Sodium polystyrene sulfonate - Generic Drug Details
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What are the generic drug sources for sodium polystyrene sulfonate and what is the scope of patent protection?
Sodium polystyrene sulfonate
is the generic ingredient in five branded drugs marketed by Kvk Tech, Concordia, Ani Pharms, Belcher, Chartwell Rx, Citrusphrma, Cmp Pharma Inc, Epic Pharma Llc, Nuvo Pharms Inc, Pai Holdings Pharm, Upsher Smith Labs, Hikma, Morton Grove, and Roxane, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for sodium polystyrene sulfonate. Twelve suppliers are listed for this compound.
Summary for sodium polystyrene sulfonate
| US Patents: | 0 |
| Tradenames: | 5 |
| Applicants: | 14 |
| NDAs: | 17 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 56 |
| Clinical Trials: | 7 |
| Drug Prices: | Drug price trends for sodium polystyrene sulfonate |
| What excipients (inactive ingredients) are in sodium polystyrene sulfonate? | sodium polystyrene sulfonate excipients list |
| DailyMed Link: | sodium polystyrene sulfonate at DailyMed |
Recent Clinical Trials for sodium polystyrene sulfonate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Irvine | Phase 4 |
| Tris Pharma, Inc. | Phase 4 |
| Weill Medical College of Cornell University | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for sodium polystyrene sulfonate
US Patents and Regulatory Information for sodium polystyrene sulfonate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nuvo Pharms Inc | SODIUM POLYSTYRENE SULFONATE | sodium polystyrene sulfonate | POWDER;ORAL, RECTAL | 204071-002 | Nov 28, 2014 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Epic Pharma Llc | SODIUM POLYSTYRENE SULFONATE | sodium polystyrene sulfonate | POWDER;ORAL, RECTAL | 202333-001 | Mar 19, 2014 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | SODIUM POLYSTYRENE SULFONATE | sodium polystyrene sulfonate | POWDER;ORAL, RECTAL | 206815-001 | Feb 18, 2016 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cmp Pharma Inc | SODIUM POLYSTYRENE SULFONATE | sodium polystyrene sulfonate | POWDER;ORAL, RECTAL | 089910-001 | Jan 19, 1989 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Kvk Tech | KALEXATE | sodium polystyrene sulfonate | POWDER;ORAL, RECTAL | 040905-001 | Mar 30, 2009 | AA | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cmp Pharma Inc | SPS | sodium polystyrene sulfonate | SUSPENSION;ORAL, RECTAL | 087859-001 | Dec 8, 1982 | AA | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Concordia | KAYEXALATE | sodium polystyrene sulfonate | POWDER;ORAL, RECTAL | 011287-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
