DEXTROMETHORPHAN POLISTIREX - Generic Drug Details
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What are the generic drug sources for dextromethorphan polistirex and what is the scope of freedom to operate?
Dextromethorphan polistirex
is the generic ingredient in two branded drugs marketed by Rb Hlth, Amneal, and Tris Pharma Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for dextromethorphan polistirex. Twenty-eight suppliers are listed for this compound.
Summary for DEXTROMETHORPHAN POLISTIREX
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 28 |
Raw Ingredient (Bulk) Api Vendors: | 37 |
Patent Applications: | 1,952 |
What excipients (inactive ingredients) are in DEXTROMETHORPHAN POLISTIREX? | DEXTROMETHORPHAN POLISTIREX excipients list |
DailyMed Link: | DEXTROMETHORPHAN POLISTIREX at DailyMed |
Pharmacology for DEXTROMETHORPHAN POLISTIREX
Drug Class | Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist |
Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for DEXTROMETHORPHAN POLISTIREX
Anatomical Therapeutic Chemical (ATC) Classes for DEXTROMETHORPHAN POLISTIREX
Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN POLISTIREX
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
DELSYM | Extended-release Suspension | dextromethorphan polistirex | 30 mg/5 mL | 018658 | 1 | 2009-01-12 |
US Patents and Regulatory Information for DEXTROMETHORPHAN POLISTIREX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amneal | DEXTROMETHORPHAN POLISTIREX | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 203133-001 | Jul 28, 2017 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Tris Pharma Inc | DEXTROMETHORPHAN POLISTIREX | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 091135-001 | May 25, 2012 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Rb Hlth | DELSYM | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 018658-001 | Oct 8, 1982 | OTC | Yes | Yes | ⤷ 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 DEXTROMETHORPHAN POLISTIREX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Rb Hlth | DELSYM | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 018658-001 | Oct 8, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Rb Hlth | DELSYM | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 018658-001 | Oct 8, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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