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 1.

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
2026-02-19 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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217389-00199561712035-09-15U-3962Drug product2024-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217389-00190620472031-08-21U-3962Drug substance2024-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217389-001109459502035-09-15Drug product2024-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217389-00199561712035-09-15U-3962Drug product2024-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217389-00190620472031-08-21U-3962Drug substance2024-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217389-001109459502035-09-15Drug product2024-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217389-00199561712035-09-15U-3962Drug product2024-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217389-00190620472031-08-21U-3962Drug substance2024-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N217389-001109459502035-09-15Drug product2024-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N217389-00199561712035-09-15U-3962Drug product2024-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217389-00190620472031-08-21U-3962Drug substance2024-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217389-001109459502035-09-15Drug product2024-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217389-00199561712035-09-15U-3962Drug product2024-07-1279d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217389-00190620472031-08-21U-3962Drug substance2024-07-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217389-001109459502035-09-15Drug product2024-07-12a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
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…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OhtuvayreENSIFENTRINEMERCK SHARP & DOHME LLCe6433c98-41a0-4f99-8f7f-d0e9db6e3f402026-04-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 217389
application number: NDA217389

Documents#

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