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-seven 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
Summary for XACDURO (COPACKAGED)
| International Patents: | 77 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | XACDURO (COPACKAGED) at DailyMed |
-patent-expirations.png "XACDURO (COPACKAGED) drug patent expirations")
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.
Anatomical Therapeutic Chemical (ATC) Classes for XACDURO (COPACKAGED)
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 ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial
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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 13245399
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2014024279
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 66467
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 14002589
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4364254
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 71137
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 140428
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0180450
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 20269
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 34239
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 014000212
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 34239
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 07071
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 36722
Estimated Expiration: ⤷ Try a Trial
India
Patent: 82MUN2014
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 4660
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 22484
Estimated Expiration: ⤷ Try a Trial
Patent: 15512440
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 34239
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 6969
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 4627
Estimated Expiration: ⤷ Try a Trial
Patent: 14011351
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 031
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 383
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0259
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 35238
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 142403
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 014502224
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 34239
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 34239
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 45678
Estimated Expiration: ⤷ Try a Trial
Patent: 14141579
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 966
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201405965R
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 34239
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2042867
Estimated Expiration: ⤷ Try a Trial
Patent: 140140625
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 63416
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 97281
Estimated Expiration: ⤷ Try a Trial
Patent: 1345907
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 14000417
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 723
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Turkey | 201905233 | ⤷ Try a Trial | |
| Hungary | E036722 | ⤷ Try a Trial | |
| Brazil | 112017010132 | terapia combinada para tratamento de infecções bacterianas resistentes | ⤷ Try a Trial |
| Argentina | 090539 | COMPUESTOS INHIBIDORES DE b LACTAMASA | ⤷ Try a Trial |
| Taiwan | I597281 | ⤷ Try a Trial | |
| Japan | 6764862 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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