OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Epclusa

Velpatasvir and Sofosbuvir · Pellet

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Epclusa
Generic name
Velpatasvir and Sofosbuvir
Dosage form
Pellet
Route
Oral
Marketing category
NDA · NDA
Labeler
Gilead Sciences, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Sofosbuvir 150 mg/1 1484916 View
Sofosbuvir 200 mg/1 1484916 View
Velpatasvir 37.5 mg/1 1799212 View
Velpatasvir 50 mg/1 1799212 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Pellet
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Breast Cancer Resistance Protein Inhibitors [MoA] MoA All 44 members
Hepatitis C Virus NS5A Inhibitor [EPC] EPC 4 members — no class page
Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC] EPC 6 members — no class page
Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA] MoA All 19 members
Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA] MoA All 10 members
Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA] MoA 4 members — no class page
P-Glycoprotein Inhibitors [MoA] MoA All 105 members
RNA Replicase Inhibitors [MoA] MoA 6 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
214187
Application type
NDA · New Drug Application
Approval date
June 10, 2021
Sponsor
GILEAD SCIENCES INC
Products on application
2
Submissions recorded
2
Products approved under application 214187.
Product Trade name Form Strength Ingredient Status TE Flags
214187-001 EPCLUSA PELLETS SOFOSBUVIR; VELPATASVIR Prescription — RLD
214187-002 EPCLUSA PELLETS SOFOSBUVIR; VELPATASVIR Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8580765 March 21, 2028 001 Yes U-1470 June 29, 2021
8334270 March 21, 2028 001 Yes U-1470 June 29, 2021
8735372 March 21, 2028 001 No U-1470 June 29, 2021
9085573 March 21, 2028 001 Yes U-1470 June 29, 2021
8334270 March 21, 2028 002 Yes U-1470 June 29, 2021
8580765 March 21, 2028 002 Yes U-1470 June 29, 2021
8735372 March 21, 2028 002 No U-1470 June 29, 2021
9085573 March 21, 2028 002 Yes U-1470 June 29, 2021
8334270*PED September 21, 2028 001 No —
8580765*PED September 21, 2028 001 No —
8735372*PED September 21, 2028 001 No —
9085573*PED September 21, 2028 001 No —
8334270*PED September 21, 2028 002 No —
8580765*PED September 21, 2028 002 No —
8735372*PED September 21, 2028 002 No —
9085573*PED September 21, 2028 002 No —
7964580 March 26, 2029 001 Yes U-1470 June 29, 2021
8889159 March 26, 2029 001 No U-1470 June 29, 2021
8633309 March 26, 2029 001 Yes U-1470 June 29, 2021
7964580 March 26, 2029 002 Yes U-1470 June 29, 2021
8889159 March 26, 2029 002 No U-1470 June 29, 2021
8633309 March 26, 2029 002 Yes U-1470 June 29, 2021
7964580*PED September 26, 2029 001 No —
8889159*PED September 26, 2029 001 No —
8633309*PED September 26, 2029 001 No —
7964580*PED September 26, 2029 002 No —
8889159*PED September 26, 2029 002 No —
8633309*PED September 26, 2029 002 No —
9284342 September 13, 2030 001 Yes U-1470 June 29, 2021
9284342 September 13, 2030 002 Yes U-1470 June 29, 2021
8618076 December 11, 2030 001 Yes U-1470 June 29, 2021
8618076 December 11, 2030 002 Yes U-1470 June 29, 2021
9284342*PED March 13, 2031 001 No —
9284342*PED March 13, 2031 002 No —
8618076*PED June 11, 2031 001 No —
8618076*PED June 11, 2031 002 No —
8575135 November 16, 2032 001 Yes U-1470 June 29, 2021
8921341 November 16, 2032 001 Yes U-1470 June 29, 2021
8940718 November 16, 2032 001 Yes U-1470 June 29, 2021
8575135 November 16, 2032 002 Yes U-1470 June 29, 2021
8921341 November 16, 2032 002 Yes U-1470 June 29, 2021
8940718 November 16, 2032 002 Yes U-1470 June 29, 2021
8575135*PED May 16, 2033 001 No —
8921341*PED May 16, 2033 001 No —
8940718*PED May 16, 2033 001 No —
8575135*PED May 16, 2033 002 No —
8921341*PED May 16, 2033 002 No —
8940718*PED May 16, 2033 002 No —
11116783 January 30, 2034 001 No U-1470 October 1, 2021
11707479 January 30, 2034 001 No U-1470 August 15, 2023
11116783 January 30, 2034 002 No U-1470 October 1, 2021
11707479 January 30, 2034 002 No U-1470 August 15, 2023
11116783*PED July 30, 2034 001 No —
11707479*PED July 30, 2034 001 No —
11116783*PED July 30, 2034 002 No —
11707479*PED July 30, 2034 002 No —
Regulatory exclusivity periods.
Code Expires Product
ODE* March 19, 2027 002
PED September 19, 2027 002
ODE-376 June 10, 2028 001
PED December 10, 2028 001

Approval history

Source: Drugs@FDA
Most recent submissions on application 214187.
Type No. Action Status Date Review
Supplement 1 Efficacy Approved April 27, 2022 Standard
Original application 1 Type 3 - New Dosage Form Approved June 10, 2021 Priority

Review documents

  • 0 · Supplement · April 29, 2022
  • 0 · Supplement · April 28, 2022
  • 0 · Original application · November 29, 2021
  • 0 · Original application · June 14, 2021
  • 0 · Original application · June 11, 2021

Adverse event reports

Source: openFDA FAERS
52,335
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SOFOSBUVIR. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
61958-2204-1 61958-2204 Gilead Sciences, Inc. 28 PACKET in 1 CARTON (61958-2204-1) / 1 PELLET in 1 PACKET June 10, 2021
61958-2205-1 61958-2205 Gilead Sciences, Inc. 28 PACKET in 1 CARTON (61958-2205-1) / 1 PELLET in 1 PACKET June 10, 2021
61958-2204 61958-2204 Gilead Sciences, Inc. — June 10, 2021
61958-2205 61958-2205 Gilead Sciences, Inc. — June 10, 2021

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.