Viewing data from:

BALVERSA

NDA

ERDAFITINIB | N212018 | JANSSEN BIOTECH INC

3 strengths9 unique patents1 unique exclusivity

Patent Timeline

9 unique patents, 1 exclusivity by expiration date

Active (9)TodayExclusivity

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

Jun. 13, 2036

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 ParteCertificate Issued

Patent: 11077106Filed: 2022-12-13Certificate: 2024-07-15

CANCER TREATMENT

Recent Events

2024-04-11RXLITSRLitigation Search Conducted

2023-02-27MSNQYSE Certificate — Substantial New Question Found

2022-12-13SEREQSupplemental Examination Request Filed

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

16 trials from ClinicalTrials.gov, 8 active, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment NCT05859334	Phase 2	Active	National Cancer Institute (NCI)	30	2024-01-04 → 2027-10-23
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)NCT03210714	Phase 2	Active	National Cancer Institute (NCI)	20	2018-06-05 → 2026-12-30
Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1)NCT06308822	Phase 2	Active	National Cancer Institute (NCI)	35	2018-08-20 → 2027-01-15
Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2)NCT06351371	Phase 2	Active	National Cancer Institute (NCI)	35	2018-07-03 → 2027-01-15
Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy NCT04963153	Phase 1	Active	National Cancer Institute (NCI)	24	2022-07-07 → 2026-12-01
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer NCT05567185	Phase 1	Active	Janssen Pharmaceutical K.K.	5	2023-03-03 → 2026-08-30
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer NCT05316155	Phase 1/2	Active	Janssen Research & Development, LLC	235	2022-04-11 → 2029-07-24
A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer NCT04917809	Phase 2	Active	Memorial Sloan Kettering Cancer Center	20	2022-02-17 → 2027-08
Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options NCT03825484	—	APPROVED_FOR_MARKETING	Janssen Scientific Affairs, LLC	—	—
A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants NCT03066687	Phase 1	Completed	Janssen Research & Development, LLC	16	2017-03-14 → 2017-05-12

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

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$10147.60

Highest Price

$31259.52

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59676-0030-56BALVERSA 3MG TAB	$15394.23	Big4	J & J Health Care Systems on behalf of Janssen Biotech Inc.	08/31/2029
59676-0030-56BALVERSA 3MG TAB	$20839.68	FSS	J & J Health Care Systems on behalf of Janssen Biotech Inc.	08/31/2029
59676-0030-84BALVERSA 3MG TAB	$22458.01	Big4	J & J Health Care Systems on behalf of Janssen Biotech Inc.	08/31/2029
59676-0030-84BALVERSA 3MG TAB	$31259.52	FSS	J & J Health Care Systems on behalf of Janssen Biotech Inc.	08/31/2029
59676-0040-28BALVERSA 4MG TAB	$10147.60	Big4	J & J Health Care Systems on behalf of Janssen Biotech Inc.	08/31/2029
59676-0040-28BALVERSA 4MG TAB	$13893.12	FSS	J & J Health Care Systems on behalf of Janssen Biotech Inc.	08/31/2029

Showing 6 of 10 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Balversa (2024)

Total Spending

$22.7M

Total Claims

1,123

Beneficiaries

305

Avg Cost/Unit

$443.00

Spending Trend

$8.2M(2019)→$15.9M(2020)→$15.0M(2021)→$16.8M(2022)→$17.7M(2023)→$22.7M(2024)

YoY Change:-0.6%

5yr CAGR:+4.3%

Source: CMS Medicare Part D Spending by Drug (2024). 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

18 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 12, 2019

Patents (18)

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		—
10898482	Feb 9, 2036	—	—	Yes		—
10898482	Feb 9, 2036	—	—	Yes		—
10898482	Feb 9, 2036	—	—	Yes		—
10898482	Feb 9, 2036	—	—	Yes		—
10898482	Feb 9, 2036	—	—	Yes		—
10898482	Feb 9, 2036	—	—	Yes		—
11077106	Feb 2, 2038	—	—	—		—
11077106	Feb 2, 2038	—	—	—		—
11684620	Feb 9, 2036	—	—	—		—
11684620	Feb 9, 2036	—	—	—		—
11684620	Feb 9, 2036	—	—	—		—
12037644	Oct 18, 2035	—	—	—		—
12678498	Jun 13, 2036	—	—	—		—

Exclusivities (1)

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

#002 — 4MG

RLD

18 patents1 exclusivity▾

TABLET;ORAL | Approved: Apr 12, 2019

#003 — 5MG

RLD

18 patents1 exclusivity▾

TABLET;ORAL | Approved: Apr 12, 2019