TROSPIUM CHLORIDE; XANOMELINE TARTRATE - Generic Drug Details

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What are the generic sources for trospium chloride; xanomeline tartrate and what is the scope of freedom to operate?

Trospium chloride; xanomeline tartrate is the generic ingredient in one branded drug marketed by Bristol-myers and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trospium chloride; xanomeline tartrate has forty-seven patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for TROSPIUM CHLORIDE; XANOMELINE TARTRATE

International Patents:	47
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	TROSPIUM CHLORIDE; XANOMELINE TARTRATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TROSPIUM CHLORIDE; XANOMELINE TARTRATE

Generic Entry Date for TROSPIUM CHLORIDE; XANOMELINE TARTRATE^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY Dosage: CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TROSPIUM CHLORIDE; XANOMELINE TARTRATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Karuna Therapeutics	Phase 1
Karuna Pharmaceuticals	Phase 1

See all TROSPIUM CHLORIDE; XANOMELINE TARTRATE clinical trials

Pharmacology for TROSPIUM CHLORIDE; XANOMELINE TARTRATE

Drug Class	Cholinergic Muscarinic Agonist Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Agonists Cholinergic Muscarinic Antagonists Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TROSPIUM CHLORIDE; XANOMELINE TARTRATE

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for TROSPIUM CHLORIDE; XANOMELINE TARTRATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-001	Sep 26, 2024		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-001	Sep 26, 2024		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-001	Sep 26, 2024		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-001	Sep 26, 2024		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-001	Sep 26, 2024		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-001	Sep 26, 2024		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for TROSPIUM CHLORIDE; XANOMELINE TARTRATE

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Country	Patent Number	Title	Estimated Expiration
Japan	2021530572		⤷ Subscribe
European Patent Office	3646870	PROCÉDÉS ET COMPOSITIONS POUR LE TRAITEMENT DE TROUBLES AMÉLIORÉS PAR L'ACTIVATION DU RÉCEPTEUR MUSCARINIQUE (METHODS AND COMPOSITIONS FOR TREATMENT OF DISORDERS AMELIORATED BY MUSCARINIC RECEPTOR ACTIVATION)	⤷ Subscribe
Spain	2742728		⤷ Subscribe
European Patent Office	3061821	COMPOSITIONS POUR LE TRAITEMENT DE TROUBLES AMÉLIORÉS PAR L'ACTIVATION DU RÉCEPTEUR MUSCARINIQUE (COMPOSITIONS FOR TREATMENT OF DISORDERS AMELIORATED BY MUSCARINIC RECEPTOR ACTIVATION)	⤷ Subscribe
Hungary	E044653		⤷ Subscribe
China	112789042		⤷ Subscribe
Israel	295341		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.