TROSPIUM CHLORIDE Drug Patent Profile
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When do Trospium Chloride patents expire, and what generic alternatives are available?
Trospium Chloride is a drug marketed by 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 eleven NDAs.
The generic ingredient in TROSPIUM CHLORIDE is trospium chloride. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Trospium Chloride
A generic version of TROSPIUM CHLORIDE was approved as trospium chloride by GLENMARK GENERICS on August 13th, 2010.
Summary 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 |
Pharmacology for TROSPIUM CHLORIDE
Drug Class | Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for TROSPIUM CHLORIDE
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Labs Fl Inc | TROSPIUM CHLORIDE | trospium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 091289-001 | Oct 12, 2012 | AB | RX | No | Yes | ⤷ 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 | |||
Padagis Us | TROSPIUM CHLORIDE | trospium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 201291-001 | May 24, 2013 | AB | RX | No | No | ⤷ 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 | |||
Amta | TROSPIUM CHLORIDE | trospium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 214760-001 | Apr 30, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Granules | TROSPIUM CHLORIDE | trospium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 213185-001 | Apr 23, 2020 | AB | RX | 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 |