Top Performing Drug of 2021 – Xarelto (November Edition)

Active Ingredient: rivaroxaban

Strength: 2.5 mg, 10 mg, 15 mg, and 20 mg

Dosage Form: Tablets

Mechanism of Action: Factor Xa inhibitors

First Approval: US (1 Jul 2011), EU (30 Sep 2008)

Revenue Analysis of Xarelto¹

Xarelto has been an important driver of the revenue generated from the cardiovascular portfolio of Janssen. The blood thinner showed an increase of 4% in 2021 revenue vs. 2020. Xarelto is co-developed with Bayer HealthCare AG. PharmaShots has done the revenue analysis of Xarelto sales from the past 5 years.

In 2019, Xarelto's revenue decreased to $2.31Bn, showing a decline of 6.6% vs. 2018. Xarelto’s sales volume growth was offset by higher discounts and rebates and tough competition from other growing blood thinners in the market.
In 2020, the growth of Xarelto was due to demand growth partially offset by higher rebates. Also, due to changes in the 2018 Medicare policy sales revenue decreased.²
In 2021, Janssen got FDA approval for Xarelto in Peripheral Artery Disease (PAD) + Aspirin to include patients after LER which started to contribute to the growth of Xarelto.³

Approved Indications of Xarelto⁴

XARELTO is a factor Xa inhibitor indicated for the: 

 • Reduction in the risk of stroke and systemic embolism in nonvalvular atrial fibrillation 

• Treatment of deep vein thrombosis (DVT) 

• Treatment of pulmonary embolism (PE) 

• Reduction in the risk of recurrence of DVT or PE 

• Prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery 

• Prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients • to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) 

• Reduction in the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD 

• Treatment of VTE and reduction in the risk of recurrent VTE in paediatric patients from birth to less than 18 years 

• Thromboprophylaxis in paediatric patients 2 years and older with congenital heart disease after the Fontan procedure

Clinical Trials Analysis⁵

Xarelto has a total of 583 trials, including 264 industry trials of which 139 are interventional, 125 observational & no expanded access trials. The analysis of industry trials through a representation is shown below (Trials are taken as of 16 Nov 2022)

*Active trials include Recruiting; Active, Not Recruiting; Enrolling by Invitation, and suspended

*Inactive trials include Terminated; Withdrawn; Unknown Status

Janssen CarePath Savings Program⁶

Janssen CarePath helps patients verify insurance coverage and provides reimbursement information that helps them to find financial assistance options. Janssen CarePath program provides several benefits for the patients: 

Conduct health plan coverage review

Help identify financial assistance options for eligible patients
Provide care coordination with a treatment provider or pharmacy
Provide patient support resources

Program requirements 

• This program is only for people using commercial or private health insurance for their Janssen medication.

• Patients may not seek payment for the value received from this program from any health plan, patient assistance foundation, flexible spending account, or healthcare savings account.

• Patients must meet the program requirements every time they use the card.

• Program terms will expire at the end of each calendar year. The program may change or end without notice, including in specific states. 

• To use this program, patients must follow any health plan requirements, including telling their health plan how much co-payment support they get from this program. 

 • This program offer may not be used with any other coupon, discount, prescription savings card, free trial, or other offers. 

Janssen CarePath Provider Portal

Janssen CarePath Provider Portal is developed in collaboration with IBM Watson Health. The Provider Portal provides 24-hour online access to enrol not only eligible but also commercially insured patients in the Janssen CarePath Savings Program. It helps them to view and manage their Savings Program benefits

Savings and Support for Xarelto

Patients are eligible for Janssen CarePath Savings Program if:

 • Use commercial or private health insurance for XARELTO

 • Are being treated with XARELTO, except if prescribed XARELTO 10 mg because of a recent non-surgical hospital discharge or a recent undergone hip or knee replacement surgery.

Janssen Select

Janssen Select helps patients to stay on treatment when their out-of-pocket costs increase during a coverage gap (e.g., commercial high deductibles or the Medicare Part D coverage gap). 

Through Janssen Select patients can:

Pay $85, plus sales tax if applicable, for a 30-day (1-month) supply of Xarelto.

Or pay $240 for a 90-day (3-month) supply of Xarelto ($80 per month), plus sales tax if applicable, if the patient and the doctor choose a 90-day supply.
Patients can participate without paying a membership fee or sharing their income information. This program can help those who may not have qualified for affordability support in the past.
Patients can get additional support from Janssen CarePath to help patients to start and stay on therapy through JanssenCarePath.com, or patients can call 888-927-3586 from Monday–Friday, 8:00 am–8:00 pm ET.

Other information:

Patents⁷

Patents are a key determinant of market exclusivity for most branded pharmaceuticals. A drug patent is assigned by the U.S. Patent and Trademark Office which assigns the exclusive legal right to the patent holder to protect the proprietary chemical formulation. Xarelto has 157 International patents and 5 US patents.

Given below are some of the patent infringements for Xarelto in 2021:

1. In March 2021, Janssen and Bayer filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Lupin Limited and Lupin Pharma which filed an ANDA seeking approval to market a generic version of XARELTO before the expiration of U.S. Patent No. 10,828,310 (’310). 

2. In May 2021, JPI and Bayer filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. which filed an ANDA seeking approval to market a generic version of XARELTO before the expiration of the ’310 patent. 

3. In July 2021, JPI and Bayer filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Taro Pharmaceutical Industries which filed an ANDA seeking approval to market a generic version of XARELTO before the expiration of the ’310 patent. 

4. In July 2021, JPI and Bayer filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Teva Pharmaceuticals which filed an ANDA seeking approval to market a generic version of XARELTO before the expiration of the ’310 patent. 

Exclusivity

Exclusivity is a period of time when a brand-name drug is protected from generic drug competition. It is a statutory provision and is granted to an NDA applicant if statutory requirements are met. Some of the exclusivity expiration dates of Xarelto include:

1. Apr 11, 2023 - Paediatric exclusivity

2. Aug 23, 2024 - Major thrombotic vascular events 

3. February 23, 2025 - Paediatric exclusivity

4. June 20, 2025 - Paediatric exclusivity

Xarelto Competitors

Below mentioned is a comparative view of the competitors for Xarelto that are used for the treatment of cardiovascular diseases.