INCIVEK Drug Patent Profile

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

Incivek is a drug marketed by Vertex Pharms and is included in one NDA. There are two patents protecting this drug.

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

The generic ingredient in INCIVEK is telaprevir. There are three drug master file entries for this compound. Additional details are available on the telaprevir profile page.

DrugPatentWatch^® Generic Entry Outlook for Incivek

Incivek was eligible for patent challenges on May 23, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INCIVEK

International Patents:	124
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	12
Patent Applications:	1,782
DailyMed Link:	INCIVEK at DailyMed

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

NDA:

201917

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 INCIVEK

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

Sponsor	Phase
Vertex Pharmaceuticals Incorporated	Phase 2/Phase 3
Timothy Morgan, MD	Phase 2/Phase 3
Santaris Pharma A/S	Phase 2

See all INCIVEK clinical trials

US Patents and Regulatory Information for INCIVEK

INCIVEK is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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 INCIVEK

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

Premature patent expiration for: INCIVEK

Expiration due to failure to pay maintenance fee

Patent Number	Tradename	Expiration Date
	INCIVEK

EU/EMA Drug Approvals for INCIVEK

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 INCIVEK

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

Country	Patent Number	Title	Estimated Expiration
Japan	5269035
Taiwan	200630093	Dose forms
Taiwan	201022242
Canada	2697205	INHIBITEURS PEPTIDOMIMETIQUES DE PROTEASE (PEPTIDOMIMETIC PROTEASE INHIBITORS)
Japan	2004517047
Norway	330807
Canada	2585647	FORMES PHARMACEUTIQUES (DOSE FORMS COMPRISING VX-950 AND THEIR DOSAGE REGIMEN)

Supplementary Protection Certificates for INCIVEK

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
1320540	SPC/GB12/010	United Kingdom		PRODUCT NAME: TELAPREVIR OR PHARMACEUTICALLY ACCEPTABLE SALTS AND/OR SOLVATES OF TELAPREVIR OR SOLVATES OF SUCH SALTS.; REGISTERED: UK EU/1/11/720/001 20110919
1320540	9/2012	Austria		PRODUCT NAME: TELAPREVIR UND JEDE THERAPEUTISCH AEQUIVALENTE FORM DAVON, WELCHE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE PHARMAZEUTISCH VERTRAEGLICHE SALZE UND/ODER SOLVATE VON TELAPREVIR ODER SOLVATE SOLCHER SALZE; REGISTRATION NO/DATE: EU/1/11/720/001 20110919
1320540	C300518	Netherlands		PRODUCT NAME: TELAPREVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF SOLVAAT DAARVAN, OF SOLVATEN VAN DERGELIJKE ZOUTEN; REGISTRATION NO/DATE: EU/1/11/720/001 2011190919
1320540	C01320540/01	Switzerland		FORMER OWNER: VERTEX PHARMACEUTICALS INCORPORATED, US

INCIVEK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of INCIVEK (Telaprevir)

Introduction

INCIVEK, also known as telaprevir, was a groundbreaking hepatitis C treatment developed by Vertex Pharmaceuticals. Launched in May 2011, it quickly made a significant impact on the pharmaceutical market. Here, we delve into the market dynamics and financial trajectory of INCIVEK, highlighting its rapid rise and subsequent challenges.

Rapid Launch and Initial Success

INCIVEK was approved by the FDA on May 23, 2011, and it swiftly became the fastest drug launch in history, surpassing Pfizer's Celebrex. In its first four quarters on the market, INCIVEK generated $1.56 billion in sales, outpacing Celebrex's $1.55 billion[1].

Financial Performance in Early Quarters

The third quarter of 2011 saw INCIVEK contributing significantly to Vertex's financials. The company reported $659 million in total revenues, with $420 million attributed to INCIVEK sales. This performance made Vertex profitable and cash-flow positive in the first full quarter after INCIVEK's launch[2].

Market Impact and Competition

INCIVEK's success was largely due to its efficacy in treating genotype 1 chronic hepatitis C, particularly when combined with pegylated-interferon and ribavirin. It was the most prescribed direct-acting antiviral for this condition and had been used to treat over 17,000 patients[4].

Competitive Landscape

However, the hepatitis C treatment landscape was highly dynamic. The emergence of new oral treatments that did not require interferon therapy significantly impacted INCIVEK's sales. Drugs like sofosbuvir from Gilead Sciences undermined INCIVEK's market position, leading to a sharp decline in sales. By the third quarter of 2012, INCIVEK's sales had dropped to $85.6 million, down from $254.3 million in the same period the previous year[1].

