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Orange Book product · Brand (NDA)

Balversa

Erdafitinib

Brand (NDA)NDA 212018RLD Janssen Biotech
Approved
Apr 12, 2019
Application
Brand (NDA)
TE code
Not listed
Listed patents
17
Balversa (Erdafitinib) is Janssen Biotech's brand-name drug, approved by the FDA under NDA 212018 in 2019. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. The FDA Orange Book lists 17 patents against it, the last expiring 2038. 1 marketing-exclusivity period is recorded.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 12, 2019

    7 yr 5 mo ago

  2. Today

  3. Exclusivity ends · I-930

    New indication exclusivity (3 years)

    Jan 19, 2027

    in 6 mo

  4. Patent 9464071 expires

    Listed method-of-use patent (U-3805) expiration.

    Apr 28, 2031

    in 4 yr 10 mo

  5. Patent 8895601 expires

    Listed drug substance patent expiration.

    Apr 12, 2033

    in 6 yr 10 mo

  6. Patent 9902714 expires

    Listed drug product patent expiration.

    Mar 26, 2035

    in 8 yr 10 mo

  7. Patent 12037644 expires

    Listed method-of-use patent (U-3972) expiration.

    Oct 18, 2035

    in 9 yr 4 mo

  8. Patent 10898482 expires

    Listed drug product patent expiration.

    Feb 09, 2036

    in 9 yr 8 mo

  9. Patent 10898482 expires

    Listed drug product patent expiration.

    Feb 09, 2036

    in 9 yr 8 mo

  10. Patent 10898482 expires

    Listed drug product patent expiration.

    Feb 09, 2036

    in 9 yr 8 mo

  11. Patent 10898482 expires

    Listed drug product patent expiration.

    Feb 09, 2036

    in 9 yr 8 mo

  12. Patent 10898482 expires

    Listed drug product patent expiration.

    Feb 09, 2036

    in 9 yr 8 mo

  13. Patent 10898482 expires

    Listed drug product patent expiration.

    Feb 09, 2036

    in 9 yr 8 mo

  14. Patent 10898482 expires

    Listed drug product patent expiration.

    Feb 09, 2036

    in 9 yr 8 mo

  15. Patent 11684620 expires

    Listed method-of-use patent (U-3805) expiration.

    Feb 09, 2036

    in 9 yr 8 mo

  16. Patent 11684620 expires

    Listed method-of-use patent (U-3807) expiration.

    Feb 09, 2036

    in 9 yr 8 mo

  17. Patent 11684620 expires

    Listed method-of-use patent (U-3806) expiration.

    Feb 09, 2036

    in 9 yr 8 mo

  18. Patent 10478494 expires

    Listed method-of-use patent (U-3902) expiration.

    Aug 13, 2036

    in 10 yr 2 mo

  19. Patent 11077106 expires

    Listed method-of-use patent (U-3196) expiration.

    Feb 02, 2038

    in 11 yr 8 mo

  20. Patent 11077106 expires

    Listed method-of-use patent (U-3808) expiration.

    Feb 02, 2038

    in 11 yr 8 mo

Protection horizon

Patent & exclusivity timeline

2026202820302032203420362038TodayExclusivity I-930 — 2027-01-19Exclusivity I-930Patent 9464071 — 2031-04-28Patent 9464071Patent 8895601 — 2033-04-12Patent 8895601Patent 9902714 — 2035-03-26Patent 9902714Patent 12037644 — 2035-10-18Patent 12037644Patent 10898482 — 2036-02-09Patent 10898482Patent 10898482 — 2036-02-09Patent 10898482Patent 10898482 — 2036-02-09Patent 10898482Patent 10898482 — 2036-02-09Patent 10898482Patent 10898482 — 2036-02-09Patent 10898482Patent 10898482 — 2036-02-09Patent 10898482Patent 10898482 — 2036-02-09Patent 10898482Patent 11684620 — 2036-02-09Patent 11684620Patent 11684620 — 2036-02-09Patent 11684620Patent 11684620 — 2036-02-09Patent 11684620Patent 10478494 — 2036-08-13Patent 10478494Patent 11077106 — 2038-02-02Patent 11077106Patent 11077106 — 2038-02-02Patent 11077106
Patent expiryExclusivity endToday
FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

ERDAFITINIB

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 212018

Product number

003

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 212018

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Erdafitinib family
Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (1)

  • I-930New indication exclusivity (3 years)

    Jan 19, 2027

    in 6 mo

Orange Book patent file

Listed patents

Listed patents (17)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9464071Apr 28, 2031in 4 yr 10 mo
U-3805
8895601Apr 12, 2033in 6 yr 10 mo
SubstanceProduct
9902714Mar 26, 2035in 8 yr 10 mo
Product
12037644Oct 18, 2035in 9 yr 4 mo
U-3972
10898482Feb 09, 2036in 9 yr 8 mo
ProductU-3067
10898482Feb 09, 2036in 9 yr 8 mo
ProductU-3066
10898482Feb 09, 2036in 9 yr 8 mo
ProductU-2518
10898482Feb 09, 2036in 9 yr 8 mo
ProductU-3065
10898482Feb 09, 2036in 9 yr 8 mo
ProductU-3807
10898482Feb 09, 2036in 9 yr 8 mo
ProductU-3805
10898482Feb 09, 2036in 9 yr 8 mo
ProductU-3806
11684620Feb 09, 2036in 9 yr 8 mo
U-3805
11684620Feb 09, 2036in 9 yr 8 mo
U-3807
11684620Feb 09, 2036in 9 yr 8 mo
U-3806
10478494Aug 13, 2036in 10 yr 2 mo
U-3902
11077106Feb 02, 2038in 11 yr 8 mo
U-3196
11077106Feb 02, 2038in 11 yr 8 mo
U-3808

Balversa — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Erdafitinib active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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