FDA.reportPublic FDA data

Application 219285

Type
NDA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EVRYSDIRISDIPLAMTABLET;ORAL5MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219285-001EVRYSDIRISDIPLAM5MGTABLET / ORALRLD, RS2025-02-11

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219285-00195869552033-02-08Drug substance, Drug product2025-03-05
N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-05
N219285-001118276462036-01-25U-19432025-03-05
N219285-001123502732038-10-01U-19432025-07-31
N219285-001115344442038-10-04U-19432025-03-05
N219285-001121227892041-04-15Drug substance, Drug product2025-03-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219285-001M-2702026-10-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-11c2088c7a36db…
2026-09-14 22:38:342026-08N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-1184e616aacf4f…
2026-08-18 06:07:402026-07N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-11fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-11a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N219285-00195869552033-02-08Drug substance, Drug product2025-03-05c2088c7a36db…
2026-10-15 13:18:302026-09N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-05c2088c7a36db…
2026-10-15 13:18:302026-09N219285-001118276462036-01-25U-19432025-03-05c2088c7a36db…
2026-10-15 13:18:302026-09N219285-001123502732038-10-01U-19432025-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N219285-001115344442038-10-04U-19432025-03-05c2088c7a36db…
2026-10-15 13:18:302026-09N219285-001121227892041-04-15Drug substance, Drug product2025-03-05c2088c7a36db…
2026-09-14 22:38:342026-08N219285-00195869552033-02-08Drug substance, Drug product2025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219285-001118276462036-01-25U-19432025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219285-001123502732038-10-01U-19432025-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N219285-001115344442038-10-04U-19432025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219285-001121227892041-04-15Drug substance, Drug product2025-03-0584e616aacf4f…
2026-08-18 06:07:402026-07N219285-00195869552033-02-08Drug substance, Drug product2025-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07N219285-001118276462036-01-25U-19432025-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07N219285-001123502732038-10-01U-19432025-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N219285-001115344442038-10-04U-19432025-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07N219285-001121227892041-04-15Drug substance, Drug product2025-03-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219285-00195869552033-02-08Drug substance, Drug product2025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219285-001118276462036-01-25U-19432025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219285-001123502732038-10-01U-19432025-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219285-001115344442038-10-04U-19432025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219285-001121227892041-04-15Drug substance, Drug product2025-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-00195869552033-02-08Drug substance, Drug product2025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001118276462036-01-25U-19432025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001123502732038-10-01U-19432025-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001115344442038-10-04U-19432025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001121227892041-04-15Drug substance, Drug product2025-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N219285-00195869552033-02-08Drug substance, Drug product2025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-001118276462036-01-25U-19432025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-001123502732038-10-01U-19432025-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-001115344442038-10-04U-19432025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-001121227892041-04-15Drug substance, Drug product2025-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-00195869552033-02-08Drug substance, Drug product2025-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-001118276462036-01-25U-19432025-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-001115344442038-10-04U-19432025-03-05fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N219285-001M-2702026-10-03c2088c7a36db…
2026-09-14 22:38:342026-08N219285-001M-2702026-10-0384e616aacf4f…
2026-08-18 06:07:402026-07N219285-001M-2702026-10-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219285-001M-2702026-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001NCE2025-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001M-2702026-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N219285-001NCE2025-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-001M-2702026-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-001NCE2025-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-001M-2702026-10-03fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219285-001M-2702026-10-03a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85092SUPPL 2026-02-20
85091SUPPL 2026-02-20
84826SUPPL 2026-01-22
84820SUPPL 2026-01-22
83388ORIG 2025-09-19
81249ORIG 2025-02-14
81233ORIG 2025-02-12