Vutrisiran - Generic Drug Details
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Summary for vutrisiran
| International Patents: | 202 |
| US Patents: | 12 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for vutrisiran |
| What excipients (inactive ingredients) are in vutrisiran? | vutrisiran excipients list |
| DailyMed Link: | vutrisiran at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for vutrisiran
Generic Entry Date for vutrisiran*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS Dosage:
SOLUTION;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for vutrisiran
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alnylam Pharmaceuticals | PHASE3 |
| Alnylam Pharmaceuticals | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for vutrisiran
US Patents and Regulatory Information for vutrisiran
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | 10,570,391 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | 11,286,486 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | 8,106,022 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | 9,399,775 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | 10,612,024 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | 10,806,791 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
