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ORKAMBI

lumacaftor and ivacaftor · Tablet, Film Coated

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
ORKAMBI
Generic name
lumacaftor and ivacaftor
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Vertex Pharmaceuticals Incorporated
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
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
Ivacaftor 125 mg/1 1655928 View
Lumacaftor 100 mg/1 1655928 View
Lumacaftor 200 mg/1 1655928 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
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
Chloride Channel Activation Potentiators [MoA] MoA 4 members — no class page
Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC] EPC 4 members — no class page
Cytochrome P450 2B6 Inducers [MoA] MoA All 44 members
Cytochrome P450 2C19 Inducers [MoA] MoA All 37 members
Cytochrome P450 2C8 Inducers [MoA] MoA All 21 members
Cytochrome P450 2C8 Inhibitors [MoA] MoA All 56 members
Cytochrome P450 2C9 Inducers [MoA] MoA All 46 members
Cytochrome P450 2C9 Inhibitors [MoA] MoA All 34 members
Cytochrome P450 3A Inducers [MoA] MoA All 37 members
Cytochrome P450 3A Inhibitors [MoA] MoA All 89 members
P-Glycoprotein Inducers [MoA] MoA 4 members — no class page
P-Glycoprotein Inhibitors [MoA] MoA All 105 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
206038
Application type
NDA · New Drug Application
Approval date
July 2, 2015
Sponsor
VERTEX PHARMS INC
Products on application
2
Submissions recorded
14
Products approved under application 206038.
Product Trade name Form Strength Ingredient Status TE Flags
206038-001 ORKAMBI TABLET IVACAFTOR; LUMACAFTOR Prescription — RLD RS
206038-002 ORKAMBI TABLET IVACAFTOR; LUMACAFTOR Prescription — RLD

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
7973038 November 8, 2026 001 No U-1973 October 21, 2016
8741933 November 8, 2026 001 No U-1909 July 22, 2015
8741933 November 8, 2026 001 No U-1717 July 22, 2015
9216969 November 8, 2026 001 Yes March 15, 2016
7973038 November 8, 2026 002 No U-1973 October 21, 2016
8741933 November 8, 2026 002 No U-1909 October 21, 2016
9216969 November 8, 2026 002 No October 21, 2016
9670163 December 28, 2026 001 No U-1911 July 5, 2017
9931334 December 28, 2026 001 No U-2276 May 2, 2018
8754224 December 28, 2026 001 Yes July 22, 2015
8410274 December 28, 2026 001 No July 22, 2015
9931334 December 28, 2026 002 No U-2276 May 2, 2018
9670163 December 28, 2026 002 No U-1911 July 5, 2017
8754224 December 28, 2026 002 Yes October 21, 2016
8410274 December 28, 2026 002 No October 21, 2016
8741933*PED May 8, 2027 001 No —
9216969*PED May 8, 2027 001 No —
7973038*PED May 8, 2027 001 No —
9216969*PED May 8, 2027 002 No —
8741933*PED May 8, 2027 002 No —
7973038*PED May 8, 2027 002 No —
7495103 May 20, 2027 001 Yes July 22, 2015
7495103 May 20, 2027 002 Yes October 21, 2016
9670163*PED June 28, 2027 001 No —
9931334*PED June 28, 2027 001 No —
8410274*PED June 28, 2027 001 No —
8754224*PED June 28, 2027 001 No —
8410274*PED June 28, 2027 002 No —
8754224*PED June 28, 2027 002 No —
9670163*PED June 28, 2027 002 No —
9931334*PED June 28, 2027 002 No —
8324242 August 5, 2027 001 No U-1311 July 22, 2015
8324242 August 5, 2027 001 No U-1911 July 22, 2015
8324242 August 5, 2027 002 No U-1911 October 21, 2016
7495103*PED November 20, 2027 001 No —
7495103*PED November 20, 2027 002 No —
8324242*PED February 5, 2028 001 No —
8324242*PED February 5, 2028 002 No —
9150552 December 4, 2028 001 No U-1908 October 21, 2016
10076513 December 4, 2028 001 No U-2411 October 18, 2018
10597384 December 4, 2028 001 Yes U-2777 April 23, 2020
12065432 December 4, 2028 001 No U-3984 September 18, 2024
11052075 December 4, 2028 001 No U-3181 August 4, 2021
8653103 December 4, 2028 001 No July 22, 2015
9150552 December 4, 2028 002 No U-1908 October 21, 2016
10597384 December 4, 2028 002 Yes U-2777 April 23, 2020
12065432 December 4, 2028 002 No U-3984 September 18, 2024
11052075 December 4, 2028 002 No U-3181 August 4, 2021
8653103 December 4, 2028 002 No October 21, 2016
9150552*PED June 4, 2029 001 No —
8653103*PED June 4, 2029 001 No —
10076513*PED June 4, 2029 001 No —
11052075*PED June 4, 2029 001 No —
12065432*PED June 4, 2029 001 No —
10597384*PED June 4, 2029 001 No —
8653103*PED June 4, 2029 002 No —
9150552*PED June 4, 2029 002 No —
11052075*PED June 4, 2029 002 No —
12065432*PED June 4, 2029 002 No —
10597384*PED June 4, 2029 002 No —
8846718 July 2, 2029 001 No U-1717 July 22, 2015
8846718 July 2, 2029 001 No U-1908 July 22, 2015
8846718 July 2, 2029 002 No U-1908 October 21, 2016
12458635 August 13, 2029 001 No U-4338 November 26, 2025
11564916 August 13, 2029 001 No U-3529 February 28, 2023
10646481 August 13, 2029 001 No June 11, 2020
12458635 August 13, 2029 002 No U-4338 November 26, 2025
11564916 August 13, 2029 002 No U-3529 February 28, 2023
10646481 August 13, 2029 002 No June 11, 2020
9192606 September 29, 2029 001 No U-1912 October 21, 2016
9192606 September 29, 2029 002 No U-1912 October 21, 2016
8846718*PED January 2, 2030 001 No —
8846718*PED January 2, 2030 002 No —
10646481*PED February 13, 2030 001 No —
12458635*PED February 13, 2030 001 No —
11564916*PED February 13, 2030 001 No —
10646481*PED February 13, 2030 002 No —
12458635*PED February 13, 2030 002 No —
11564916*PED February 13, 2030 002 No —
9192606*PED March 29, 2030 001 No —
9192606*PED March 29, 2030 002 No —
8716338 September 20, 2030 001 No U-1718 July 22, 2015
8716338 September 20, 2030 001 No U-1910 July 22, 2015
8507534 September 20, 2030 001 Yes July 22, 2015
8716338 September 20, 2030 002 No U-1910 October 21, 2016
8507534 September 20, 2030 002 Yes October 21, 2016
8993600 December 11, 2030 001 No July 22, 2015
8993600 December 11, 2030 002 No October 21, 2016
8507534*PED March 20, 2031 001 No —
8716338*PED March 20, 2031 001 No —
8507534*PED March 20, 2031 002 No —
8716338*PED March 20, 2031 002 No —
8993600*PED June 11, 2031 001 No —
8993600*PED June 11, 2031 002 No —

