DEXTROMETHORPHAN POLISTIREX Drug Patent Profile
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Which patents cover Dextromethorphan Polistirex, and what generic alternatives are available?
Dextromethorphan Polistirex is a drug marketed by Amneal and Tris Pharma Inc and is included in two NDAs.
The generic ingredient in DEXTROMETHORPHAN POLISTIREX is dextromethorphan polistirex. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the dextromethorphan polistirex profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dextromethorphan Polistirex
A generic version of DEXTROMETHORPHAN POLISTIREX was approved as dextromethorphan polistirex by TRIS PHARMA INC on May 25th, 2012.
Summary for DEXTROMETHORPHAN POLISTIREX
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Patent Applications: | 1,267 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | DEXTROMETHORPHAN POLISTIREX at DailyMed |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Tris Pharma Inc | DEXTROMETHORPHAN POLISTIREX | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 091135-001 | May 25, 2012 | OTC | 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 |
