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Cobenfy

xanomeline and trospium chloride · Capsule, Coated Pellets

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Cobenfy
Generic name
xanomeline and trospium chloride
Dosage form
Capsule, Coated Pellets
Route
Oral
Marketing category
NDA · NDA
Labeler
E.R. Squibb & Sons, L.L.C.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
5
NDC product codes
3
Packages
9
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Trospium Chloride 20 mg/1 857560 View
Trospium Chloride 30 mg/1 857560 View
Xanomeline 100 mg/1 2694843 —
Xanomeline 125 mg/1 2694843 —
Xanomeline 50 mg/1 2694843 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Coated Pellets
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cholinergic Muscarinic Agonist [EPC] EPC 2 members — no class page
Cholinergic Muscarinic Agonists [MoA] MoA 8 members — no class page
Cholinergic Muscarinic Antagonist [EPC] EPC All 33 members
Cholinergic Muscarinic Antagonists [MoA] MoA All 33 members
Cytochrome P450 3A4 Inhibitors [MoA] MoA All 118 members
P-Glycoprotein Inhibitors [MoA] MoA All 105 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
216158
Application type
NDA · New Drug Application
Approval date
September 26, 2024
Sponsor
BRISTOL-MYERS
Products on application
3
Submissions recorded
1
Products approved under application 216158.
Product Trade name Form Strength Ingredient Status TE Flags
216158-001 COBENFY CAPSULE TROSPIUM CHLORIDE; XANOMELINE TARTRATE Prescription — RLD RS
216158-002 COBENFY CAPSULE TROSPIUM CHLORIDE; XANOMELINE TARTRATE Prescription — RLD
216158-003 COBENFY CAPSULE TROSPIUM CHLORIDE; XANOMELINE TARTRATE Prescription — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
10695339 July 21, 2030 001 No U-3513 October 25, 2024
10369144 July 21, 2030 001 No U-3513 October 25, 2024
10369143 July 21, 2030 001 No U-3513 October 25, 2024
10265311 July 21, 2030 001 No U-3513 October 25, 2024
10238643 July 21, 2030 001 No October 25, 2024
10695339 July 21, 2030 002 No U-3513 October 25, 2024
10369144 July 21, 2030 002 No U-3513 October 25, 2024
10369143 July 21, 2030 002 No U-3513 October 25, 2024
10265311 July 21, 2030 002 No U-3513 October 25, 2024
10238643 July 21, 2030 002 No October 25, 2024
10695339 July 21, 2030 003 No U-3513 October 25, 2024
10369144 July 21, 2030 003 No U-3513 October 25, 2024
10369143 July 21, 2030 003 No U-3513 October 25, 2024
10265311 July 21, 2030 003 No U-3513 October 25, 2024
10238643 July 21, 2030 003 No October 25, 2024
11890378 September 27, 2039 001 No U-3513 October 25, 2024
11471413 September 27, 2039 001 No U-3513 October 25, 2024
11452692 September 27, 2039 001 No U-3513 October 25, 2024
10933020 September 27, 2039 001 No U-3513 October 25, 2024
10925832 September 27, 2039 001 No October 25, 2024
11890378 September 27, 2039 002 No U-3513 October 25, 2024
11471413 September 27, 2039 002 No U-3513 October 25, 2024
11452692 September 27, 2039 002 No U-3513 October 25, 2024
10933020 September 27, 2039 002 No U-3513 October 25, 2024
10925832 September 27, 2039 002 No October 25, 2024
11890378 September 27, 2039 003 No U-3513 October 25, 2024
11471413 September 27, 2039 003 No U-3513 October 25, 2024
11452692 September 27, 2039 003 No U-3513 October 25, 2024
10933020 September 27, 2039 003 No U-3513 October 25, 2024
10925832 September 27, 2039 003 No October 25, 2024
12558317 October 29, 2039 001 No March 24, 2026
12558317 October 29, 2039 002 No March 24, 2026
12558317 October 29, 2039 003 No March 24, 2026
Regulatory exclusivity periods.
Code Expires Product
NCE September 26, 2029 001
NCE September 26, 2029 002
NCE September 26, 2029 003

Approval history

Source: Drugs@FDA
Most recent submissions on application 216158.
Type No. Action Status Date Review
Original application 1 Type 1 - New Molecular Entity Approved September 26, 2024 Standard

Review documents

  • 0 · Original application · November 5, 2024
  • 0 · Original application · September 27, 2024
  • 0 · Original application · September 27, 2024

Adverse event reports

Source: openFDA FAERS
4,362
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: TROSPIUM CHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0003-0050-14 0003-0050 E.R. Squibb & Sons, L.L.C. 14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-0050-14) September 27, 2024
0003-0050-60 0003-0050 E.R. Squibb & Sons, L.L.C. 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-0050-60) September 27, 2024
0003-0050-98 0003-0050 E.R. Squibb & Sons, L.L.C. 10 BLISTER PACK in 1 CARTON (0003-0050-98) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK June 15, 2026
0003-0125-14 0003-0125 E.R. Squibb & Sons, L.L.C. 14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-0125-14) September 27, 2024
0003-0125-60 0003-0125 E.R. Squibb & Sons, L.L.C. 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-0125-60) September 27, 2024
0003-0125-98 0003-0125 E.R. Squibb & Sons, L.L.C. 10 BLISTER PACK in 1 CARTON (0003-0125-98) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK June 15, 2026
0003-1100-14 0003-1100 E.R. Squibb & Sons, L.L.C. 14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-1100-14) September 27, 2024
0003-1100-60 0003-1100 E.R. Squibb & Sons, L.L.C. 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-1100-60) September 27, 2024
0003-1100-98 0003-1100 E.R. Squibb & Sons, L.L.C. 10 BLISTER PACK in 1 CARTON (0003-1100-98) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK June 15, 2026
0003-0050 0003-0050 E.R. Squibb & Sons, L.L.C. — September 27, 2024
0003-0125 0003-0125 E.R. Squibb & Sons, L.L.C. — September 27, 2024
0003-1100 0003-1100 E.R. Squibb & Sons, L.L.C. — September 27, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.