SEVELAMER CARBONATE - Generic Drug Details
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What are the generic sources for sevelamer carbonate and what is the scope of patent protection?
Sevelamer carbonate
is the generic ingredient in two branded drugs marketed by Genzyme, Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, Strides Pharma, Sanofi, Amneal Pharms Co, Arthur Grp, Impax Labs Inc, Micro Labs, Rising, Sinotherapeutics Inc, and Zydus Pharms, and is included in twenty-five NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Sevelamer carbonate has fifty-four patent family members in twenty-one countries.
There are seventeen drug master file entries for sevelamer carbonate. Twenty-seven suppliers are listed for this compound.
Summary for SEVELAMER CARBONATE
International Patents: | 54 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 18 |
NDAs: | 25 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 27 |
Raw Ingredient (Bulk) Api Vendors: | 33 |
Clinical Trials: | 53 |
Patent Applications: | 609 |
Drug Prices: | Drug price trends 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 201513-002 | Dec 23, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Macleods Pharms Ltd | SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 207291-002 | Apr 25, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Strides Pharma | SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 211915-001 | May 9, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 207179-001 | Jul 17, 2017 | 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 |
Expired US Patents for SEVELAMER CARBONATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for SEVELAMER CARBONATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1807057 | ⤷ Sign Up | |
Hungary | E033638 | ⤷ Sign Up | |
European Patent Office | 3000460 | FORMULATION EN SACHET POUR DES POLYMÈRES AMINES (SACHET FORMULATION FOR AMINE POLYMERS) | ⤷ Sign Up |
South Korea | 101574072 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SEVELAMER CARBONATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0716606 | C300428 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610 |
0716606 | 49/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610 |
0716606 | 02C0011 | France | ⤷ Sign Up | PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128 |
0716606 | SPC/GB02/011 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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