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Last Updated: March 18, 2024

FARXIGA Drug Patent Profile


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When do Farxiga patents expire, and when can generic versions of Farxiga launch?

Farxiga is a drug marketed by Astrazeneca Ab and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and twenty-seven patent family members in fifty-one countries.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.

DrugPatentWatch® Generic Entry Outlook for Farxiga

Farxiga was eligible for patent challenges on January 8, 2018.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are twelve tentative approvals for the generic drug (dapagliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for FARXIGA
Drug Prices for FARXIGA

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Drug Sales Revenue Trends for FARXIGA

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Recent Clinical Trials for FARXIGA

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SponsorPhase
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 4
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 4
Karolinska University HospitalPhase 3

See all FARXIGA clinical trials

Pharmacology for FARXIGA
Paragraph IV (Patent) Challenges for FARXIGA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FARXIGA Tablets dapagliflozin 5 mg and 10 mg 202293 20 2018-01-08

US Patents and Regulatory Information for FARXIGA

FARXIGA is protected by twenty-one US patents and two FDA Regulatory Exclusivities.

Patents protecting FARXIGA

Methods of treating heart failure with reduced ejection fraction
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION AND WITHOUT TYPE II DIABETES


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE AND URGENT HEART FAILURE VISITS IN ADULTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION AND WITHOUT TYPE II DIABETES

C-aryl glucoside SGLT2 inhibitors and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

C-aryl glucoside SGLT2 inhibitors and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Polymer-based sustained release device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystal structures of SGLT2 inhibitors and processes for preparing same
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Patent Expiration: ⤷  Try a Trial

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods for treating diabetes and reducing body weight
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCING HBA1C IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4

Methods for treating diabetes and reducing body weight
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Methods for treating diabetes and reducing body weight
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCING FASTING PLASMA GLUCOSE IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Polymer-based sustained release device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Polymer-based sustained release device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
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Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE

Pharmaceutical formulations containing an SGLT2 inhibitor
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Patent Expiration: ⤷  Try a Trial

Ampoule comprising an ampoule holder
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Patent Expiration: ⤷  Try a Trial

Method for treating diabetes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Polymer-based sustained release device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

FDA Regulatory Exclusivity protecting FARXIGA

TO REDUCE THE RISK OF SUSTAINED EGFR DECLINE, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION
Exclusivity Expiration: ⤷  Try a Trial

LABELING REVISIONS RELATED TO STUDY D1699CC00001
Exclusivity Expiration: ⤷  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
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

Expired US Patents for FARXIGA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for FARXIGA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AstraZeneca AB Forxiga dapagliflozin EMEA/H/C/002322
Type 2 diabetes mellitusForxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureForxiga is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseForxiga is indicated in adults for the treatment of chronic kidney disease.
Authorised no no no 2012-11-11
AstraZeneca AB Edistride dapagliflozin EMEA/H/C/004161
Type 2 diabetes mellitusEdistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureEdistride is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseEdistride is indicated in adults for the treatment of chronic kidney disease.
Authorised no no no 2015-11-09
Viatris Limited Dapagliflozin Viatris dapagliflozin EMEA/H/C/006006
Type 2 diabetes mellitusDapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance.- in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureDapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.Chronic kidney diseaseDapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.
Authorised yes no no 2023-03-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for FARXIGA

When does loss-of-exclusivity occur for FARXIGA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1730
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 07265246
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0713544
Estimated Expiration: ⤷  Try a Trial

Patent: 2017015106
Estimated Expiration: ⤷  Try a Trial

Patent: 2017021516
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 53344
Estimated Expiration: ⤷  Try a Trial

Patent: 24318
Estimated Expiration: ⤷  Try a Trial

Patent: 85797
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 07001915
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1479287
Estimated Expiration: ⤷  Try a Trial

Patent: 3145773
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 60299
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0141007
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 15738
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 69374
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 8229
Estimated Expiration: ⤷  Try a Trial

Patent: 0428
Estimated Expiration: ⤷  Try a Trial

Patent: 8259
Estimated Expiration: ⤷  Try a Trial

Patent: 5999
Estimated Expiration: ⤷  Try a Trial

Patent: 0900066
Estimated Expiration: ⤷  Try a Trial

Patent: 1171333
Estimated Expiration: ⤷  Try a Trial

Patent: 1490902
Estimated Expiration: ⤷  Try a Trial

Patent: 1791254
Estimated Expiration: ⤷  Try a Trial

Patent: 2091391
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 69374
Estimated Expiration: ⤷  Try a Trial

