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Last Updated: July 16, 2024

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SIVEXTRO Drug Patent Profile


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When do Sivextro patents expire, and what generic alternatives are available?

Sivextro is a drug marketed by Cubist Pharms Llc and is included in two NDAs. There are seven patents protecting this drug.

This drug has seventy-eight patent family members in thirty-nine countries.

The generic ingredient in SIVEXTRO is tedizolid phosphate. Two suppliers are listed for this compound. Additional details are available on the tedizolid phosphate profile page.

DrugPatentWatch® Generic Entry Outlook for Sivextro

Sivextro was eligible for patent challenges on June 20, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 31, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SIVEXTRO
International Patents:78
US Patents:7
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 59
Clinical Trials: 5
Patent Applications: 88
Drug Prices: Drug price information for SIVEXTRO
What excipients (inactive ingredients) are in SIVEXTRO?SIVEXTRO excipients list
DailyMed Link:SIVEXTRO at DailyMed
Drug patent expirations by year for SIVEXTRO
Drug Prices for SIVEXTRO

See drug prices for SIVEXTRO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SIVEXTRO
Generic Entry Dates for SIVEXTRO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS
Generic Entry Dates for SIVEXTRO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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.

Recent Clinical Trials for SIVEXTRO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterPhase 2
Los Angeles Biomedical Research InstitutePhase 2

See all SIVEXTRO clinical trials

Pharmacology for SIVEXTRO

US Patents and Regulatory Information for SIVEXTRO

SIVEXTRO is protected by seven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIVEXTRO 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 SIVEXTRO

Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5- -hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Oxazolidinone derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSSI) CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA

Oxazolidinone derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS

Crystalline form of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxy- methyl oxazolidin-2-one dihydrogen phosphate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS

Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5- -hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSSI) CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA

Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5- -hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting SIVEXTRO

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
Cubist Pharms Llc SIVEXTRO tedizolid phosphate POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Cubist Pharms Llc SIVEXTRO tedizolid phosphate TABLET;ORAL 205435-001 Jun 20, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cubist Pharms Llc SIVEXTRO tedizolid phosphate POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 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

EU/EMA Drug Approvals for SIVEXTRO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp & Dohme B.V. Sivextro tedizolid phosphate EMEA/H/C/002846
Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older.
Authorised no no no 2015-03-23
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SIVEXTRO

When does loss-of-exclusivity occur for SIVEXTRO?

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

African Regional IP Organization (ARIPO)

Patent: 87
Patent: Crystalline form of (R)-3-(-4(2-(2-methyltetrazol-5-YL)pyridin-5-YL)-3-fluorophenyl)-5-hydroxymethyloxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 10210627
Patent: Crystalline form of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 1008829
Patent: forma cristalina de dihidrogenofosfato de (r)-3-(4-(2-(2-metiltetrazol-5-il) piridin-5-il)-3-fluorofenil)-5-hidroximetil oxazolidin-2-ona
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 51392
Patent: FORME CRISTALLINE DU DIHYDROGENOPHOSPHATE DE (R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE (CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 11001855
Patent: Partículas cristalinas que comprenden al compuesto fosfato de dihidrógeno de (r)-3-(4-(2-(2-metiltetrazol-5-il)piridin-5-il)-3-fluorofenil)-5-hidroximetil oxazolidin-2-ona; proceso de preparación; mezcla que la comprende; composición farmacéutica; y su uso para tratar una infección bacteriana.
Estimated Expiration: ⤷  Sign Up

China

Patent: 2439006
Patent: Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷  Sign Up

Patent: 7082790
Patent: 种噁唑烷酮化合物的晶型 (Crystalline form of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 20071
Patent: Forma cristalina del fosfato de dihidrogeno r)-3-(4-(2-(2-metiltetrazol-5-il)piridin-5-il)-3-fluorofenil)-5-hidroximetil oxazolidin-2-ona
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 110464
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTETRAZOL-5-IL)PIRIDIN-5-IL)-3-FLUOROFENIL)-5- HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷  Sign Up

Cuba

Patent: 089
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDRÓGENO R)-3-(4-(2-(2-METILTRETAZOL-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷  Sign Up

