SEVELAMER HYDROCHLORIDE Drug Patent Profile
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When do Sevelamer Hydrochloride patents expire, and what generic alternatives are available?
Sevelamer Hydrochloride is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, and Rising. and is included in five NDAs.
The generic ingredient in SEVELAMER HYDROCHLORIDE 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 Sevelamer Hydrochloride
A generic version of SEVELAMER HYDROCHLORIDE was approved as sevelamer hydrochloride by GLENMARK PHARMS LTD on February 8th, 2019.
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Questions you can ask:
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Summary for SEVELAMER HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 50 |
| Clinical Trials: | 79 |
| Patent Applications: | 193 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SEVELAMER HYDROCHLORIDE |
| What excipients (inactive ingredients) are in SEVELAMER HYDROCHLORIDE? | SEVELAMER HYDROCHLORIDE excipients list |
| DailyMed Link: | SEVELAMER HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for SEVELAMER HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alebund Pharmaceuticals | Phase 2 |
| Assaf-Harofeh Medical Center | Phase 2 |
| Shanghai Alebund Pharmaceuticals Limited | Phase 2 |
Pharmacology for SEVELAMER HYDROCHLORIDE
| Drug Class | Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for SEVELAMER HYDROCHLORIDE
Paragraph IV (Patent) Challenges for SEVELAMER HYDROCHLORIDE
| 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 SEVELAMER HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | SEVELAMER HYDROCHLORIDE | sevelamer hydrochloride | TABLET;ORAL | 212599-001 | Jul 11, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | SEVELAMER HYDROCHLORIDE | sevelamer hydrochloride | TABLET;ORAL | 206883-001 | May 26, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Pharms Ltd | SEVELAMER HYDROCHLORIDE | sevelamer hydrochloride | TABLET;ORAL | 204724-002 | Feb 8, 2019 | 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 |
EU/EMA Drug Approvals for SEVELAMER HYDROCHLORIDE
| 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 |
