Viewing data from:

ALECENSA

NDA

ALECTINIB HYDROCHLORIDE | N208434 | HOFFMANN-LA ROCHE INC

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

May. 29, 2031

Mar. 4, 2032

Jun. 9, 2030

Apr. 24, 2035

Apr. 24, 2035

I-947

Apr. 18, 2027

ODE-477

Apr. 18, 2031

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
GENENTECH, INC. et al v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 2:2025cv19019 8 patentsANDA 214274alectinib	D.N.J.	2025-12-29	Active	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms NCT05987956	Phase 2/3	Active	Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	600	2026-03-18 → 2026-12-28

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Alecensa (2023)

Total Spending

$186.0M

Total Claims

11,015

Beneficiaries

1,459

Avg Cost/Unit

$77.07

Spending Trend

$84.2M(2019)→$105.1M(2020)→$125.2M(2021)→$153.9M(2022)→$186.0M(2023)

YoY Change:+6.3%

5yr CAGR:+5.2%

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

API Supply Chain6 active DMFs1 inactive

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

MSN LABORATORIES PRIVATE LTDALECTINIB HYDROCHLORIDE

DMF 336372019

SUN PHARMACEUTICAL INDUSTRIES LTDALECTINIB HYDROCHLORIDE

DMF 341282019

NATCO PHARMA LTDALECTINIB HYDROCHLORIDE

DMF 369082022

HETERO LABS LTDALECTINIB HYDROCHLORIDE

DMF 393832024

PORTON PHARMA SOLUTIONS LTDALECTINIB HYDROCHLORIDE

DMF 400932024

SCINOPHARM TAIWAN LTDALECTINIB HYDROCHLORIDE

DMF 433172025

FRESENIUS KABI ONCOLOGY LTDInactiveALECTINIB HYDROCHLORIDE

DMF 338692019

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jun 15, 2026	SUPPL -16	View Letter (PDF)
Apr 19, 2024	SUPPL -15	View Letter (PDF)
Sep 8, 2021	SUPPL -12	View Letter (PDF)
Feb 2, 2021	SUPPL -10	View Letter (PDF)
Jun 14, 2018	SUPPL -4	View Letter (PDF)
Jun 14, 2018	SUPPL -4	View Letter (PDF)
Nov 9, 2017	SUPPL -3	View Letter (PDF)
Nov 8, 2016	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 150MG BASE

RLD

5 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Dec 11, 2015

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9126931	May 29, 2031	—	Yes	—	—	—
9365514	Mar 4, 2032	—	—	Yes	—	—
9440922	Jun 9, 2030	—	—	Yes	—	—
10350214	Apr 24, 2035	—	—	Yes	—	—
11433076	Apr 24, 2035	—	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
I-947	Apr 18, 2027	< 1 year
ODE-477	Apr 18, 2031	Active