Patent: 110155
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDRÓGENO R)-3-(4-(2-(2-METILTRETAZOL-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 011000251
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTETRAZOL-5-IL) PIRIDIN-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 11011285
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTETRAZOL-5-IL)PIRIDIN-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 93808
Patent: FORME CRISTALLINE DU DIHYDROGÉNOPHOSPHATE DE (R)-3-(4-(2-(2-MÉTHYLTÉTRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHÉNYL)-5-HYDROXYMÉTHYL OXAZOLIDIN-2-ONE (CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 4401
Patent: צורה גבישית של (r)-3-(4-(2-(2-מתילטטראזול-5-יל)פירידין-5-יל)-3-פלואורופניל)-5-הידרוקסימתיל אוקסאזולידין-2-און דיהידרוגן פוספאט (Crystalline form of (r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 84705
Estimated Expiration: ⤷  Sign Up

Patent: 12516894
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 6354
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 11008093
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTET RAZOL-5-IL)PIRIDIN-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA. (CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-Y L)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE.)
Estimated Expiration: ⤷  Sign Up

Patent: 20011773
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTET RAZOL-5-IL)PIRIDIN-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA. (CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-Y L)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 092
Patent: FORME CRISTALLINE DU DIHYDROGÉNOPHOSPHATE DE (R)-3-(4-(2-(2-MÉTHYLTÉTRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHÉNYL)-5-HYDROXYMÉTHYL OXAZOLIDIN-2-ONE
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4408
Patent: Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷  Sign Up

Patent: 0458
Patent: Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷  Sign Up

Patent: 2289
Patent: Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 120585
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTETRAZOL-5-IL) PIRIDIN-5-IL)-3-FLUOROFENSIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 014500092
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 55928
Patent: Кристаллические частицы для приготовления твердых лекарственных форм для лечения бактериальных инфекций, реакционная смесь, содержащая такие частицы, и фармацевтическая композиция для лечения бактериальных инфекций (CRYSTALLINE PARTICLES FOR PREPARATION OF SOLID DOSAGE FORMS FOR TREATMENT OF BACTERIAL INFECTIONS, REACTION MIXTURE CONTAINING SUCH PARTICLES, AND PHARMACEUTICAL COMPOSITION FOR TREATING BACTERIAL INFECTIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 11136537
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА (R)-3-(4-(2-МЕТИЛТЕТРАЗОЛ-5-ИЛ)ПИРИДИН-5-ИЛ)-3-ФТОРФЕНИЛ)-5-ГИДРОКСИМЕТИЛ ОКСАЗОЛИДИН-2-ОН ДИВОДОРОД ФОСФАТА
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 3497
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷  Sign Up

Patent: 201500207Q
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1106412
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷  Sign Up

Patent: 1306536
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1739923
Estimated Expiration: ⤷  Sign Up

Patent: 1918678
Estimated Expiration: ⤷  Sign Up

Patent: 110120311
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷  Sign Up

Patent: 170040371
Patent: R)-3--5-히드록시메틸 옥사졸리딘-2-온 디히드로겐 포스페이트의 결정형 (-3-4-2-2--5--5--3--5- -2- Crystalline form of R-3-4-2-2-methyltetrazol-5-ylpyridin-5-yl-3-fluorophenyl-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate)
Estimated Expiration: ⤷  Sign Up

Patent: 170135984
Patent: R)-3--5-히드록시메틸 옥사졸리딘-2-온 디히드로겐 포스페이트의 결정형 (-3-4-2-2--5--5--3--5- -2- Crystalline form of R-3-4-2-2-methyltetrazol-5-ylpyridin-5-yl-3-fluorophenyl-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 34724
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 11000381
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 4068
Patent: КРИСТАЛІЧНІ ЧАСТИНКИ (R)-3-(4-(2-(2-МЕТИЛТЕТРАЗОЛ-5-ІЛ)ПІРИДИН-5-ІЛ)-3-ФТОРФЕНІЛ)-5-ГІДРОКСИМЕТИЛОКСАЗОЛІДИН-2-ОНДИВОДЕНЬФОСФАТУ
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 SIVEXTRO around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1153738 OXAZOLIDINONE DERIVATIVES AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME ⤷  Sign Up
Australia 2010210627 Crystalline form of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate ⤷  Sign Up
New Zealand 712289 Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIVEXTRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1699784 PA2015032 Lithuania ⤷  Sign Up PRODUCT NAME: TEDIZOLIDO FOSFATAS; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784 1590047-5 Sweden ⤷  Sign Up PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/991 20150325
1699784 132016000024232 Italy ⤷  Sign Up PRODUCT NAME: TEDIZOLID, FACOLTATIVAMENTE IN FORMA DI ESTERE, IN PARTICOLARE UN FOSFATO, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(SIVEXTRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/991/001, 20150325
>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.