Telaprevir - Generic Drug Details

What are the generic sources for telaprevir and what is the scope of patent protection?

Telaprevir is the generic ingredient in one branded drug marketed by Vertex Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Telaprevir has one hundred and twenty-four patent family members in thirty-eight countries.

There are three drug master file entries for telaprevir.

Summary for telaprevir

International Patents:	124
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	103
Patent Applications:	3,978
DailyMed Link:	telaprevir at DailyMed

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

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 telaprevir

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 4
National Taiwan University Hospital	Phase 4
Dayanand Medical College and Hospital

See all telaprevir clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for telaprevir

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for telaprevir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vertex Pharms	INCIVEK	telaprevir	TABLET;ORAL	201917-001	May 23, 2011		DISCN	No	No
Vertex Pharms	INCIVEK	telaprevir	TABLET;ORAL	201917-001	May 23, 2011		DISCN	No	No			Y	Y

Expired US Patents for telaprevir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vertex Pharms	INCIVEK	telaprevir	TABLET;ORAL	201917-001	May 23, 2011

EU/EMA Drug Approvals for telaprevir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Incivo	telaprevir	EMEA/H/C/002313 Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):who are treatment naïve;who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.	Withdrawn	no	no	no	2011-09-19

International Patents for telaprevir

Country	Patent Number	Title	Estimated Expiration
Japan	5269035
Taiwan	200630093	Dose forms
Taiwan	201022242

Supplementary Protection Certificates for telaprevir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1320540	CR 2012 00007	Denmark		PRODUCT NAME: TELAPREVIR OG FARMACEUTISK ACCEPTABLE SALTE OG/ELLER SOLVATER AF TELAPREVIR ELLER SOLVATER AF SADANNE SALTE; REG. NO/DATE: EU/1/11/720/001 20110919
1320540	CA 2012 00007	Denmark
1320540	2012/009	Ireland		PRODUCT NAME: TELAPREVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT AND/OR SOLVATE THEREOF OR SOLVATES OF SUCH SALTS; REGISTRATION NO/DATE: EU/1/11/720/001 20110919

Telaprevir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Telaprevir

Introduction

Telaprevir, marketed under the brand name Incivek, is a significant advancement in the treatment of chronic Hepatitis C Virus (HCV) infections, particularly for genotype 1. Here, we delve into the market dynamics and financial trajectory of this drug.

Development and Approval

Telaprevir was developed by Vertex Pharmaceuticals and approved by the FDA in May 2011 for the treatment of chronic HCV genotype 1 infection in combination with ribavirin and peginterferon alfa-2a or peginterferon alfa-2b[1].

Clinical Trials and Collaboration

The development of telaprevir involved extensive clinical trials, including the PROVE 1 and PROVE 2 trials, which were part of a global Phase 2b development program. Vertex collaborated with Janssen Pharmaceutica for the development and commercialization of telaprevir in Europe and other territories outside North America. This collaboration included significant financial milestones, with Vertex receiving an upfront payment of $165 million and potential milestone payments of up to $380 million[3].

Financial Transactions and Milestones

Vertex Pharmaceuticals secured substantial funding through various financial transactions related to telaprevir. In 2009, Vertex received approximately $155 million in cash from the issuance of notes and the sale of rights to future milestone payments tied to the launch of telaprevir in Europe. These transactions included $120 million for notes secured by future milestone payments and $35 million for the sale of rights to additional milestone payments[2].

Market Performance and Sales

Upon its launch, telaprevir was a significant player in the HCV treatment market. However, the market dynamics quickly shifted with the introduction of newer, more effective direct-acting antivirals (DAAs). Despite its initial success, the sales of telaprevir declined as these newer treatments gained market share. As a result, Incivek was eventually withdrawn from the market[1].

Global Market Size and Projections

Although telaprevir itself is no longer a dominant force in the HCV treatment market, the global market for HCV treatments continues to grow. The global telaprevir market, though not specifically thriving due to the drug's withdrawal, is part of a broader HCV treatment market that was valued at approximately USD 1.2 billion in 2023 and is anticipated to reach around USD 2.6 billion by 2032[4].

Royalties and Revenue Streams

Vertex retained exclusive commercial rights to telaprevir in North America and benefited from tiered royalties on product sales in Janssen's territories, averaging in the mid-20% range. This royalty structure ensured a continued revenue stream for Vertex even after the drug's market presence diminished[3].

Challenges and Competition

The development and commercialization of telaprevir faced several challenges, including the risk of regulatory delays, unfavorable clinical trial results, and competitive pressures from other HCV treatments. The barrier for developing resistance to NS3/4A inhibitors, such as telaprevir, was lower compared to other DAAs, which further complicated its long-term market viability[1].

Conclusion on Financial Trajectory

The financial trajectory of telaprevir was marked by significant upfront investments, collaborative agreements, and initial market success followed by a decline due to competitive forces. Despite its withdrawal from the market, the financial transactions and royalties associated with telaprevir provided substantial revenue for Vertex Pharmaceuticals.

Key Takeaways

• Approval and Launch: Telaprevir was approved by the FDA in 2011 and launched as Incivek.
• Collaboration: Vertex collaborated with Janssen for development and commercialization outside North America.
• Financial Transactions: Vertex received significant funding through notes and milestone payments.
• Market Decline: The drug's market presence declined due to newer DAAs.
• Royalties: Vertex benefited from royalties on sales in Janssen's territories.
• Global Market: The broader HCV treatment market continues to grow.

FAQs

Q: What is telaprevir used for? A: Telaprevir is used in combination with other antivirals for the treatment of chronic Hepatitis C Virus (HCV) genotype 1 infections.

Q: Who developed telaprevir? A: Telaprevir was developed by Vertex Pharmaceuticals.

Q: What was the outcome of the clinical trials for telaprevir? A: The clinical trials, including PROVE 1 and PROVE 2, showed promising results, leading to FDA approval in 2011.

Q: Why was telaprevir withdrawn from the market? A: Telaprevir was withdrawn due to the introduction of more effective direct-acting antivirals (DAAs) that offered better treatment outcomes.

Q: What financial benefits did Vertex receive from telaprevir? A: Vertex received significant upfront payments, milestone payments, and royalties from the sales of telaprevir in Janssen's territories.

Sources

1. DrugBank Online - Telaprevir: Uses, Interactions, Mechanism of Action
2. Vertex Pharmaceuticals - Vertex to Receive $155 Million in Cash Related to Future Telaprevir Milestone Payments
3. Vertex Pharmaceuticals - PROVE 1 and PROVE 2 Clinical Trials
4. Dataintelo - Global Telaprevir Market Research Report 2032
5. FDA - Clinical Pharmacology Review of Telaprevir (VX-950)