PLENVU Drug Patent Profile
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When do Plenvu patents expire, and what generic alternatives are available?
Plenvu is a drug marketed by Salix and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and fifty-nine patent family members in thirty-seven countries.
The generic ingredient in PLENVU is ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate profile page.
DrugPatentWatch® Generic Entry Outlook for Plenvu
There have been three 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.
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for PLENVU?
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Summary for PLENVU
| International Patents: | 159 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 6 |
| Drug Prices: | Drug price information for PLENVU |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PLENVU |
| What excipients (inactive ingredients) are in PLENVU? | PLENVU excipients list |
| DailyMed Link: | PLENVU at DailyMed |
Recent Clinical Trials for PLENVU
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Odense University Hospital | Phase 3 |
| Lund University | Phase 3 |
| Region Skane | Phase 3 |
Paragraph IV (Patent) Challenges for PLENVU
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PLENVU | For Oral Solution | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | 140 g, 5.2 g, 2.2.g, 48.11 g, 9 g and 7.54 g per pouch | 209381 | 1 | 2018-12-06 |
US Patents and Regulatory Information for PLENVU
PLENVU is protected by eleven US patents.
Patents protecting PLENVU
Compositions
Patent Number: ⤷ Sign Up
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Colonoscopy-preparation
Patent Number: ⤷ Sign Up
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Colonoscopy--preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
Colon cleansing compositions and methods of use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
Compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions
Patent Number: ⤷ Sign Up
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Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
Colonoscopy--preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
Compositions
Patent Number: ⤷ Sign Up
Patent 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Salix | PLENVU | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 209381-001 | May 4, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Salix | PLENVU | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 209381-001 | May 4, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Salix | PLENVU | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 209381-001 | May 4, 2018 | 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 PLENVU
When does loss-of-exclusivity occur for PLENVU?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2500
Patent: SOLUCION DE LIMPIEZA DE COLON
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 13314442
Patent: Compositions comprising PEG and ascorbate
Estimated Expiration: ⤷ Sign Up
Patent: 15228962
Patent: Method of cleansing the colon
Estimated Expiration: ⤷ Sign Up
Patent: 18204694
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015005270
Patent: composições compreendendo peg e ascorbato
Estimated Expiration: ⤷ Sign Up
Patent: 2016019914
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 84472
Patent: COMPOSITIONS (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷ Sign Up
Patent: 42089
Patent: METHODE DE NETTOYAGE DU COLON (METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷ Sign Up
Patent: 16204
Patent: COMPOSITION POUR NETTOYAGE DU COLON COMPRENANT DE L'ASCORBATE ET DU POLYETHYLENEGLYCOL (PEG) (COLON CLEANSING COMPOSITION COMPRISING ASCORBATE AND PEG)
Estimated Expiration: ⤷ Sign Up
China
Patent: 5007915
Patent: Compositions comprising PEG and ascorbate
Estimated Expiration: ⤷ Sign Up
Patent: 6102738
Patent: 清洗结肠的方法 (Method of cleansing the colon)
Estimated Expiration: ⤷ Sign Up
Patent: 5154464
Patent: 清洗结肠的方法 (Method of cleaning colon)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0191007
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 21668
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 95163
Estimated Expiration: ⤷ Sign Up
Patent: 73248
Estimated Expiration: ⤷ Sign Up
Patent: 77850