Patent: 57918
Estimated Expiration: ⤷  Try a Trial

Patent: 45466
Estimated Expiration: ⤷  Try a Trial

Patent: 63807
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 27359
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 5882
Estimated Expiration: ⤷  Try a Trial

Patent: 4180
Estimated Expiration: ⤷  Try a Trial

Patent: 4181
Estimated Expiration: ⤷  Try a Trial

Patent: 4182
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 13889
Estimated Expiration: ⤷  Try a Trial

Patent: 66651
Estimated Expiration: ⤷  Try a Trial

Patent: 37187
Estimated Expiration: ⤷  Try a Trial

Patent: 09545525
Estimated Expiration: ⤷  Try a Trial

Patent: 13209394
Estimated Expiration: ⤷  Try a Trial

Patent: 15071636
Estimated Expiration: ⤷  Try a Trial

Patent: 16172758
Estimated Expiration: ⤷  Try a Trial

Patent: 17222681
Estimated Expiration: ⤷  Try a Trial

Patent: 19059779
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 8566
Estimated Expiration: ⤷  Try a Trial

Patent: 3930
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 9143
Estimated Expiration: ⤷  Try a Trial

Patent: 7155
Estimated Expiration: ⤷  Try a Trial

Patent: 08015377
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4346
Estimated Expiration: ⤷  Try a Trial

Patent: 9190
Estimated Expiration: ⤷  Try a Trial

Patent: 9195
Estimated Expiration: ⤷  Try a Trial

Patent: 9202
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 6828
Estimated Expiration: ⤷  Try a Trial

Patent: 085169
Estimated Expiration: ⤷  Try a Trial

Patent: 221233
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 080349
Estimated Expiration: ⤷  Try a Trial

Patent: 120776
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 012500168
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 69374
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 69374
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 638
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 2741
Estimated Expiration: ⤷  Try a Trial

Patent: 201402181S
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 69374
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0810475
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1493102
Estimated Expiration: ⤷  Try a Trial

Patent: 090023643
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 21665
Estimated Expiration: ⤷  Try a Trial

Patent: 59862
Estimated Expiration: ⤷  Try a Trial

Patent: 69130
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 21245
Estimated Expiration: ⤷  Try a Trial

Patent: 66876
Estimated Expiration: ⤷  Try a Trial

Patent: 19528
Estimated Expiration: ⤷  Try a Trial

Patent: 0811127
Estimated Expiration: ⤷  Try a Trial

Patent: 1406743
Estimated Expiration: ⤷  Try a Trial

Patent: 1509927
Estimated Expiration: ⤷  Try a Trial

Patent: 1546054
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 765
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 FARXIGA around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1958623 Microcapsules à libération prolongée à base de poly(Lactide-Co-Glycolide) comportant un polypeptide et un sucre (Poly(Lactide-Co-Glycolide)-based sustained release microcapsules comprising a polypeptide and a sugar) ⤷  Try a Trial
Portugal 2508188 ⤷  Try a Trial
Mexico 2008002370 EXENDINA PARA TRATAR LA DIABETES Y REDUCIR EL PESO DEL CUERPO. (EXENDIN FOR TREATING DIABETES AND REDUCING BODY WEIGHT.) ⤷  Try a Trial
European Patent Office 1754469 Suspensions injectables ayant des charactéristiques d'injectabilité ameliorées (Injectable suspensions having improved injectability properties) ⤷  Try a Trial
Spain 2278589 ⤷  Try a Trial
Australia 2008228714 Pharmaceutical formulations containing dapagliflozin propylene glycol hydrate ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FARXIGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 132014902277722 Italy ⤷  Try a Trial PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
1506211 CA 2014 00037 Denmark ⤷  Try a Trial PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1734971 C 2012 010 Romania ⤷  Try a Trial PRODUCT NAME: EXENATIDA; NATIONAL AUTHORISATION NUMBER: EU/1/11/696/001, EU/1/11/696/002; DATE OF NATIONAL AUTHORISATION: 20110623; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/696/001, EMEA EU/1/11/696/002; DATE OF FIRST AUTHORISATION IN EEA: 20110623
1506211 C20140021 00131 Estonia ⤷  Try a Trial PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
1506211 1390017-0 Sweden ⤷  Try a Trial PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
1734971 PA2012006 Lithuania ⤷  Try a Trial PRODUCT NAME: EXENATIDUM; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110617
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.