Clinical Trials and Development

INCIVEK's development involved extensive clinical trials. The drug showed promising results, especially in patients co-infected with HIV and hepatitis C. Interim data from a Phase 2 study indicated that 74% of patients had undetectable hepatitis C virus 24 weeks after starting INCIVEK combination treatment[4].

Ongoing and Planned Studies

Vertex planned to initiate a Phase 3 study to evaluate 24- and 48-week treatment durations for patients co-infected with hepatitis C and HIV. This study aimed to further establish INCIVEK's efficacy in challenging patient populations[4].

Financial Trajectory

Initial Revenue Surge

The launch of INCIVEK transformed Vertex's financial profile. In the third quarter of 2011, the company reported net income of $221 million, or $1.02 per diluted share, on a GAAP basis. This was a significant turnaround from the net loss of $209 million in the same quarter the previous year[2].

Decline in Sales

However, as new treatments emerged, INCIVEK's sales plummeted. The decline was so steep that it raised concerns about the drug's long-term viability. By 2012, INCIVEK's sales had been "gutted" as patients and doctors awaited newer, more convenient treatments[1].

Impact on Vertex's Financials

The decline in INCIVEK sales affected Vertex's overall financial performance. Despite the company's efforts to diversify its pipeline with other potential medicines, the drop in INCIVEK revenues was a significant setback. Vertex had to adjust its financial projections and focus on other promising drugs in its pipeline[2].

Side Effects and Safety Profile

INCIVEK, while effective, came with notable side effects. The most serious side effects included rash and anemia, which led to treatment discontinuation in about 1% of patients. Common side effects included fatigue, itching, nausea, and diarrhea[4].

Regulatory and Market Challenges

Regulatory Environment

The regulatory environment played a crucial role in INCIVEK's market trajectory. The FDA approval was a significant milestone, but the emergence of new treatments with better safety profiles and convenience led to a shift in regulatory and market preferences[1].

Market Shifts

The market for hepatitis C treatments underwent a significant transformation during INCIVEK's lifecycle. The introduction of interferon-free regimens changed patient and physician preferences, making INCIVEK less competitive. This shift was exemplified by the success of drugs like sofosbuvir, which offered a more patient-friendly treatment option[1].

Key Takeaways

• Rapid Launch Success: INCIVEK was the fastest drug launch in history, generating $1.56 billion in its first four quarters.
• Market Impact: It significantly impacted the hepatitis C treatment landscape but faced intense competition from newer treatments.
• Financial Performance: INCIVEK's sales drove Vertex's profitability in early quarters but declined sharply as new treatments emerged.
• Clinical Trials: The drug showed promising results in clinical trials, especially in co-infected patients.
• Side Effects: INCIVEK had notable side effects, including rash and anemia.
• Regulatory and Market Challenges: The drug faced challenges from regulatory and market shifts favoring newer, interferon-free treatments.

FAQs

What was the significance of INCIVEK's launch in the pharmaceutical market?

INCIVEK was the fastest drug launch in history, surpassing Celebrex's record by generating $1.56 billion in its first four quarters on the market.

How did INCIVEK's sales impact Vertex Pharmaceuticals' financials?

INCIVEK's sales drove Vertex to profitability and cash-flow positivity in the first full quarter after its launch, but subsequent declines in sales affected the company's financial performance.

What were the main side effects associated with INCIVEK?

The most serious side effects included rash and anemia, while common side effects included fatigue, itching, nausea, and diarrhea.

Why did INCIVEK's sales decline so sharply?

The emergence of new oral hepatitis C treatments that did not require interferon therapy significantly undermined INCIVEK's market position, leading to a sharp decline in sales.

What other treatments did INCIVEK face competition from?

INCIVEK faced competition from drugs like sofosbuvir from Gilead Sciences, which offered interferon-free regimens and better patient outcomes.

Sources

1. FiercePharma: "Vertex's Incivek unseats Celebrex as fastest drug launch ever"
2. Vertex Pharmaceuticals: "Vertex Reports Profitable Third Quarter and Provides Updates on INCIVEKTM (telaprevir) Launch and Medicines in Development"
3. Vertex Pharmaceuticals: "Vertex Pharmaceuticals Reviews 2008 Business Priorities and Reports 2007 Financial Results"
4. Vertex Pharmaceuticals: "Positive Interim Data From a Phase 2 Study of INCIVEK™ (telaprevir) Combination Therapy in People Co-Infected with Hepatitis C and HIV Presented at The Liver Meeting®"