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 8866
Patent: КОМПОЗИЦИЯ И РАСТВОР ДЛЯ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ, ЛЕКАРСТВЕННОЕ СРЕДСТВО (ВАРИАНТЫ), НАБОР И СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ (COLON CLEANSING COMPOSITION AND SOLUTION, MEDICAMENT (EMBODIMENTS), KIT AND METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷ Sign Up
Patent: 7891
Patent: СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ (METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷ Sign Up
Patent: 1500320
Patent: КОМПОЗИЦИЯ (ВАРИАНТЫ) И РАСТВОР ДЛЯ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ, ЛЕКАРСТВЕННОЕ СРЕДСТВО, НАБОР И СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ (ВАРИАНТЫ)
Estimated Expiration: ⤷ Sign Up
Patent: 1600639
Patent: СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 95163
Patent: COMPOSITIONS COMPRENANT DU PEG ET DE L'ASCORBATE (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷ Sign Up
Patent: 16494
Patent: MÉTHODE DE NETTOYAGE DU CÔLON (METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷ Sign Up
Patent: 73248
Patent: COMPOSITIONS COMPRENANT DU POLYÉTHYLÈNE GLYCOL ET UN MÉTAL ALCALIN OU DES SULFATES MÉTALLIQUES ALCALINOTERREUX DESTINÉS À ÊTRE UTILISÉS EN TANT QUE COMPOSITIONS DE NETTOYAGE DU CÔLON (COMPOSITIONS COMPRISING POLYETHYLENE GLYCOL AND ALKALI METAL OR ALKALINE EARTH METAL SULPHATES FOR USE AS COLON CLEANSING COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 77850
Patent: PROCÉDÉ DE NETTOYAGE DU COLON (METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 06604
Patent: 含聚乙二醇和抗壞血酸鹽的組合物 (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 43605
Estimated Expiration: ⤷ Sign Up
India
Patent: 04DEN2015
Estimated Expiration: ⤷ Sign Up
Ireland
Patent: 0130273
Patent: Compositions comprising PEG and ascorbate
Estimated Expiration: ⤷ Sign Up
Patent: 6410
Patent: Compositions comprising PEG and ascorbate
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7377
Patent: הרכבות המכילות peg ו-ascorbate (Compositions comprising peg and ascorbate)
Estimated Expiration: ⤷ Sign Up
Patent: 7170
Patent: שיטה לשטיפת מעי הגס (Method of cleansing the colon)
Estimated Expiration: ⤷ Sign Up
Patent: 9024
Patent: הרכבות המכילות peg ו-ascorbate (Compositions comprising peg and ascorbate)
Estimated Expiration: ⤷ Sign Up
Patent: 4374
Patent: תמיסה לניקוי של מעי הגס (A colon cleansing solution)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 57675
Estimated Expiration: ⤷ Sign Up
Patent: 55391
Estimated Expiration: ⤷ Sign Up
Patent: 77396
Estimated Expiration: ⤷ Sign Up
Patent: 15527385
Patent: ＰＥＧとアスコルビン酸塩とを含む組成物
Estimated Expiration: ⤷ Sign Up
Patent: 17507965
Patent: 結腸を洗浄する方法
Estimated Expiration: ⤷ Sign Up
Patent: 20073579
Patent: ＰＥＧとアスコルビン酸塩とを含む組成物 (COMPOSITIONS COMPRISING ASCORBATE AND PEG)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 95163
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4758
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷ Sign Up
Patent: 8550
Patent: METHOD OF CLEANSING THE COLON
Estimated Expiration: ⤷ Sign Up
Patent: 3378
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 9318
Patent: COMPOSICIONES QUE COMPRENDEN POLIETILENGLICOL Y ASCORBATO. (COMPOSITIONS COMPRISING PEG AND ASCORBATE.)
Estimated Expiration: ⤷ Sign Up
Patent: 15003031
Patent: COMPOSICIONES QUE COMPRENDEN POLIETILENGLICOL Y ASCORBATO. (COMPOSITIONS COMPRISING PEG AND ASCORBATE.)
Estimated Expiration: ⤷ Sign Up
Patent: 16011256
Patent: METODO PARA EL LAVADO DEL COLON. (METHOD OF CLEANSING THE COLON.)
Estimated Expiration: ⤷ Sign Up
Patent: 21005225
Patent: MÉTODO PARA EL LAVADO DEL COLON. (METHOD OF CLEANSING THE COLON.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 413
Patent: KOMPOZICIJE КОЈЕ SADRŽE PEG I ASKORBAT (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 11424
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5499
Patent: Compositions comprising peg and ascorbate
Estimated Expiration: ⤷ Sign Up
Patent: 3017
Patent: Method of cleansing the colon
Estimated Expiration: ⤷ Sign Up
Patent: 3984
Patent: Compositions comprising polyethylene glycol, alkali metal or alkaline earth metal sulphates and electrolytes for use as colon cleansing compositions
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 95163
