Viewing data from:

KALYDECO

NDA

IVACAFTOR | N203188 | VERTEX PHARMACEUTICALS INC

1 strength9 unique patents2 unique exclusivities

Patent Timeline

9 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (5)Active (4)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

Today

Nov. 20, 2027

Feb. 5, 2028

Jan. 6, 2027

Jun. 28, 2027

Jun. 28, 2027

Jun. 28, 2027

Feb. 13, 2030

Feb. 13, 2030

Feb. 13, 2030

ODE-338

Jun. 21, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Vertex Pharmaceuticals Incorporated v. MSN Pharmaceuticals Inc. et al 1:2026cv00306 3 patentsANDA 221339ivacaftor	D. Del.	2026-03-20	Active	—
Vertex Pharmaceuticals Incorporated v. Sun Pharmaceutical Industries Limited 1:2023cv00666 2 patentsANDA 214027ivacaftor	D. Del.	2023-06-16	Terminated 2024-01-02	—
Vertex Pharmaceuticals Incorporated v. Sun Pharmaceutical Industries Limited, et al. 1:2020cv00988 1 patentANDA 214027ivacaftor	D. Del.	2020-07-24	Terminated 2024-01-02	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Kalydeco (2023)

Total Spending

$25.1M

Total Claims

936

Beneficiaries

Avg Cost/Unit

$480.25

Spending Trend

$58.4M(2019)→$37.7M(2020)→$25.9M(2021)→$25.5M(2022)→$25.1M(2023)

YoY Change:+2.1%

5yr CAGR:+2.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain14 active DMFs

13 active API suppliers hold Drug Master Files for this ingredient.

ALIVUS LIFE SCIENCES LTDIVACAFTOR

DMF 288672015

MSN LABORATORIES PRIVATE LTDIVACAFTOR [ROUTE CODE - 'IC']

DMF 293982015

ALEMBIC PHARMACEUTICALS LTDIVACAFTOR

DMF 318492017

LUPIN MANUFACTURING SOLUTIONS LTDIVACAFTOR

DMF 326102019

SUN PHARMACEUTICAL INDUSTRIES LTDIVACAFTOR

DMF 337832019

SCINOPHARM TAIWAN LTDIVACAFTOR

DMF 354472020

APITORIA PHARMA PRIVATE LTDIVACAFTOR

DMF 360942021

APITORIA PHARMA PRIVATE LTDIVACAFTOR PREMIX

DMF 362092021

CIPLA LTDIVACAFTOR

DMF 394772024

MEDICHEM SAIVACAFTOR

DMF 408422024

BIOCON LTDIVACAFTOR

DMF 413452025

HETERO LABS LTDIVACAFTOR PREMIX

DMF 414062025

MAITHRI DRUGS PRIVATE LTDIVACAFTOR

DMF 428582025

ZYDUS LIFESCIENCES LTDIVACAFTOR

DMF 432612025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

20 letters from Drugs@FDA

Date	Submission	Document
Mar 19, 2026	SUPPL -44	View Letter (PDF)
Sep 26, 2025	SUPPL -42	View Letter (PDF)
May 27, 2025	SUPPL -41	View Letter (PDF)
Aug 4, 2023	SUPPL -40	View Letter (PDF)
May 4, 2023	SUPPL -38	View Letter (PDF)
Dec 23, 2020	SUPPL -34	View Letter (PDF)
Sep 25, 2020	SUPPL -33	View Letter (PDF)
Apr 30, 2019	SUPPL -29	View Letter (PDF)
Aug 20, 2018	SUPPL -28	View Letter (PDF)
Aug 2, 2017	SUPPL -26	View Letter (PDF)
May 18, 2017	SUPPL -19	View Letter (PDF)
Feb 9, 2017	SUPPL -22	View Letter (PDF)
Mar 6, 2015	SUPPL -17	View Letter (PDF)
Jan 6, 2015	SUPPL -14	View Letter (PDF)
Jan 6, 2015	SUPPL -15	View Letter (PDF)
Jun 18, 2014	SUPPL -7	View Letter (PDF)
Apr 10, 2014	SUPPL -8	View Letter (PDF)
Feb 25, 2014	SUPPL -4	View Letter (PDF)
Aug 29, 2012	SUPPL -1	View Letter (PDF)
Jan 31, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG

RLD

9 patents2 exclusivities▴

TABLET;ORAL | Approved: Jan 31, 2012

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7495103	May 20, 2027PED: Nov 20, 2027	PED	Yes	Yes	—	—
8324242	Aug 5, 2027PED: Feb 5, 2028	PED	—	—		—
8354427	Jul 6, 2026PED: Jan 6, 2027	PED	—	—		—
8410274	Dec 28, 2026PED: Jun 28, 2027	PED	—	Yes	—	—
8754224	Dec 28, 2026PED: Jun 28, 2027	PED	Yes	Yes	—	—
9670163	Dec 28, 2026PED: Jun 28, 2027	PED	—	Yes		—
10646481	Aug 13, 2029PED: Feb 13, 2030	PED	—	Yes	—	—
11564916	Aug 13, 2029PED: Feb 13, 2030	PED	—	—		—
12458635	Aug 13, 2029PED: Feb 13, 2030	PED	—	Yes		—

Exclusivities (2)

Code	Date	Status
ODE-338	Dec 21, 2027	Active
PED	Jun 21, 2028	Active