XACDURO (COPACKAGED) Drug Patent Profile
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Which patents cover Xacduro (copackaged), and what generic alternatives are available?
Xacduro (copackaged) is a drug marketed by Entasis Therap and is included in one NDA. There are four patents protecting this drug.
This drug has seventy-eight patent family members in forty-two countries.
The generic ingredient in XACDURO (COPACKAGED) is durlobactam sodium; durlobactam sodium; sulbactam sodium. One supplier is listed for this compound. Additional details are available on the durlobactam sodium; durlobactam sodium; sulbactam sodium profile page.
DrugPatentWatch® Generic Entry Outlook for Xacduro (copackaged)
Xacduro (copackaged) will be eligible for patent challenges on May 23, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 23, 2033. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
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Summary for XACDURO (COPACKAGED)
International Patents: | 78 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
DailyMed Link: | XACDURO (COPACKAGED) at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XACDURO (COPACKAGED)
Generic Entry Date for XACDURO (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW NDA:
Dosage:
POWDER;INTRAVENOUS |
*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 XACDURO (COPACKAGED)
XACDURO (COPACKAGED) is protected by four US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XACDURO (COPACKAGED) is ⤷ Sign Up.
This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.
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 XACDURO (COPACKAGED)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)
FDA Regulatory Exclusivity protecting XACDURO (COPACKAGED)
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
GENERATING ANTIBIOTIC INCENTIVES NOW
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Entasis Therap | XACDURO (COPACKAGED) | durlobactam sodium; durlobactam sodium; sulbactam sodium | POWDER;INTRAVENOUS | 216974-001 | May 23, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Entasis Therap | XACDURO (COPACKAGED) | durlobactam sodium; durlobactam sodium; sulbactam sodium | POWDER;INTRAVENOUS | 216974-001 | May 23, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Entasis Therap | XACDURO (COPACKAGED) | durlobactam sodium; durlobactam sodium; sulbactam sodium | POWDER;INTRAVENOUS | 216974-001 | May 23, 2023 | 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 XACDURO (COPACKAGED)
When does loss-of-exclusivity occur for XACDURO (COPACKAGED)?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 0539
Patent: COMPUESTOS INHIBIDORES DE b LACTAMASA
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 13245399
Patent: Heterobicyclic compounds as beta-lactamase inhibitors
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2014024279
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 66467
Patent: COMPOSES HETEROBICYCLIQUES COMME INHIBITEURS DE LA BETA-LACTAMASE (HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 14002589
Patent: Compuestos inhibidores de beta-lactamasas derivados de 7-oxo-1,6-diazabiciclo[3.2.1] octano; composicion farmaceutica que los comprende y uso para tratar una infeccion bacteriana.
Estimated Expiration: ⤷ Sign Up
China
Patent: 4364254
Patent: Heterobicyclic compounds as beta-lactamase inhibitors
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 71137
Patent: Compuetos inhibidores de beta-lactamasas
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 140428
Patent: COMPUESTOS INHIBIDORES DE BETA-LACTAMASAS
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0180450
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 20269
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 34239
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 014000212
Patent: COMPUESTOS INHIBIDORES DE BETA-LACTAMASAS
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 34239
Patent: COMPOSÉS HÉTÉRO-BICYCLIQUES EN TANT QU'INHIBITEURS DE LA BÉTA-LACTAMASE (HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 07071
Patent: 用作β-內酰胺酶抑制劑的雜二環化合物 (HETEROBICYCLIC COMPOUNDS AS BETA LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 36722
Estimated Expiration: ⤷ Sign Up
India
Patent: 82MUN2014
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4660
Patent: תרכובות הטרוביציקליות כמעכבות בטא-לקטמאז (Heterobicyclic compounds as beta-lactamase inhibitors)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 22484
Estimated Expiration: ⤷ Sign Up
Patent: 15512440
Patent: β−ラクタマーゼ阻害剤としてのヘテロ二環式化合物
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 34239
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 6969
Patent: HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 4627
Patent: COMPUESTOS HETEROCICLICOS COMO INHIBIDORES DE BETA-LACTAMASAS. (HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS.)
Estimated Expiration: ⤷ Sign Up
Patent: 14011351
Patent: COMPUESTOS HETEROCICLICOS COMO INHIBIDORES DE BETA-LACTAMASAS. (HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 031
Patent: HETEROCIKLIČNA JEDINJENJA KAO INHIBITORI BETA-LAKTAMAZE (HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 383
Patent: Compose heterobicycliques comme inhibiteurs de la beta lactamase
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0259
Patent: Heterobicyclic compounds as beta-lactamase inhibitors
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 35238
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 142403
Patent: COMPUESTOS INHIBIDORES DE BETA-LACTAMASAS
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 014502224
Patent: HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 34239
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 34239
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 45678
Patent: ПРОИЗВОДНЫЕ 7-ОКСО-1,6-ДИАЗАБИЦИКЛО[3.2.1]ОКТ-3-ЕНА, ПОЛЕЗНЫЕ ДЛЯ ЛЕЧЕНИЯ БАКТЕРИАЛЬНЫХ ИНФЕКЦИЙ (DERIVATIVES OF 7-OXO-1,6-DIAZABICYCLO[3.2.1]OCT-3-ENE, USEFUL FOR BACTERIAL INFECTIONS TREATMENT)
Estimated Expiration: ⤷ Sign Up
Patent: 14141579
Patent: Гетероциклические соединения в качестве ингибиторов бета-лактамаз
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 966
Patent: HETEROBICIKLIČNA JEDINJENJA KAO INHIBITORI BETA-LAKTAMAZE (HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201405965R
Patent: HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 34239
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2042867
Estimated Expiration: ⤷ Sign Up
Patent: 140140625
Patent: HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 63416
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 97281
Estimated Expiration: ⤷ Sign Up
Patent: 1345907
Patent: Beta-lactamase inhibitor compounds
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 14000417
Patent: HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 723
Patent: ?COMPUESTOS DE 7-OXO-1,6-DIAZABICICLO[3.2.1]OCT-3-EN-6-ILO SUSTITUIDOS PARA USARSE COMO INHIBIDORES DE LA BETALACTAMASA?.
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 XACDURO (COPACKAGED) around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Singapore | 11201405965R | HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS | ⤷ Sign Up |
Taiwan | I597281 | ⤷ Sign Up | |
Philippines | 12014502224 | HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |