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BAFIERTAM Drug Profile
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When do Bafiertam patents expire, and what generic alternatives are available?
Bafiertam is a drug marketed by Banner Life Sciences and is included in one NDA. There are fifteen patents protecting this drug.
This drug has nineteen patent family members in seven countries.
The generic ingredient in BAFIERTAM is monomethyl fumarate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the monomethyl fumarate profile page.
US ANDA Litigation and Generic Entry Outlook for Bafiertam
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 27, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for BAFIERTAM
| International Patents: | 19 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Drug Prices: | Drug price information for BAFIERTAM |
| What excipients (inactive ingredients) are in BAFIERTAM? | BAFIERTAM excipients list |
| DailyMed Link: | BAFIERTAM at DailyMed |
Generic Entry Opportunity Date for BAFIERTAM
Generic Entry Date for BAFIERTAM*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, DELAYED RELEASE;ORAL |
*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 BAFIERTAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Banner Life Sciences LLC | Phase 1 |
US Patents and Regulatory Information for BAFIERTAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | Start Trial | 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 |
International Patents for BAFIERTAM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2016057133 | Start Trial |
| Australia | 2017204505 | Start Trial |
| Australia | 2015222880 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2017040272 | Start Trial |
| Australia | 2016253548 | Start Trial |
| Israel | 251402 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
