TEMBEXA Drug Patent Profile
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When do Tembexa patents expire, and when can generic versions of Tembexa launch?
Tembexa is a drug marketed by Emergent Biodefense and is included in two NDAs. There are five patents protecting this drug.
This drug has forty-seven patent family members in fifteen countries.
The generic ingredient in TEMBEXA is brincidofovir. Two suppliers are listed for this compound. Additional details are available on the brincidofovir profile page.
DrugPatentWatch® Generic Entry Outlook for Tembexa
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 31, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for TEMBEXA?
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Summary for TEMBEXA
| International Patents: | 47 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 32 |
| Patent Applications: | 206 |
| What excipients (inactive ingredients) are in TEMBEXA? | TEMBEXA excipients list |
| DailyMed Link: | TEMBEXA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TEMBEXA
*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.
US Patents and Regulatory Information for TEMBEXA
TEMBEXA is protected by five US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEMBEXA 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 TEMBEXA
Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING HUMAN SMALLPOX DISEASE
Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING HUMAN SMALLPOX DISEASE
Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Phosphonate ester derivatives and methods of synthesis thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING HUMAN SMALLPOX DISEASE
Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting TEMBEXA
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULT AND PEDIATRIC PATIENTS, INCLUDING NEONATES
Exclusivity Expiration: ⤷ Sign Up
| 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 | SUSPENSION;ORAL | 214460-001 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Emergent Biodefense | TEMBEXA | brincidofovir | TABLET;ORAL | 214461-001 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Emergent Biodefense | TEMBEXA | brincidofovir | TABLET;ORAL | 214461-001 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Emergent Biodefense | TEMBEXA | brincidofovir | TABLET;ORAL | 214461-001 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Emergent Biodefense | TEMBEXA | brincidofovir | SUSPENSION;ORAL | 214460-001 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Emergent Biodefense | TEMBEXA | brincidofovir | SUSPENSION;ORAL | 214460-001 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Emergent Biodefense | TEMBEXA | brincidofovir | TABLET;ORAL | 214461-001 | Jun 4, 2021 | 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 TEMBEXA
When does loss-of-exclusivity occur for TEMBEXA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 11295937
Patent: Phosphonate ester derivatives and methods of synthesis thereof
Estimated Expiration: ⤷ Sign Up
Patent: 14349103
Patent: Morphic forms of hexadecyloxypropyl-phosphonate esters
Estimated Expiration: ⤷ Sign Up
Patent: 17202386
Patent: Morphic Forms Of Hexadecyloxypropyl-Phosphonate Esters
Estimated Expiration: ⤷ Sign Up
Patent: 17203315
Patent: Morphic Forms of Hexadecycloxypropyl-Phosphonate Esters
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013004925
Patent: derivados de éster de fosfonato e métodos de síntese deles.
