Tofersen - Generic Drug Details
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What are the generic drug sources for tofersen and what is the scope of patent protection?
Tofersen
is the generic ingredient in one branded drug marketed by Biogen Ma and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tofersen has fifty-six patent family members in twenty-five countries.
One supplier is listed for this compound.
Summary for tofersen
| International Patents: | 56 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| What excipients (inactive ingredients) are in tofersen? | tofersen excipients list |
| DailyMed Link: | tofersen at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for tofersen
Generic Entry Date for tofersen*:
Constraining patent/regulatory exclusivity:
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE Dosage:
SOLUTION;INTRATHECAL |
*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 tofersen
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Biogen | Phase 3 |
| Ionis Pharmaceuticals, Inc. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for tofersen
US Patents and Regulatory Information for tofersen
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biogen Ma | QALSODY | tofersen | SOLUTION;INTRATHECAL | 215887-001 | Apr 25, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biogen Ma | QALSODY | tofersen | SOLUTION;INTRATHECAL | 215887-001 | Apr 25, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biogen Ma | QALSODY | tofersen | SOLUTION;INTRATHECAL | 215887-001 | Apr 25, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Biogen Ma | QALSODY | tofersen | SOLUTION;INTRATHECAL | 215887-001 | Apr 25, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biogen Ma | QALSODY | tofersen | SOLUTION;INTRATHECAL | 215887-001 | Apr 25, 2023 | 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 |
International Patents for tofersen
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Singapore | 11201608109T | COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION | ⤷ Try a Trial |
| Malaysia | 192634 | COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2015153800 | ⤷ Try a Trial | |
| Denmark | 3126499 | ⤷ Try a Trial | |
| Japan | 2023027299 | ＳＯＤ－１発現を調節するための組成物 | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
