Application 216158

Type: NDA
Sponsor: BRISTOL-MYERS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COBENFY	TROSPIUM CHLORIDE; XANOMELINE TARTRATE	CAPSULE;ORAL	20MG;EQ 50MG BASE	Yes	Yes
002	COBENFY	TROSPIUM CHLORIDE; XANOMELINE TARTRATE	CAPSULE;ORAL	20MG;EQ 100MG BASE	Yes	No
003	COBENFY	TROSPIUM CHLORIDE; XANOMELINE TARTRATE	CAPSULE;ORAL	30MG;EQ 125MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216158-001	COBENFY	TROSPIUM CHLORIDE; XANOMELINE TARTRATE	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26
N216158-002	COBENFY	TROSPIUM CHLORIDE; XANOMELINE TARTRATE	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26
N216158-003	COBENFY	TROSPIUM CHLORIDE; XANOMELINE TARTRATE	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD	2024-09-26

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216158-001	10238643	2030-07-21		Drug product	2024-10-25
N216158-001	10265311	2030-07-21	U-3513		2024-10-25
N216158-001	10369143	2030-07-21	U-3513		2024-10-25
N216158-001	10369144	2030-07-21	U-3513	Drug product	2024-10-25
N216158-001	10695339	2030-07-21	U-3513		2024-10-25
N216158-001	10925832	2039-09-27		Drug product	2024-10-25
N216158-001	10933020	2039-09-27	U-3513	Drug product	2024-10-25
N216158-001	11452692	2039-09-27	U-3513		2024-10-25
N216158-001	11471413	2039-09-27	U-3513		2024-10-25
N216158-001	11890378	2039-09-27	U-3513	Drug product	2024-10-25
N216158-001	12558317	2039-10-29		Drug product	2026-03-24
N216158-002	10238643	2030-07-21		Drug product	2024-10-25
N216158-002	10265311	2030-07-21	U-3513		2024-10-25
N216158-002	10369143	2030-07-21	U-3513		2024-10-25
N216158-002	10369144	2030-07-21	U-3513	Drug product	2024-10-25
N216158-002	10695339	2030-07-21	U-3513		2024-10-25
N216158-002	10925832	2039-09-27		Drug product	2024-10-25
N216158-002	10933020	2039-09-27	U-3513	Drug product	2024-10-25
N216158-002	11452692	2039-09-27	U-3513		2024-10-25
N216158-002	11471413	2039-09-27	U-3513		2024-10-25
N216158-002	11890378	2039-09-27	U-3513	Drug product	2024-10-25
N216158-002	12558317	2039-10-29		Drug product	2026-03-24
N216158-003	10238643	2030-07-21		Drug product	2024-10-25
N216158-003	10265311	2030-07-21	U-3513		2024-10-25
N216158-003	10369143	2030-07-21	U-3513		2024-10-25
N216158-003	10369144	2030-07-21	U-3513	Drug product	2024-10-25
N216158-003	10695339	2030-07-21	U-3513		2024-10-25
N216158-003	10925832	2039-09-27		Drug product	2024-10-25
N216158-003	10933020	2039-09-27	U-3513	Drug product	2024-10-25
N216158-003	11452692	2039-09-27	U-3513		2024-10-25
N216158-003	11471413	2039-09-27	U-3513		2024-10-25
N216158-003	11890378	2039-09-27	U-3513	Drug product	2024-10-25
N216158-003	12558317	2039-10-29		Drug product	2026-03-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216158-001	NCE	2029-09-26
N216158-002	NCE	2029-09-26
N216158-003	NCE	2029-09-26

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 273 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216158-001	10238643	2030-07-21		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10265311	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10369143	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10369144	2030-07-21	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10695339	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10925832	2039-09-27		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10933020	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	11452692	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	11471413	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	11890378	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10238643	2030-07-21		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10265311	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10369143	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10369144	2030-07-21	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10695339	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10925832	2039-09-27		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10933020	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	11452692	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	11471413	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	11890378	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10238643	2030-07-21		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10265311	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10369143	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10369144	2030-07-21	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10695339	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10925832	2039-09-27		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10933020	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	11452692	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	11471413	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	11890378	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10238643	2030-07-21		Drug product	2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10265311	2030-07-21	U-3513		2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10369143	2030-07-21	U-3513		2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10369144	2030-07-21	U-3513	Drug product	2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10695339	2030-07-21	U-3513		2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10925832	2039-09-27		Drug product	2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10933020	2039-09-27	U-3513	Drug product	2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	11452692	2039-09-27	U-3513		2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	11471413	2039-09-27	U-3513		2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	11890378	2039-09-27	U-3513	Drug product	2024-10-25	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216158-001	NCE	2029-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	NCE	2029-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	NCE	2029-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	NCE	2029-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-002	NCE	2029-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-003	NCE	2029-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216158-001	NCE	2029-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216158-002	NCE	2029-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216158-003	NCE	2029-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-001	NCE	2029-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-002	NCE	2029-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-003	NCE	2029-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-001	NCE	2029-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-002	NCE	2029-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-003	NCE	2029-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-001	NCE	2029-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-002	NCE	2029-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-003	NCE	2029-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-001	NCE	2029-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-002	NCE	2029-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-003	NCE	2029-09-26	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-001	NCE	2029-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-002	NCE	2029-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-003	NCE	2029-09-26	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-001	NCE	2029-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-002	NCE	2029-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-003	NCE	2029-09-26	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cobenfy	XANOMELINE AND TROSPIUM CHLORIDE	E.R. Squibb & Sons, L.L.C.	8f0e73bf-6025-44f6-ab64-0983322de0df	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216158 application number: NDA216158

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80168	ORIG	2024-11-05
79755	ORIG	2024-09-27
79752	ORIG	2024-09-27