Trospium chloride - Generic Drug Details

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

Trospium chloride is the generic ingredient in three branded drugs marketed by Allergan, Actavis Labs Fl Inc, Amta, Granules, Padagis Us, Upsher Smith Labs, Apotex, Glenmark Generics, Heritage Pharms Inc, Invagen Pharms, and Zameer Pharms, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

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

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

Sponsor

Phase

The University of Texas Medical Branch, Galveston

Early Phase 1

Mansoura University

N/A

Amiri Hospital

N/A

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

Tradename

Dosage

Ingredient

Strength

NDA

ANDAs Submitted

Submissiondate

Extended-release Capsules

60 mg

2009-03-02

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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
Apotex	TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	091513-001	Dec 6, 2011	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allergan	SANCTURA	trospium chloride	TABLET;ORAL	021595-001	May 28, 2004		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glenmark Generics	TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	091575-001	Aug 13, 2010	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Heritage Pharms Inc	TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	204945-001	Aug 30, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	TROSPIUM CHLORIDE	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	091635-001	Apr 29, 2015		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	13
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	21
Patent Applications:	2,837
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

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists