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. Thirteen 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	240
Clinical Trials:	428
Patent Applications:	19
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

Pharmacology for TARCEVA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

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	021743-003	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-001	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004

International Patents for TARCEVA

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

Country	Patent Number	Title	Estimated Expiration
Hungary	0302665
China	1066142
Norway	20021910
China	100351241
African Intellectual Property Organization (OAPI)	10277	Quinazoline derivatives

Supplementary Protection Certificates for TARCEVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817775	06C0010	France		PRODUCT NAME: ERLOTINIB HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 20050919; FIRST REGISTRATION: LI - 57266 20050321
0817775	CA 2006 00006	Denmark
0817775	300214	Netherlands		300214, 20150606, EXPIRES: 20200320
0817775	SPC001/2006	Ireland		SPC001/2006: 20070817, EXPIRES: 20200320
0817775	C300214	Netherlands		PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321

TARCEVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tarceva

Introduction

Tarceva, also known as erlotinib, is a crucial drug in the treatment of non-small cell lung cancer (NSCLC) and other cancers, particularly those with epidermal growth factor receptor (EGFR) mutations. Here, we delve into the market dynamics and financial trajectory of Tarceva, highlighting its past performance, current status, and future projections.

Historical Performance

Tarceva was first approved by the FDA in 2004 for the treatment of NSCLC and has since been a significant player in the oncology market. In its early years, Tarceva showed promising growth, with U.S. gross sales increasing by 12% in the third quarter of 2007 compared to the same quarter in 2006, primarily due to price increases[4].

Global Sales and Revenue

At its peak, Tarceva achieved substantial global sales. For instance, in 2007, worldwide net sales for Tarceva were guided to be between $855 million and $860 million[4]. However, these figures have declined significantly over the years due to several factors.

Patent Expiration and Generic Competition

One of the major factors impacting Tarceva's sales is the expiration of its patent. Starting in 2016, Tarceva faced patent expiry, leading to a significant decline in its sales. By 2025, the sales of the patented drug in the 8MM (eight major markets) are expected to decrease from $783 million in 2015 to just $18 million. This decline is largely due to the uptake of generic erlotinib, which is expected to reach $77 million in sales by 2025[1].

Market Impact of Generics

The introduction of generic erlotinib has drastically reduced the market share and revenue of branded Tarceva. Generic competition not only reduces the price but also increases the availability of the drug, further eroding the market share of the branded version. This trend is consistent with other blockbuster drugs facing patent expiry, such as Alimta, which also saw a significant decline in sales due to generic competition[1].

Regional Sales Trends

The sales of Tarceva have varied across different regions. While the drug saw initial growth in the U.S. market, its sales have been declining globally. In contrast, other regions like China have seen an increase in the overall NSCLC market, but this growth is driven more by newer targeted therapies rather than older drugs like Tarceva[1].

Competitive Landscape

Tarceva operates in a highly competitive market dominated by newer targeted therapies and immunotherapies. Drugs like AstraZeneca’s Tagrisso (osimertinib) and Roche’s Avastin (bevacizumab) have become more prominent, with Tagrisso projected to achieve blockbuster status by 2025. This shift towards newer, more effective treatments has further marginalized Tarceva’s market position[1].

Financial Projections

The financial trajectory for Tarceva is bleak due to the factors mentioned above. The drug’s sales are expected to continue their downward trend, with minimal revenue anticipated by the end of the forecast period in 2025. This decline is a result of the combined effects of patent expiration, generic competition, and the rise of more effective and targeted therapies[1].

Industry Expert Insights

Industry analysts have long predicted the decline of drugs like Tarceva due to the advent of newer technologies and treatments. For example, analysts at Merrill Lynch & Co. forecasted that products in the same class as Tarceva could reach combined worldwide sales of $6 billion to $10 billion annually, but this was before the impact of generics and newer therapies was fully understood[5].

Conclusion

Tarceva, once a leading drug in the NSCLC market, has seen its sales and market share significantly eroded due to patent expiration, generic competition, and the emergence of more effective targeted therapies. As the oncology market continues to evolve with innovative treatments, the financial trajectory for Tarceva remains challenging.

Key Takeaways

• Patent Expiration: Tarceva’s patent expiry has led to a significant decline in sales.
• Generic Competition: Generic erlotinib has further reduced Tarceva’s market share.
• Competitive Landscape: Newer targeted therapies have become more prominent, marginalizing Tarceva.
• Financial Projections: Minimal revenue is anticipated for Tarceva by 2025.
• Industry Trends: The oncology market is shifting towards more innovative and effective treatments.

FAQs

Q: What is the primary reason for the decline in Tarceva's sales? A: The primary reason is the expiration of its patent, leading to generic competition.

Q: How has the introduction of generic erlotinib affected Tarceva's sales? A: The introduction of generic erlotinib has significantly reduced the sales of branded Tarceva, with generic sales expected to reach $77 million by 2025.

Q: What are some of the newer therapies that have impacted Tarceva's market position? A: Newer targeted therapies such as AstraZeneca’s Tagrisso and Roche’s Avastin have become more prominent and effective, further marginalizing Tarceva.

Q: What is the projected sales figure for Tarceva by 2025? A: By 2025, the sales of the patented drug in the 8MM are expected to decrease to just $18 million.

Q: How does the competitive landscape affect Tarceva's financial trajectory? A: The competitive landscape, dominated by newer and more effective treatments, has significantly impacted Tarceva’s financial trajectory, leading to a decline in its market share and revenue.

Sources

1. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
2. Financial Results of Astellas for Fiscal Year 2019
3. Oncology Drugs Market to Reach USD 532.91 Billion by 2031
4. News Room - News Releases - Astellas Pharma US, Inc.
5. Erlotinib: CP 358774, NSC 718781, OSI 774, R 1415 - PubMed