SEVELAMER CARBONATE Drug Patent Profile
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When do Sevelamer Carbonate patents expire, and when can generic versions of Sevelamer Carbonate launch?
Sevelamer Carbonate is a drug marketed by Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Lupin Ltd, Strides Pharma, Amneal Pharms Co, Anxin, Arthur Grp, Impax Labs Inc, Invagen Pharms, Macleods Pharms Ltd, Micro Labs, Rising, and Zydus Pharms. and is included in twenty NDAs.
The generic ingredient in SEVELAMER CARBONATE is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sevelamer Carbonate
A generic version of SEVELAMER CARBONATE was approved as sevelamer carbonate by AUROBINDO PHARMA on June 13th, 2017.
Summary for SEVELAMER CARBONATE
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 20 |
| Finished Product Suppliers / Packagers: | 25 |
| Raw Ingredient (Bulk) Api Vendors: | 33 |
| Clinical Trials: | 53 |
| Patent Applications: | 296 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SEVELAMER CARBONATE |
| What excipients (inactive ingredients) are in SEVELAMER CARBONATE? | SEVELAMER CARBONATE excipients list |
| DailyMed Link: | SEVELAMER CARBONATE at DailyMed |
Recent Clinical Trials for SEVELAMER CARBONATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alebund Pharmaceuticals | Phase 2 |
| Shanghai Alebund Pharmaceuticals Limited | Phase 2 |
| Akebia Therapeutics | Phase 1 |
Pharmacology for SEVELAMER CARBONATE
| Drug Class | Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for SEVELAMER CARBONATE
Paragraph IV (Patent) Challenges for SEVELAMER CARBONATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| RENVELA | Powder for Oral Suspension | sevelamer carbonate | 0.8 g/packet and 2.4 g/packet | 022318 | 1 | 2009-12-30 |
| RENVELA | Tablets | sevelamer carbonate | 800 mg | 022127 | 1 | 2008-12-04 |
US Patents and Regulatory Information for SEVELAMER CARBONATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 207624-001 | Jun 13, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Chartwell Rx | SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 204600-001 | Jan 14, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Rising | SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 204451-001 | Nov 29, 2018 | 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 |
EU/EMA Drug Approvals for SEVELAMER CARBONATE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Sanofi B.V. | Renvela | sevelamer carbonate | EMEA/H/C/000993 Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease. |
Authorised | no | no | no | 2009-06-09 | |
| Sanofi B.V. | Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) | sevelamer carbonate | EMEA/H/C/003971 Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L.Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease. |
Authorised | no | no | no | 2015-01-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