Estimated Expiration: ⤷ Sign Up
Patent: 2016010862
Patent: FORMAS MÓRFICAS DE ÉSTERES DE HEXADECILOXIPROPILFOSFONATO, SEU MÉTODO DE PREPARO E COMPOSIÇÃO COMPREENDENDO A DITA FORMA MÓRFICA
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 09679
Patent: DERIVES ESTERS PHOSPHONATES ET LEURS PROCEDES DE SYNTHESE (PHOSPHONATE ESTER DERIVATIVES AND METHODS OF SYNTHESIS THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 29593
Patent: FORMES MORPHIQUES D'ESTERS D'HEXADECYLOXYPROPYL-PHOSPHONATE (MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 3209985
Patent: Phosphonate ester derivatives and methods of synthesis thereof
Estimated Expiration: ⤷ Sign Up
Patent: 5218580
Patent: Phosphonate ester derivatives and methods of synthesis thereof
Estimated Expiration: ⤷ Sign Up
Patent: 5899215
Patent: 十六烷氧基丙基膦酸酯的形态 (Morphic forms of hexadecyloxypropyl-phosphonate esters)
Estimated Expiration: ⤷ Sign Up
Patent: 5998039
Patent: 膦酸酯衍生物及其合成方法 (Phosphonate ester derivatives and methods of synthesis thereof)
Estimated Expiration: ⤷ Sign Up
Patent: 1777639
Patent: 十六烷氧基丙基膦酸酯的形态 (Morphic forms of hexadecyloxypropyl-phosphonate esters)
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 99476
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1861
Patent: МОРФОЛОГИЧЕСКИЕ ФОРМЫ ГЕКСАДЕЦИЛОКСИПРОПИЛОВЫХ СЛОЖНЫХ ЭФИРОВ ФОСФОНОВОЙ КИСЛОТЫ И СПОСОБЫ ИХ СИНТЕЗА (MORPHIC FORMS OF PHOSPHONIC ACID HEXADECYLOXYPROPYL ESTERS AND METHODS OF SYNTHESIS THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 1691006
Patent: МОРФОЛОГИЧЕСКИЕ ФОРМЫ ГЕКСАДЕЦИЛОКСИПРОПИЛОВЫХ СЛОЖНЫХ ЭФИРОВ ФОСФОНОВОЙ КИСЛОТЫ И СПОСОБЫ ИХ СИНТЕЗА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 11818
Patent: DÉRIVÉS ESTERS PHOSPHONATES ET LEURS PROCÉDÉS DE SYNTHÈSE (PHOSPHONATE ESTER DERIVATIVES AND METHODS OF SYNTHESIS THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 99476
Patent: FORMES MORPHIQUES D'ESTERS D'HEXADÉCYLOXYPROPYL-PHOSPHONATE (MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS)
Estimated Expiration: ⤷ Sign Up
Patent: 20720
Patent: DÉRIVÉS ESTERS PHOSPHONATES ET LEURS PROCÉDÉS DE SYNTHÈSE (PHOSPHONATE ESTER DERIVATIVES AND METHODS OF SYNTHESIS THEREOF)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4955
Patent: צורות מורפיות של אסטרים של חומצה פוספונית ושיטות לסינתזה שלהם (Morphic forms of phosphonic acid esters and methods of synthesis thereof)
Estimated Expiration: ⤷ Sign Up
Patent: 8217
Patent: נגזרות אסטר פוספונטיות ושיטות של סינתזה שלהן (Phosphonate ester derivatives and methods of synthesis thereof)
Estimated Expiration: ⤷ Sign Up
Patent: 5576
Patent: צורות מורפיות של הקסאדציקלוקסיפרופיל-פוספונאט אסטרים (Morphic forms of hexadecyloxypropyl-phosphonate esters)
Estimated Expiration: ⤷ Sign Up
Patent: 9291
Patent: צורות מורפיות של הקסאדציקלוקסיפרופיל-פוספונאט אסטרים (Morphic forms of hexadecyloxypropyl-phosphonate esters)
Estimated Expiration: ⤷ Sign Up
Patent: 2520
Patent: צורות מורפיות של הקסאדציקלוקסיפרופיל-פוספונאט אסטרים (Morphic forms of hexadecyloxypropyl-phosphonate esters)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 50949
Estimated Expiration: ⤷ Sign Up
Patent: 01820
Estimated Expiration: ⤷ Sign Up
Patent: 13536865
Estimated Expiration: ⤷ Sign Up
Patent: 16094388
Patent: ホスホン酸エステル誘導体およびその合成方法 (PHOSPHONATE ESTER DERIVATIVE AND METHOD OF SYNTHESIS THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 16538326
Patent: ヘキサデシルオキシプロピル−ホスホン酸エステルの形態型
Estimated Expiration: ⤷ Sign Up
Patent: 17200919
Patent: ヘキサデシルオキシプロピル−ホスホン酸エステルの形態型 (MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS)
Estimated Expiration: ⤷ Sign Up
Patent: 17200920
Patent: ヘキサデシルオキシプロピル−ホスホン酸エステルの形態型 (MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS)
Estimated Expiration: ⤷ Sign Up
Patent: 17214378
Patent: ホスホン酸エステル誘導体およびその合成方法 (PHOSPHONATE ESTER DERIVATIVES AND METHODS OF SYNTHESIS THEREOF)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 2752
Patent: FORMAS MÓRFICAS DE ÉSTERES DE HEXADECILOXIPROPIL-FOSFONATO. (MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS.)
