BAFIERTAM Drug Patent Profile
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When do Bafiertam patents expire, and when can generic versions of Bafiertam launch?
Bafiertam is a drug marketed by Banner Life Sciences and is included in one NDA. There are twenty-one patents protecting this drug.
This drug has twenty 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.
DrugPatentWatch® Generic Entry Outlook for Bafiertam
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 10, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for BAFIERTAM?
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Summary for BAFIERTAM
| International Patents: | 20 |
| US Patents: | 21 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 102 |
| Clinical Trials: | 3 |
| Patent Applications: | 1,194 |
| Drug Prices: | Drug price information for BAFIERTAM |
| What excipients (inactive ingredients) are in BAFIERTAM? | BAFIERTAM excipients list |
| DailyMed Link: | BAFIERTAM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BAFIERTAM
*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
BAFIERTAM is protected by twenty-one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BAFIERTAM is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting BAFIERTAM
Fumarate esters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Fumarate ester dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Fumarate ester pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Fumarate ester pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Fumarate ester pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Fumarate ester pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Controlled release fumarate esters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Controlled release fumarate esters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Fumarate ester pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Fumarate ester pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Fumarate ester dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Fumarate ester dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Fumarate ester dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Fumarate ester pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Fumarate ester dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Fumarate ester dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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
When does loss-of-exclusivity occur for BAFIERTAM?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 15222880
Patent: Controlled release enteric soft capsules of fumarate esters
Estimated Expiration: ⤷ Sign Up
Patent: 15328676
Patent: Controlled release enteric soft capsules of fumarate esters
Estimated Expiration: ⤷ Sign Up
Patent: 16253548
Patent: Controlled release enteric soft capsules of fumarate esters
Estimated Expiration: ⤷ Sign Up
Patent: 17204505
Patent: Controlled release enteric soft capsules of fumarate esters
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 39990
Patent: CAPSULES MOLLES ENTERIQUES A LIBERATION CONTROLEE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS)
Estimated Expiration: ⤷ Sign Up
Patent: 62916
Patent: CAPSULES MOLLES ENTERIQUES A LIBERATION CONTROLEE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS)
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 10408
Estimated Expiration: ⤷ Sign Up
Patent: 01510
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 10408
Patent: CAPSULES MOLLES ENTÉRIQUES À LIBÉRATION CONTRÔLÉE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS)
Estimated Expiration: ⤷ Sign Up
Patent: 01510
Patent: CAPSULES ENTÉRIQUES MOLLES À LIBÉRATION CONTRÔLÉE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS)
Estimated Expiration: ⤷ Sign Up
Patent: 66487
Patent: CAPSULES ENTÉRIQUES MOLLES À LIBÉRATION CONTRÔLÉE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7326
Patent: קפסולות רכות למעיים של פומאראט אסטרים עם שחרור מבוקר (Controlled release enteric soft capsules of fumarate esters)
Estimated Expiration: ⤷ Sign Up
Patent: 5752
Patent: קפסולות רכות למעיים של פומאראט אסטרים עם שחרור מבוקר (Controlled release enteric soft capsules of fumarate esters)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 13157
Estimated Expiration: ⤷ Sign Up
Patent: 17584
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering BAFIERTAM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2939990 | CAPSULES MOLLES ENTERIQUES A LIBERATION CONTROLEE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS) | ⤷ Sign Up |
| European Patent Office | 3766487 | CAPSULES ENTÉRIQUES MOLLES À LIBÉRATION CONTRÔLÉE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS) | ⤷ Sign Up |
| Australia | 2016253548 | Controlled release enteric soft capsules of fumarate esters | ⤷ Sign Up |
| Israel | 275752 | קפסולות רכות למעיים של פומאראט אסטרים עם שחרור מבוקר (Controlled release enteric soft capsules of fumarate esters) | ⤷ Sign Up |
| Australia | 2015222880 | Controlled release enteric soft capsules of fumarate esters | ⤷ Sign Up |
| Canada | 2962916 | CAPSULES MOLLES ENTERIQUES A LIBERATION CONTROLEE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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