TROSPIUM CHLORIDE - Generic Drug Details

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

Trospium chloride is the generic ingredient in four branded drugs marketed by Allergan, Actavis Labs Fl Inc, Granules, Padagis Us, Upsher Smith Labs, Utopic Pharms, Apotex, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharms Inc, Invagen Pharms, Macleods Pharms Ltd, and Bristol-myers, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for trospium chloride. Nineteen suppliers are listed for this compound.

Summary for TROSPIUM CHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	13
NDAs:	15
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	21
Patent Applications:	1,337
Drug Prices:	Drug price trends for TROSPIUM CHLORIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TROSPIUM CHLORIDE
What excipients (inactive ingredients) are in TROSPIUM CHLORIDE?	TROSPIUM CHLORIDE excipients list
DailyMed Link:	TROSPIUM CHLORIDE at DailyMed

See drug prices for TROSPIUM CHLORIDE

Recent Clinical Trials for TROSPIUM CHLORIDE

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

Sponsor	Phase
The University of Texas Medical Branch, Galveston	Early Phase 1
Mansoura University	N/A
Amiri Hospital	N/A

See all TROSPIUM CHLORIDE clinical trials

Pharmacology for TROSPIUM CHLORIDE

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for TROSPIUM CHLORIDE

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

Paragraph IV (Patent) Challenges for TROSPIUM CHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SANCTURA XR	Extended-release Capsules	trospium chloride	60 mg	022103	1	2009-03-02

US Patents and Regulatory Information for TROSPIUM CHLORIDE

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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
Macleods Pharms Ltd	TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	206472-001	Jun 18, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	091513-001	Dec 6, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Granules	TROSPIUM CHLORIDE	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	213185-001	Apr 23, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage Pharms Inc	TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	204945-001	Aug 30, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for TROSPIUM CHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	⤷ Sign Up	⤷ Sign Up
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	⤷ Sign Up	⤷ Sign Up
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	⤷ Sign Up	⤷ Sign Up
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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