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Harvoni

ledipasvir 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
Harvoni
Generic name
ledipasvir 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
Ledipasvir 33.75 mg/1 1591943 View
Ledipasvir 45 mg/1 1591943 View
Sofosbuvir 150 mg/1 1484916 View
Sofosbuvir 200 mg/1 1484916 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
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
212477
Application type
NDA · New Drug Application
Approval date
August 28, 2019
Sponsor
GILEAD SCIENCES INC
Products on application
2
Submissions recorded
6
Products approved under application 212477.
Product Trade name Form Strength Ingredient Status TE Flags
212477-001 HARVONI PELLETS LEDIPASVIR; SOFOSBUVIR Prescription — RLD
212477-002 HARVONI PELLETS LEDIPASVIR; SOFOSBUVIR 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 September 23, 2019
8334270 March 21, 2028 001 Yes U-1470 September 23, 2019
8735372 March 21, 2028 001 No U-1470 September 23, 2019
9085573 March 21, 2028 001 Yes U-1470 September 23, 2019
8580765 March 21, 2028 002 Yes U-1470 September 23, 2019
8334270 March 21, 2028 002 Yes U-1470 September 23, 2019
8735372 March 21, 2028 002 No U-1470 September 23, 2019
9085573 March 21, 2028 002 Yes U-1470 September 23, 2019
8580765*PED September 21, 2028 001 No —
8334270*PED September 21, 2028 001 No —
8735372*PED September 21, 2028 001 No —
9085573*PED September 21, 2028 001 No —
8580765*PED September 21, 2028 002 No —
8334270*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 September 23, 2019
8633309 March 26, 2029 001 Yes U-1470 September 23, 2019
8889159 March 26, 2029 001 No U-1470 September 23, 2019
7964580 March 26, 2029 002 Yes U-1470 September 23, 2019
8633309 March 26, 2029 002 Yes U-1470 September 23, 2019
8889159 March 26, 2029 002 No U-1470 September 23, 2019
7964580*PED September 26, 2029 001 No —
8633309*PED September 26, 2029 001 No —
8889159*PED September 26, 2029 001 No —
7964580*PED September 26, 2029 002 No —
8633309*PED September 26, 2029 002 No —
8889159*PED September 26, 2029 002 No —
8273341 May 12, 2030 001 No U-1470 September 23, 2019
8822430 May 12, 2030 001 Yes U-1470 September 23, 2019
8841278 May 12, 2030 001 No U-1470 September 23, 2019
9511056 May 12, 2030 001 No U-1470 September 23, 2019
8088368 May 12, 2030 001 Yes September 23, 2019
8273341 May 12, 2030 002 No U-1470 September 23, 2019
8841278 May 12, 2030 002 No U-1470 September 23, 2019
8822430 May 12, 2030 002 Yes U-1470 September 23, 2019
9511056 May 12, 2030 002 No U-1470 September 23, 2019
8088368 May 12, 2030 002 Yes September 23, 2019
9284342 September 13, 2030 001 Yes U-1470 September 23, 2019
9284342 September 13, 2030 002 Yes U-1470 September 23, 2019
8273341*PED November 12, 2030 001 No —
8088368*PED November 12, 2030 001 No —
8822430*PED November 12, 2030 001 No —
8841278*PED November 12, 2030 001 No —
9511056*PED November 12, 2030 001 No —
8273341*PED November 12, 2030 002 No —
8088368*PED November 12, 2030 002 No —
8841278*PED November 12, 2030 002 No —
8822430*PED November 12, 2030 002 No —
9511056*PED November 12, 2030 002 No —
8618076 December 11, 2030 001 Yes U-1470 September 23, 2019
8618076 December 11, 2030 002 Yes U-1470 September 23, 2019
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 —
9393256 September 14, 2032 001 No U-1470 September 23, 2019
10456414 September 14, 2032 001 No November 20, 2019
9393256 September 14, 2032 002 No U-1470 September 23, 2019
10456414 September 14, 2032 002 No November 20, 2019
9393256*PED March 14, 2033 001 No —
9393256*PED March 14, 2033 002 No —
Regulatory exclusivity periods.
Code Expires Product
ODE-262 August 28, 2026 001
ODE-263 August 28, 2026 001
ODE-264 August 28, 2026 001
ODE-262 August 28, 2026 002
ODE-263 August 28, 2026 002
ODE-264 August 28, 2026 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 212477.
Type No. Action Status Date Review
Supplement 6 Labeling Approved December 19, 2024 Standard
Supplement 3 Labeling Approved March 5, 2020 Standard
Supplement 4 Labeling Approved December 4, 2019 Standard
Supplement 2 Efficacy Approved November 15, 2019 Standard
Supplement 1 Labeling Approved September 19, 2019 Standard
Original application 1 Type 3 - New Dosage Form Approved August 28, 2019 Priority

Review documents

  • 0 · Supplement · December 23, 2024
  • 0 · Supplement · December 20, 2024
  • 0 · Original application · April 27, 2020
  • 0 · Supplement · March 9, 2020
  • 0 · Supplement · March 6, 2020
  • 0 · Supplement · December 5, 2019
  • 0 · Supplement · November 19, 2019
  • 0 · Supplement · November 19, 2019
  • 0 · Supplement · September 20, 2019
  • 0 · Supplement · September 20, 2019
  • 0 · Original application · August 29, 2019
  • 0 · Original application · August 29, 2019

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
61958-1804-1 61958-1804 Gilead Sciences, Inc 120 PELLET in 1 PACKET (61958-1804-1) August 28, 2019
61958-1805-1 61958-1805 Gilead Sciences, Inc 90 PELLET in 1 PACKET (61958-1805-1) August 28, 2019
61958-1804 61958-1804 Gilead Sciences, Inc — August 28, 2019
61958-1805 61958-1805 Gilead Sciences, Inc — August 28, 2019

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.