FDA.reportPublic FDA data

Application 217389

Type
NDA
Sponsor
MSD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OHTUVAYREENSIFENTRINESUSPENSION;INHALATION3MG/2.5MLYesYes

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
N217389-001OHTUVAYREENSIFENTRINE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-26

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217389-00190620472031-08-21U-3962Drug substance2024-07-12
N217389-001109459502035-09-15Drug product2024-07-12
N217389-00199561712035-09-15U-3962Drug product2024-07-12
N217389-001124091802043-02-20Drug product2025-10-07
N217389-001122513842044-06-25Drug product2025-03-26

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217389-001NCE2029-06-26

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 13:18:302026-09N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-26c2088c7a36db…
2026-09-14 22:38:342026-08N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-2684e616aacf4f…
2026-08-18 06:07:402026-07N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-26301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217389-001OHTUVAYRE3MG/2.5MLSUSPENSION / INHALATIONRLD, RS2024-06-26a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N217389-00190620472031-08-21U-3962Drug substance2024-07-12c2088c7a36db…
2026-10-15 13:18:302026-09N217389-001109459502035-09-15Drug product2024-07-12c2088c7a36db…
2026-10-15 13:18:302026-09N217389-00199561712035-09-15U-3962Drug product2024-07-12c2088c7a36db…
2026-10-15 13:18:302026-09N217389-001124091802043-02-20Drug product2025-10-07c2088c7a36db…
2026-10-15 13:18:302026-09N217389-001122513842044-06-25Drug product2025-03-26c2088c7a36db…
2026-09-14 22:38:342026-08N217389-00190620472031-08-21U-3962Drug substance2024-07-1284e616aacf4f…
2026-09-14 22:38:342026-08N217389-001109459502035-09-15Drug product2024-07-1284e616aacf4f…
2026-09-14 22:38:342026-08N217389-00199561712035-09-15U-3962Drug product2024-07-1284e616aacf4f…
2026-09-14 22:38:342026-08N217389-001124091802043-02-20Drug product2025-10-0784e616aacf4f…
2026-09-14 22:38:342026-08N217389-001122513842044-06-25Drug product2025-03-2684e616aacf4f…
2026-08-18 06:07:402026-07N217389-00190620472031-08-21U-3962Drug substance2024-07-12caaa826d4ba7…
2026-08-18 06:07:402026-07N217389-001109459502035-09-15Drug product2024-07-12caaa826d4ba7…
2026-08-18 06:07:402026-07N217389-00199561712035-09-15U-3962Drug product2024-07-12caaa826d4ba7…
2026-08-18 06:07:402026-07N217389-001124091802043-02-20Drug product2025-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217389-001122513842044-06-25Drug product2025-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217389-00190620472031-08-21U-3962Drug substance2024-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217389-001109459502035-09-15Drug product2024-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217389-00199561712035-09-15U-3962Drug product2024-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217389-001124091802043-02-20Drug product2025-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217389-001122513842044-06-25Drug product2025-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217389-00190620472031-08-21U-3962Drug substance2024-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217389-001109459502035-09-15Drug product2024-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217389-00199561712035-09-15U-3962Drug product2024-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217389-001124091802043-02-20Drug product2025-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217389-001122513842044-06-25Drug product2025-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N217389-00190620472031-08-21U-3962Drug substance2024-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217389-001109459502035-09-15Drug product2024-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217389-00199561712035-09-15U-3962Drug product2024-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217389-001122513842044-06-25Drug product2025-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217389-00190620472031-08-21U-3962Drug substance2024-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217389-001109459502035-09-15Drug product2024-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217389-00199561712035-09-15U-3962Drug product2024-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217389-00190620472031-08-21U-3962Drug substance2024-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217389-001109459502035-09-15Drug product2024-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217389-00199561712035-09-15U-3962Drug product2024-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217389-00190620472031-08-21U-3962Drug substance2024-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217389-001109459502035-09-15Drug product2024-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217389-00199561712035-09-15U-3962Drug product2024-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217389-00190620472031-08-21U-3962Drug substance2024-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217389-001109459502035-09-15Drug product2024-07-122680178bc6a6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N217389-001NCE2029-06-26c2088c7a36db…
2026-09-14 22:38:342026-08N217389-001NCE2029-06-2684e616aacf4f…
2026-08-18 06:07:402026-07N217389-001NCE2029-06-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217389-001NCE2029-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217389-001NCE2029-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N217389-001NCE2029-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217389-001NCE2029-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217389-001NCE2029-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217389-001NCE2029-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217389-001NCE2029-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217389-001NCE2029-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217389-001NCE2029-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217389-001NCE2029-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217389-001NCE2029-06-2679d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217389-001NCE2029-06-26a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79127ORIG 2024-07-22
78913ORIG 2024-06-28
78916ORIG 2024-06-27