Brincidofovir - Generic Drug Details
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What are the generic drug sources for brincidofovir and what is the scope of freedom to operate?
Brincidofovir
is the generic ingredient in one branded drug marketed by Emergent Biodefense and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Brincidofovir has forty-seven patent family members in fifteen countries.
Two suppliers are listed for this compound.
Summary for brincidofovir
| International Patents: | 47 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 32 |
| Clinical Trials: | 19 |
| Patent Applications: | 436 |
| What excipients (inactive ingredients) are in brincidofovir? | brincidofovir excipients list |
| DailyMed Link: | brincidofovir at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for brincidofovir
Generic Entry Dates for brincidofovir*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION;ORAL |
Generic Entry Dates for brincidofovir*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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 brincidofovir
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| SymBio Pharmaceuticals | Phase 2 |
| SymBio Pharmaceuticals | Phase 1 |
| Food and Drug Administration (FDA) | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for brincidofovir
US Patents and Regulatory Information for brincidofovir
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Emergent Biodefense | TEMBEXA | brincidofovir | TABLET;ORAL | 214461-001 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Emergent Biodefense | TEMBEXA | brincidofovir | SUSPENSION;ORAL | 214460-001 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Emergent Biodefense | TEMBEXA | brincidofovir | TABLET;ORAL | 214461-001 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Emergent Biodefense | TEMBEXA | brincidofovir | TABLET;ORAL | 214461-001 | Jun 4, 2021 | 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 brincidofovir
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2929593 | FORMES MORPHIQUES D'ESTERS D'HEXADECYLOXYPROPYL-PHOSPHONATE (MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS) | ⤷ Try a Trial |
| Russian Federation | 2581045 | ПРОИЗВОДНЫЕ ЭФИРОВ ФОСФОНОВЫХ КИСЛОТ И СПОСОБЫ ИХ СИНТЕЗА (PHOSPHONIC ACID ESTERS AND METHODS FOR SYNTHESIS THEREOF) | ⤷ Try a Trial |
| Japan | 6150949 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2015073148 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
