1.Product Overview

Product Name	Rivaroxaban Tablets, USP
Reference Listed Drug (RLD)	Xarelto®(Janssen)
Pharmaceutical Form	Film-coated tablet
Strength	10 mg, 15 mg, 20 mg

2.Indications and Usage

Rivaroxaban is a Factor Xa (FXa) inhibitor indicated for:

Nonvalvular Atrial Fibrillation (NVAF)	Reduction of the risk of stroke and systemic embolism in adult patients
Treatment of Deep Vein Thrombosis (DVT)	Treatment of DVT in adult patients
Treatment of Pulmonary Embolism (PE)	Treatment of PE in adult patients.
Reduction in Risk of Recurrence of DVT and/or PE	In adult patients at continued risk for recurrent DVT and/or PE.
Prophylaxis of DVT (Post-Surgery)	Prophylaxis of DVT in adult patients following hip replacement or knee replacement surgery.
Chronic Coronary Artery Disease (CAD) / Peripheral Artery Disease (PAD)	Reduction of the risk of major cardiovascular events (CV death, Myocardial Infarction, and stroke) in adult patients.

3.Dosage and Administration

Important Administration Instructions:

15 mg and 20 mg tablets	Must be taken with food (specifically, with the evening meal for NVAF).
10 mg and 2.5 mg tablets	Can be taken with or without food.

Dosage adjustments are required for patients with renal impairment (based on CrCl).

Standard Adult Dosing:

Indication	Dosage	Duration
Nonvalvular Atrial Fibrillation (NVAF)	20 mg once daily (with evening meal)	Long-term
Treatment of DVT / PE	Initial: 15 mg twice daily (with food)	21 days As indicated
	Maintenance: 20 mg once daily (with food)	As indicated
Prophylaxis of DVT (Hip/Knee)	10 mg once daily	Varies (e.g., 35 days post-hip, 12 days post-knee)
CAD / PAD	2.5 mg twice daily (in combination with low-dose aspirin)	Long-term

4.Comparison of Direct Oral Anticoagulants (DOACs)

Feature	Rivaroxaban	Apixaban	Dabigatran	Edoxaban
Mechanism of Action	Direct Factor Xa Inhibitor	Direct Factor Xa Inhibitor	Direct Thrombin (IIa) Inhibitor	Direct Factor Xa Inhibitor
Standard Dosing (for NVAF)	20 mg Once Daily	5 mg Twice Daily	150 mg Twice Daily	60 mg Once Daily
Food Requirement (High Dose)	Must be taken with food (15 mg & 20 mg tablets)	No food requirement.	No food requirement (capsule must not be opened/crushed).	No food requirement.
Key Differentiator	Once-daily dosing for NVAF and VTE maintenance. Requires food for high-dose absorption.	Twice-daily dosing. Considered by some studies to have a favorable GI bleeding profile.	Twice-daily dosing. The only direct thrombin inhibitor in oral form.	Once-daily dosing. Requires 5-10 days of parenteral (e.g., heparin) lead-in for acute VTE treatment.

5.Advantages of SPH Rivaroxaban Tablets

Cost-Effectiveness	Significantly reduces the treatment cost compared to the brand-name drug (Xarelto®), making long-term anticoagulation therapy more accessible and sustainable for patients and healthcare systems.
Therapeutic Equivalence (A-Rated)	As an FDA-approved generic (ANDA 216995), it is bioequivalent to Xarelto®, guaranteeing the same high standards of safety, efficacy, and pharmacological performance.
cGMP Manufacturing Standards	Manufactured in strict accordance with the FDA's Current Good Manufacturing Practices (cGMP), ensuring consistent product quality, purity, and potency.