Approval history

Source: Drugs@FDA
Most recent submissions on application 206038.
Type No. Action Status Date Review
Supplement 20 Labeling Approved March 17, 2026 Standard
Supplement 19 Labeling Approved September 25, 2025 Standard
Supplement 18 Efficacy Approved December 13, 2024 Priority
Supplement 17 Labeling Approved August 3, 2023 Standard
Supplement 16 Labeling Approved September 2, 2022 Standard
Supplement 10 Labeling Approved August 15, 2018 Standard
Supplement 7 Efficacy Approved January 25, 2018 Standard
Supplement 5 Efficacy Approved September 28, 2016 Priority
Supplement 6 Labeling Approved September 6, 2016 Standard
Supplement 4 Manufacturing (CMC) Approved August 5, 2016 Standard
Supplement 1 Labeling Approved May 18, 2016 Standard
Supplement 3 Manufacturing (CMC) Approved April 6, 2016 Priority
Supplement 2 Manufacturing (CMC) Approved March 18, 2016 Priority
Original application 1 Type 1 - New Molecular Entity Approved July 2, 2015 Priority

Review documents

  • 0 · Supplement · March 24, 2026
  • 0 · Supplement · March 19, 2026
  • 0 · Supplement · September 26, 2025
  • 0 · Supplement · September 26, 2025
  • 0 · Supplement · December 16, 2024
  • 0 · Supplement · December 16, 2024
  • 0 · Supplement · August 4, 2023
  • 0 · Supplement · August 4, 2023
  • 0 · Supplement · September 7, 2022
  • 0 · Supplement · September 6, 2022
  • 0 · Supplement · August 20, 2018
  • 0 · Supplement · August 17, 2018
  • 0 · Supplement · February 6, 2018
  • 0 · Supplement · January 30, 2018
  • 0 · Supplement · February 22, 2017
  • 0 · Supplement · September 30, 2016
  • 0 · Supplement · September 7, 2016
  • 0 · Supplement · May 20, 2016
  • 0 · Supplement · May 20, 2016
  • 0 · Original application · August 7, 2015
  • 0 · Original application · August 7, 2015
  • 0 · Original application · July 2, 2015
  • 0 · Original application · July 2, 2015

Adverse event reports

Source: openFDA FAERS
33,954
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: IVACAFTOR. 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
51167-700-02 51167-700 Vertex Pharmaceuticals Incorporated 4 CARTON in 1 BOX (51167-700-02) / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK September 28, 2016
51167-809-01 51167-809 Vertex Pharmaceuticals Incorporated 4 CARTON in 1 BOX (51167-809-01) / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK July 2, 2015
51167-700 51167-700 Vertex Pharmaceuticals Incorporated — September 28, 2016
51167-809 51167-809 Vertex Pharmaceuticals Incorporated — July 2, 2015

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.