Estimated Expiration: ⤷ Sign Up
Patent: 16006241
Patent: FORMAS MORFICAS DE ESTERES DE HEXADECILOXIPROPIL-FOSFONATO. (MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS.)
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 81045
Patent: ПРОИЗВОДНЫЕ ЭФИРОВ ФОСФОНОВЫХ КИСЛОТ И СПОСОБЫ ИХ СИНТЕЗА (PHOSPHONIC ACID ESTERS AND METHODS FOR SYNTHESIS THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 13114370
Patent: ПРОИЗВОДНЫЕ ЭФИРОВ ФОСФОНОВЫХ КИСЛОТ И СПОСОБЫ ИХ СИНТЕЗА
Estimated Expiration: ⤷ Sign Up
Patent: 15141024
Patent: ПРОИЗВОДНЫЕ ЭФИРОВ ФОСФОНОВЫХ КИСЛОТ И СПОСОБЫ ИХ СИНТЕЗА
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1812433
Estimated Expiration: ⤷ Sign Up
Patent: 160078500
Patent: 헥사데실옥시프로필-포스포네이트 에스테르의 형체 형태 (MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS)
Estimated Expiration: ⤷ Sign Up
Patent: 170143009
Patent: 헥사데실옥시프로필-포스포네이트 에스테르의 형체 형태 (- MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS)
Estimated Expiration: ⤷ Sign Up
Patent: 170143010
Patent: 헥사데실옥시프로필-포스포네이트 에스테르의 형체 형태 (- MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 04137
Estimated Expiration: ⤷ Sign Up
Patent: 85819
Estimated Expiration: ⤷ Sign Up
Patent: 00117
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 6825
Patent: МОРФОЛОГІЧНІ ФОРМИ ГЕКСАДЕЦИЛОКСИПРОПІЛОВИХ СКЛАДНИХ ЕФІРІВ ФОСФОНОВОЇ КИСЛОТИ І СПОСОБИ ЇХ СИНТЕЗУ (MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS)
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 TEMBEXA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2809679 | DERIVES ESTERS PHOSPHONATES ET LEURS PROCEDES DE SYNTHESE (PHOSPHONATE ESTER DERIVATIVES AND METHODS OF SYNTHESIS THEREOF) | ⤷ Sign Up |
| Russian Federation | 2015141024 | ПРОИЗВОДНЫЕ ЭФИРОВ ФОСФОНОВЫХ КИСЛОТ И СПОСОБЫ ИХ СИНТЕЗА | ⤷ Sign Up |
| China | 105899215 | 十六烷氧基丙基膦酸酯的形态 (Morphic forms of hexadecyloxypropyl-phosphonate esters) | ⤷ Sign Up |
| European Patent Office | 2611818 | DÉRIVÉS ESTERS PHOSPHONATES ET LEURS PROCÉDÉS DE SYNTHÈSE (PHOSPHONATE ESTER DERIVATIVES AND METHODS OF SYNTHESIS THEREOF) | ⤷ Sign Up |
| China | 105998039 | 膦酸酯衍生物及其合成方法 (Phosphonate ester derivatives and methods of synthesis thereof) | ⤷ Sign Up |
| Australia | 2014349103 | Morphic forms of hexadecyloxypropyl-phosphonate esters | ⤷ Sign Up |
| Israel | 238217 | נגזרות אסטר פוספונטיות ושיטות של סינתזה שלהן (Phosphonate ester derivatives and methods of synthesis thereof) | ⤷ 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.
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