Sevelamer hydrochloride - Generic Drug Details
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What are the generic sources for sevelamer hydrochloride and what is the scope of patent protection?
Sevelamer hydrochloride
is the generic ingredient in two branded drugs marketed by Genzyme, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, and Rising, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for sevelamer hydrochloride. Eight suppliers are listed for this compound.
Summary for sevelamer hydrochloride
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 6 |
NDAs: | 7 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 50 |
Clinical Trials: | 79 |
Patent Applications: | 484 |
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
Expired US Patents for sevelamer hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-002 | Jul 12, 2000 | ⤷ Subscribe | ⤷ Subscribe |
Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-002 | Jul 12, 2000 | ⤷ Subscribe | ⤷ Subscribe |
Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-001 | Jul 12, 2000 | ⤷ Subscribe | ⤷ Subscribe |
Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-001 | Jul 12, 2000 | ⤷ Subscribe | ⤷ Subscribe |
Genzyme | RENAGEL | sevelamer hydrochloride | CAPSULE;ORAL | 020926-001 | Oct 30, 1998 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
Sevelamer hydrochloride Market Analysis and Financial Projection Experimental
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