ELIGLUSTAT TARTRATE Drug Patent Profile
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Which patents cover Eliglustat Tartrate, and what generic alternatives are available?
Eliglustat Tartrate is a drug marketed by Aizant, Apotex, Dr Reddys, Teva Pharms Usa Inc, and Upsher Smith Labs. and is included in five NDAs.
The generic ingredient in ELIGLUSTAT TARTRATE is eliglustat tartrate. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eliglustat tartrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Eliglustat Tartrate
A generic version of ELIGLUSTAT TARTRATE was approved as eliglustat tartrate by AIZANT on September 8th, 2021.
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Questions you can ask:
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Summary for ELIGLUSTAT TARTRATE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 44 |
| Clinical Trials: | 6 |
| Patent Applications: | 56 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ELIGLUSTAT TARTRATE |
| DailyMed Link: | ELIGLUSTAT TARTRATE at DailyMed |
Recent Clinical Trials for ELIGLUSTAT TARTRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sanofi | Phase 1 |
| Genzyme, a Sanofi Company | Phase 1 |
| Genzyme, a Sanofi Company | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for ELIGLUSTAT TARTRATE
Paragraph IV (Patent) Challenges for ELIGLUSTAT TARTRATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CERDELGA | Capsules | eliglustat tartrate | 84 mg | 205494 | 6 | 2018-08-20 |
US Patents and Regulatory Information for ELIGLUSTAT TARTRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aizant | ELIGLUSTAT TARTRATE | eliglustat tartrate | CAPSULE;ORAL | 212463-001 | Sep 8, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa Inc | ELIGLUSTAT TARTRATE | eliglustat tartrate | CAPSULE;ORAL | 212474-001 | Dec 27, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | ELIGLUSTAT TARTRATE | eliglustat tartrate | CAPSULE;ORAL | 212425-001 | Jul 10, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | ELIGLUSTAT TARTRATE | eliglustat tartrate | CAPSULE;ORAL | 212449-001 | Aug 17, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Upsher Smith Labs | ELIGLUSTAT TARTRATE | eliglustat tartrate | CAPSULE;ORAL | 212420-001 | May 2, 2023 | 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 |
