Viewing data from:

BALVERSA

NDA

ERDAFITINIB | N212018 | JANSSEN BIOTECH INC

3 strengths8 unique patents1 unique exclusivity

Patent Timeline

8 unique patents, 1 exclusivity by expiration date

Active (8)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

Apr. 12, 2033

Apr. 28, 2031

Mar. 26, 2035

Aug. 13, 2036

Feb. 9, 2036

Feb. 2, 2038

Feb. 9, 2036

Oct. 18, 2035

I-930

Jan. 19, 2027

PTAB Proceedings

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

Patent Reexaminations

1 reexamination on OB patents from USPTO Patent Center

96/050,010Ex PartePending

Patent: 11077106Filed: 2022-12-13

CANCER TREATMENT

Recent Events

2024-04-11RXRLFLitigation Found

2024-04-11RXLITSRLitigation Search Conducted

Source: USPTO Patent Center. Ex parte and inter partes reexamination proceedings.

Hatch-Waxman Litigation

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
JANSSEN PHARMACEUTICA NV et al v. NATCO PHARMA LTD. 2:2025cv16648 2 patentsANDA 218578erdafitinib	D.N.J.	2025-10-15	Active	—

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 Balversa (2023)

Total Spending

$17.7M

Total Claims

852

Beneficiaries

275

Avg Cost/Unit

$445.75

Spending Trend

$8.2M(2019)→$15.9M(2020)→$15.0M(2021)→$16.8M(2022)→$17.7M(2023)

YoY Change:+7.6%

5yr CAGR:+4.9%

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Oct 21, 2025	SUPPL -11	View Letter (PDF)
Oct 10, 2024	SUPPL -10	View Letter (PDF)
Jan 23, 2024	SUPPL -7	View Letter (PDF)
Jan 23, 2024	SUPPL -9	View Letter (PDF)
Jan 23, 2024	SUPPL -8	View Letter (PDF)
Mar 21, 2023	SUPPL -5	View Letter (PDF)
Jan 12, 2023	SUPPL -4	View Letter (PDF)
Apr 29, 2022	SUPPL -2	View Letter (PDF)
Apr 29, 2022	SUPPL -3	View Letter (PDF)
Apr 3, 2020	SUPPL -1	View Letter (PDF)
Apr 15, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 3MG

RLD

8 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 12, 2019

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8895601	Apr 12, 2033	—	Yes	Yes	—	—
9464071	Apr 28, 2031	—	—	—		—
9902714	Mar 26, 2035	—	—	Yes	—	—
10478494	Aug 13, 2036	—	—	—		—
10898482	Feb 9, 2036	—	—	Yes		—
11077106	Feb 2, 2038	—	—	—		—
11684620	Feb 9, 2036	—	—	—		—
12037644	Oct 18, 2035	—	—	—		—

Exclusivities (1)

Code	Date	Status
I-930	Jan 19, 2027	< 1 year

#002 — 4MG

RLD

8 patents1 exclusivity▾

TABLET;ORAL | Approved: Apr 12, 2019

#003 — 5MG

RLD

8 patents1 exclusivity▾

TABLET;ORAL | Approved: Apr 12, 2019