Estimated Expiration: ⤷ Sign Up
Patent: 73248
Estimated Expiration: ⤷ Sign Up
Patent: 77850
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 95163
Estimated Expiration: ⤷ Sign Up
Patent: 73248
Estimated Expiration: ⤷ Sign Up
Patent: 77850
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 979
Patent: KOMPOZICIJE KOJE SADRŽE PEG I ASKORBAT (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201702005V
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷ Sign Up
Patent: 201807427R
Patent: METHOD OF CLEANSING THE COLON
Estimated Expiration: ⤷ Sign Up
Patent: 202112138Q
Patent: COMPOSITIONS COMPRISING PEG AND SULPHATE
Estimated Expiration: ⤷ Sign Up
Patent: 201501713X
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷ Sign Up
Patent: 201606834Q
Patent: METHOD OF CLEANSING THE COLON
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 95163
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1501415
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷ Sign Up
Patent: 1603747
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷ Sign Up
Patent: 1605592
Patent: METHOD OF CLEANSING THE COLON
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1771586
Estimated Expiration: ⤷ Sign Up
Patent: 2234803
Estimated Expiration: ⤷ Sign Up
Patent: 2257207
Estimated Expiration: ⤷ Sign Up
Patent: 150054990
Patent: PEG 및 아스코르베이트를 포함하는 조성물 (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷ Sign Up
Patent: 160130488
Patent: 대장 세척 방법 (METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷ Sign Up
Patent: 170098980
Patent: PEG 및 아스코르베이트를 포함하는 조성물 (PEG COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷ Sign Up
Patent: 190137925
Patent: PEG 및 아스코르베이트를 포함하는 조성물 (PEG COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷ Sign Up
Patent: 210063445
Patent: PEG 및 아스코르베이트를 포함하는 조성물 (PEG COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷ Sign Up
Patent: 230010844
Patent: PEG 및 아스코르베이트를 포함하는 조성물 (PEG COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 28459
Estimated Expiration: ⤷ Sign Up
Patent: 31412
Estimated Expiration: ⤷ Sign Up
Patent: 09386
Estimated Expiration: ⤷ Sign Up
Patent: 28719
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 87238
Estimated Expiration: ⤷ Sign Up
Patent: 56623
Estimated Expiration: ⤷ Sign Up
Patent: 1416092
Patent: Compositions
Estimated Expiration: ⤷ Sign Up
Patent: 2017562
Patent: Compositions, solutions, kits and uses for colon cleansing
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 6546
Patent: РОЗЧИН ДЛЯ ОЧИЩЕННЯ ТОВСТОЇ КИШКИ, КОМПОЗИЦІЯ, НАБІР, ЗАСТОСУВАННЯ КОМПОЗИЦІЇ ДЛЯ ОЧИЩЕННЯ ТОВСТОЇ КИШКИ, ЗАСТОСУВАННЯ РОЗЧИНУ ДЛЯ ОЧИЩЕННЯ ТОВСТОЇ КИШКИ (SB-ACTIN TERMINATOR SEQUENCE FOR GENE EXPRESSION IN PLANTS)
Estimated Expiration: ⤷ Sign Up
Patent: 3659
Patent: СПОСІБ ОЧИЩЕННЯ ТОВСТОЇ КИШКИ (METHOD OF CLEANSING THE COLON)
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 PLENVU around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 1206604 | 含聚乙二醇和抗壞血酸鹽的組合物 (COMPOSITIONS COMPRISING PEG AND ASCORBATE) | ⤷ Sign Up |
| Australia | 2017203257 | ⤷ Sign Up | |
| Croatia | P20161544 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PLENVU
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3141251 | 301099 | Netherlands | ⤷ Sign Up | PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016 |
| 3141251 | 132021000000044 | Italy | ⤷ Sign Up | PRODUCT NAME: UN PRODOTTO MEDICINALE COSTITUITO DA UNA COMBINAZIONE DI UNA PRIMA DOSE DI COMPOSIZIONE FARMACEUTICA E UNA SECONDA DOSE DI COMPOSIZIONE FARMACEUTICA, LA PRIMA DOSE DI COMPOSIZIONE FARMACEUTICA E COSTITUITA DAGLI INGREDIENTI ATTIVI POLIETILENGLICOLE, SOLFATO DI SODIO, CLORURO DI SODIO E CLORURO DI POTASSIO E LA SECONDA DOSE DI COMPOSIZIONE FARMACEUTICA E COSTITUITA DAGLI INGREDIENTI ATTIVI POLIETILENGLICOLE, ACIDO ASCORBICO, ASCORBATO DI SODIO, CLORURO DI SODIO E CLORURO DI POTASSIO.(PLENVU); AUTHORISATION NUMBER(S) AND DATE(S): IS/1/17/083/01, 20171016;045671017, 045671029, 045671031, 045671043, 045671056, 20171213 |
| 3141251 | SPC/GB20/075 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS: POLYETHYLENE GLYCOL 3350, SODIUM SULPH; REGISTERED: IS IS/1/17/063/01 20171016; UK PL 20011/0040 20171016 |
| >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.
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