Trospium chloride - Generic Drug Details
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What are the generic sources for trospium chloride and what is the scope of patent protection?
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 Pharms Ltd, 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.
Summary for trospium chloride
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: | 1,391 |
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 |
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 |
Amiri Hospital | N/A |
Mansoura University | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Padagis Us | TROSPIUM CHLORIDE | trospium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 201291-001 | May 24, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Actavis Labs Fl Inc | TROSPIUM CHLORIDE | trospium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 091289-001 | Oct 12, 2012 | AB | RX | No | Yes | ⤷ 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 | |||
Amta | TROSPIUM CHLORIDE | trospium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 214760-001 | Apr 30, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Allergan | SANCTURA | trospium chloride | TABLET;ORAL | 021595-001 | May 28, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Zameer Pharms | TROSPIUM CHLORIDE | trospium chloride | TABLET;ORAL | 215781-001 | Feb 16, 2022 | 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 |
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