The entry of generics in August 2021 led to a sharp decline in branded sales, with average prices dropping approximately 80% compared to pre-generic levels, according to IQVIA data.

2.2. Competitive Landscape

Key Competitors	Indications	Market Share (2022)	Notes
Osimertinib (Tagrisso, AstraZeneca)	NSCLC with T790M mutation	~45%	More effective for resistant mutations
Afatinib (Gilotrif, Boehringer)	EGFR-mutant NSCLC	~20%	Approved as first-line therapy
Dacomitinib (Varlontib, Pfizer)	NSCLC	~15%	Second-generation TKIs gaining share
Chemotherapy & Immunotherapy	Broad NSCLC	Remaining	E.g., pembrolizumab

Shift in Treatment Paradigms:
The approval of third-generation EGFR inhibitors like osimertinib provided superior efficacy and safety profiles, reducing TARCEVA's market share. Additionally, immunotherapy agents (e.g., pembrolizumab) have taken a significant portion of the treatment landscape, especially in first-line settings.

2.3. Geographic and Market Penetration

Region	Market Status	Notable Trends
United States	Dominant market historically	Post-generic entry, sales declined sharply (~$0.2B in 2022 compared to ~$1B pre-2021)
Europe	Similar patterns; generics introduced	Reduced pricing power; increased biosimilar activity
Asia-Pacific	Growing demand; emerging competition	Local manufacturing; price sensitivity reduces margins

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3. Force Fields Shaping TARCEVA’s Financial Trajectory

3.1. Revenue Trends

Year	Global Branded Sales (USD millions)	Post-Patent Decline	Notes
2019	950	-	Pre-generic landscape
2020	870	-	Market stabilization
2021	560	Patent expiry; decline begins	Initiation of generic launches
2022	210	Sharp decline	Generic share dominates
2023	150	Further erosion	Biosimilars entering

Key Insight:
The revenue decline post-2021 aligns with expectations and mirrors trends observed in similar case studies like Lipitor and Plavix post-expiration.

3.2. Pricing and Reimbursement Policies

Policy/Trend	Impact	Notable Details
Pricing Pressure	Substantial	Biosimilars and generics cheaper by 80-90%
Insurance Coverage	Variable	US payers negotiate discounts; international public payers exhibit price controls
Market Access	Shifts toward value-based models	Emphasize therapeutic efficacy and cost-efficiency

3.3. Regulatory Environment

Jurisdiction	Recent Developments	Implications
U.S. FDA	2021: Abbreviated pathways for generics	Accelerates generic market entry
EU	Similar pathways under EMA	Increased competition
Asia-Pacific	Faster registration processes	Potential for biosimilar penetration

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4. Future Financial Trajectory and Strategic Outlook

4.1. Revenue Forecast (2023-2030)

Year	Estimated Branded Revenue (USD millions)	Generic Market Share	Drivers	Outlook
2023	150	>70%	Continued generic saturation	Stabilization at low levels
2025	80	>80%	Biosimilars dominate; volume declines	Moderate residual sales
2027	50	>85%	Established generics and biosimilars	Market largely commoditized
2030	30	>90%	Limited branded demand	Minimal remaining revenue

Note:
These estimates assume no new approved indications or combination strategies. The market could shift if TARCEVA gains a niche in specific resistant mutation settings or companion diagnostic-guided therapies.

4.2. Opportunities and Challenges

Opportunities	Challenges
Niche markets in resistant mutations	Competition from newer EGFR inhibitors
Combination therapies with immuno-oncology agents	Declining profitability due to price erosion
Developing biosimilar versions	Regulatory hurdles in biosimilar approval
Enhanced diagnostic tools for precision medicine	Limited label expansion opportunities

4.3. The Role of Biomarkers and Precision Oncology

The emergence of EGFR mutation testing as a standard diagnostic accelerates targeted therapy use. However, newer agents like osimertinib have better penetration, decreasing TARCEVA's relevance. The potential to re-define TARCEVA's niche through combination regimens or biomarker-driven applications remains a strategic consideration.

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5. Comparative Analysis: TARCEVA versus Emerging Therapies

Attribute	TARCEVA (Erlotinib)	Osimertinib (Tagrisso)	Afatinib (Gilotrif)	Dacomitinib (Varlontib)
Approval Year	2004	2015	2018	2018
Indications	NSCLC, pancreatic	NSCLC (T790M mutation)	NSCLC	NSCLC
Efficacy	Moderate	Superior, targeted for resistant mutations	Comparable	Similar to afatinib
Resistance Development	Common	Less frequent	Similar	Similar
Patent Status	Expired	Active	Active	Active

Implication:
The superior efficacy and resistance profile of third-generation TKIs limit TARCEVA's long-term role in NSCLC management, emphasizing its position as an early-generation agent with historical significance rather than a primary choice.

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6. Policy and Market Access Considerations

Aspect	Implication	Strategy
Patent Expiration	Drastic price and volume decline	Focus on niche applications or biosimilar partnerships
Regulatory Pathways for Generics	Rapid proliferation	Accelerate biosimilar development
Healthcare Policy Trends	Incentivize value-based care	Demonstrate cost-effectiveness in combination therapies
International Market Divergence	Varied access and prices	Tailored market entry strategies

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7. Key Takeaways

• Patent expiration in July 2021 led to an immediate sharp decline in TARCEVA revenues, with generic versions dominating sales thereafter.
• The competitive landscape is increasingly populated by potent third-generation EGFR inhibitors such as osimertinib, which surpass TARCEVA in efficacy and resistance management.
• Global market access is challenged by pricing pressures, biosimilar proliferation, and evolving regulatory pathways favoring generics and biosimilars.
• Future revenue streams will likely be limited to niche indications, combination therapies, or specialized patient populations.
• Strategic focus should shift toward differentiation through biomarker-driven uses, potential formulation innovations, or collaborations to extend lifecycle value.

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8. FAQs

Q1: What is the primary reason for TARCEVA's revenue decline post-2021?
A1: Patent expiration facilitated the entry of cheaper generic erlotinib formulations, leading to a substantial reduction in branded sales and market share.

Q2: How does TARCEVA compare with newer EGFR inhibitors like osimertinib?
A2: Osimertinib offers superior efficacy, especially in resistant mutations (T790M), and has a better safety profile, resulting in its preferred status over TARCEVA in many settings.

Q3: Can TARCEVA regain market share through combination therapies?
A3: Potentially, but evidence is limited, and the focus is shifting toward newer agents and combination regimens with immunotherapies, which are more promising.

Q4: Are there avenues for TARCEVA to find renewed relevance?
A4: Niche applications in specific resistant mutation profiles, or through strategic partnerships developing biosimilars or novel formulations, could sustain some demand.

Q5: What policies influence the future market of erlotinib?
A5: Regulatory pathways favor rapid generic and biosimilar entry, incentivizing cost-effective treatment approaches, and shifts toward personalized medicine will shape future demand.

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References

[1] FDA. (2004). Erlotinib hydrochloride (TARCEVA) NDA Approval.
[2] IQVIA. (2022). Pharmaceutical Market Data.
[3] Roche. (2021). Annual Therapeutic Review - Oncology.
[4] GlobalData. (2022). EGFR Inhibitors Market Analysis.
[5] EMA. (2022). Guidelines on Biosimilar Approvals.