RENAGEL Drug Patent Profile
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When do Renagel patents expire, and what generic alternatives are available?
Renagel is a drug marketed by Genzyme and is included in two NDAs.
The generic ingredient in RENAGEL is sevelamer hydrochloride. There are thirty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Renagel
A generic version of RENAGEL was approved as sevelamer hydrochloride by GLENMARK PHARMS LTD on February 8th, 2019.
Summary for RENAGEL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 19 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RENAGEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RENAGEL |
| What excipients (inactive ingredients) are in RENAGEL? | RENAGEL excipients list |
| DailyMed Link: | RENAGEL at DailyMed |
Recent Clinical Trials for RENAGEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical University of Lodz | Phase 4 |
| Shire | Phase 4 |
| Medical Universtity of Lodz | Phase 4 |
Pharmacology for RENAGEL
| Drug Class | Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for RENAGEL
Paragraph IV (Patent) Challenges for RENAGEL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| RENAGEL | Tablets | sevelamer hydrochloride | 400 mg and 800 mg | 021179 | 1 | 2008-05-22 |
US Patents and Regulatory Information for RENAGEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genzyme | RENAGEL | sevelamer hydrochloride | CAPSULE;ORAL | 020926-001 | Oct 30, 1998 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-001 | Jul 12, 2000 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-002 | Jul 12, 2000 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for RENAGEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-002 | Jul 12, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-002 | Jul 12, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Genzyme | RENAGEL | sevelamer hydrochloride | CAPSULE;ORAL | 020926-001 | Oct 30, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-001 | Jul 12, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-001 | Jul 12, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-002 | Jul 12, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for RENAGEL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Genzyme Europe BV | Tasermity | sevelamer hydrochloride | EMEA/H/C/003968 Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease., |
Withdrawn | no | no | no | 2015-02-25 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for RENAGEL
See the table below for patents covering RENAGEL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2169356 | POLYMERES SE LIANT AUX PHOSPHATES POUR ADMINISTRATION ORALE (PHOSPHATE-BINDING POLYMERS FOR ORAL ADMINISTRATION) | ⤷ Try a Trial |
| Hong Kong | 1036753 | ⤷ Try a Trial | |
| Japan | 3113283 | ⤷ Try a Trial | |
| Japan | 2012067132 | DIRECT COMPRESSION POLYMER TABLET CORE | ⤷ Try a Trial |
| European Patent Office | 0831857 | ⤷ Try a Trial | |
| Denmark | 1133989 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RENAGEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0716606 | C300428 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610 |
| 0716606 | CA 2002 00003 | Denmark | ⤷ Try a Trial | |
| 0716606 | 91629 | Luxembourg | ⤷ Try a Trial | 91629, EXPIRES: 20190810 |
| 0716606 | 49/2009 | Austria | ⤷ Try a Trial | PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610 |
| 0716606 | SPC004/2002 | Ireland | ⤷ Try a Trial | SPC004/2002, 20040614, EXPIRES: 20150127 |
| 0716606 | C300080 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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