COBENFY Drug Patent Profile

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When do Cobenfy patents expire, and when can generic versions of Cobenfy launch?

Cobenfy is a drug marketed by Bristol-myers and is included in one NDA. There are ten patents protecting this drug.

This drug has forty-seven patent family members in twenty-three countries.

The generic ingredient in COBENFY is trospium chloride; xanomeline tartrate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trospium chloride; xanomeline tartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Cobenfy

Cobenfy will be eligible for patent challenges on September 26, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 26, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for COBENFY

International Patents:	47
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	1,371
What excipients (inactive ingredients) are in COBENFY?	COBENFY excipients list
DailyMed Link:	COBENFY at DailyMed

Drug patent expirations by year for COBENFY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COBENFY

Generic Entry Date for COBENFY^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 216158 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.

Pharmacology for COBENFY

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

US Patents and Regulatory Information for COBENFY

COBENFY is protected by ten US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of COBENFY is ⤷ Subscribe.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting COBENFY

Patent Number: 10,238,643
Patent Expiration: ⤷ Subscribe

Patent Number: 10,265,311
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS

Patent Number: 10,369,143
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS

Patent Number: 10,369,144
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS

Patent Number: 10,695,339
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS

Patent Number: 10,925,832
Patent Expiration: ⤷ Subscribe

Patent Number: 10,933,020
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS

Patent Number: 11,452,692
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS

Patent Number: 11,471,413
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS

Patent Number: 11,890,378
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS

FDA Regulatory Exclusivity protecting COBENFY

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Subscribe

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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	216158-003	Sep 26, 2024		RX	Yes	Yes	10,925,832	⤷ Subscribe	Y			⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	Yes	10,369,144	⤷ Subscribe	Y			⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	Yes	10,369,143	⤷ Subscribe				⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-001	Sep 26, 2024		RX	Yes	No	11,890,378	⤷ Subscribe	Y			⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-002	Sep 26, 2024		RX	Yes	No	10,369,143	⤷ Subscribe				⤷ Subscribe
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	Yes	11,471,413	⤷ 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 COBENFY

See the table below for patents covering COBENFY around the world.

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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