Viewing data from:

LORBRENA

NDA

LORLATINIB | N210868 | PFIZER INC

2 strengths4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Mar. 5, 2033

Jul. 27, 2036

Jul. 27, 2036

Oct. 4, 2038

ODE-349

Mar. 3, 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 2 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC NCT07671560	Phase 4	Not Yet Recruiting	Qiming Wang	80	2026-07-01 → 2028-12-31
Rucaparib Monoclonal Antibody for Lorlatinib-Induced Hypercholesterolemia / Mixed NCT07674368	Phase 4	Not Yet Recruiting	Hunan Cancer Hospital	29	2026-07-10 → 2028-08-01
A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer (NSCLC) Which Has Spread Out.NCT06678555	—	Completed	Pfizer	35	2025-07-04 → 2026-04-14

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

Medicare Part D Spending

CMS annual spending data for Lorbrena (2023)

Total Spending

$75.6M

Total Claims

3,791

Beneficiaries

605

Avg Cost/Unit

$492.21

Spending Trend

$20.2M(2019)→$31.4M(2020)→$42.6M(2021)→$61.9M(2022)→$75.6M(2023)

YoY Change:+6.6%

5yr CAGR:+3.9%

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jan 30, 2026	SUPPL -8	View Letter (PDF)
Sep 30, 2025	SUPPL -6	View Letter (PDF)
Mar 4, 2021	SUPPL -4	View Letter (PDF)
Mar 2, 2021	SUPPL -3	View Letter (PDF)
Jan 26, 2021	SUPPL -2	View Letter (PDF)
Jun 2, 2020	SUPPL -1	View Letter (PDF)
Nov 13, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 25MG

RLD

4 patents1 exclusivity▴

TABLET;ORAL | Approved: Nov 2, 2018

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8680111	Mar 5, 2033	—	Yes	Yes	—	—
10420749	Jul 27, 2036	—	Yes	Yes		—
11020376	Jul 27, 2036	—	—	Yes	—	—
11299500	Oct 4, 2038	—	Yes	—	—	—

Exclusivities (1)

Code	Date	Status
ODE-349	Mar 3, 2028	Active

#002 — 100MG

RLD

4 patents1 exclusivity▾

TABLET;ORAL | Approved: Nov 2, 2018