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Last Updated: September 27, 2022

CALQUENCE Drug Patent Profile


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Which patents cover Calquence, and when can generic versions of Calquence launch?

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

This drug has one hundred and fifty-nine patent family members in forty-eight countries.

The generic ingredient in CALQUENCE is acalabrutinib. One supplier is listed for this compound. Additional details are available on the acalabrutinib profile page.

DrugPatentWatch® Generic Entry Outlook for Calquence

Calquence was eligible for patent challenges on October 31, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 1, 2036. This may change due to patent challenges or generic licensing.

There have been six 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

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Drug patent expirations by year for CALQUENCE
Drug Prices for CALQUENCE

See drug prices for CALQUENCE

DrugPatentWatch® Estimated Generic Entry Opportunity Date for CALQUENCE
Generic Entry Date for CALQUENCE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 CALQUENCE

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

SponsorPhase
Ohio State University Comprehensive Cancer CenterPhase 2
Jonsson Comprehensive Cancer CenterPhase 1/Phase 2
German CLL Study GroupPhase 3

See all CALQUENCE clinical trials

Pharmacology for CALQUENCE
Drug ClassKinase Inhibitor
Mechanism of Action Tyrosine Kinase Inhibitors
Paragraph IV (Patent) Challenges for CALQUENCE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CALQUENCE Capsules acalabrutinib 100 mg 210259 5 2021-11-01

US Patents and Regulatory Information for CALQUENCE

CALQUENCE is protected by twenty-six US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CALQUENCE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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 CALQUENCE

Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA

Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA

Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100MG OF ACALABRUTINIB TWICE DAILY

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY IN COMBINATION WITH OBINUTUZUMAB

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100MG OF ACALABRUTINIB TWICE DAILY

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY IN COMBINATION WITH OBINUTUZUMAB

Imidazopyrazine tyrosine kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as Btk inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

4-imidazopyridazin-1-yl-benzamides as Btk inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA

Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA

FDA Regulatory Exclusivity protecting CALQUENCE

TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 CALQUENCE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AstraZeneca AB Calquence acalabrutinib EMEA/H/C/005299
Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Authorised no no no 2020-11-05
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for CALQUENCE

When does loss-of-exclusivity occur for CALQUENCE?

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

Australia

Patent: 16286548
Estimated Expiration: See Plans and Pricing

Patent: 20277123
Estimated Expiration: See Plans and Pricing

Canada

Patent: 91096
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17003445
Estimated Expiration: See Plans and Pricing

China

Patent: 8349978
Estimated Expiration: See Plans and Pricing

Patent: 3480542
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0200934
Estimated Expiration: See Plans and Pricing

Patent: 0211511
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 17281
Estimated Expiration: See Plans and Pricing

Patent: 13745
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 17281
Estimated Expiration: See Plans and Pricing

Patent: 13745
Estimated Expiration: See Plans and Pricing

Patent: 54690
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 50511
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 49989
Estimated Expiration: See Plans and Pricing

Patent: 56008
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6633
Estimated Expiration: See Plans and Pricing

Patent: 4066
Estimated Expiration: See Plans and Pricing

Japan

Patent: 29215
Estimated Expiration: See Plans and Pricing

Patent: 18522877
Estimated Expiration: See Plans and Pricing

Patent: 21073235
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 17281
Estimated Expiration: See Plans and Pricing

Patent: 13745
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 18000179
Estimated Expiration: See Plans and Pricing

Moldova, Republic of

Patent: 17281
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 297
Estimated Expiration: See Plans and Pricing

Patent: 817
Estimated Expiration: See Plans and Pricing

Poland

Patent: 17281
Estimated Expiration: See Plans and Pricing

Patent: 13745
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 17281
Estimated Expiration: See Plans and Pricing

Patent: 13745
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 18103913
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 411
Estimated Expiration: See Plans and Pricing

Patent: 455
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201913796U
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 17281
Estimated Expiration: See Plans and Pricing

Patent: 13745
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1800329
Estimated Expiration: See Plans and Pricing

Patent: 2000300
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 180048593
Estimated Expiration: See Plans and Pricing

Spain

Patent: 97987
Estimated Expiration: See Plans and Pricing

Patent: 95802
Estimated Expiration: See Plans and Pricing

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 CALQUENCE around the world.

Country Patent Number Title Estimated Expiration
Taiwan 201628620 Compositions and methods for treatment of chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor See Plans and Pricing
South Korea 20060086987 IMIDAZOPYRAZINE TYROSINE KINASE INHIBITORS See Plans and Pricing
Brazil 112014001255 composto, uso de um composto, combinação, e, composição farmacêutica See Plans and Pricing
Serbia 62760 4-IMIDAZOPIRIDAZIN-1-IL-BENZAMIDI I 4-IMIDAZOTRIAZIN-1-IL-BENZAMIDI KAO INHIBITORI BTK (4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK-INHIBITORS) See Plans and Pricing
Eurasian Patent Organization 201992270 4-ИМИДАЗОПИРИДАЗИН-1-ИЛ-БЕНЗАМИДЫ И 4-ИМИДАЗОТРИАЗИН-1-ИЛ-БЕНЗАМИДЫ В КАЧЕСТВЕ BTK-ИНГИБИТОРОВ See Plans and Pricing
Hungary E056008 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CALQUENCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2734522 PA2021004 Lithuania See Plans and Pricing PRODUCT NAME: AKALABRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105
2734522 2021C/512 Belgium See Plans and Pricing PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
2734522 301097 Netherlands See Plans and Pricing PRODUCT NAME: ACALABRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/20/1479 20201106
2734522 122021000020 Germany See Plans and Pricing PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1479 20201105
2734522 132021000000047 Italy See Plans and Pricing PRODUCT NAME: ACALABRUTINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(CALQUENCE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1479, 20201106
2734522 C02734522/01 Switzerland See Plans and Pricing PRODUCT NAME: ACALABRUTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67790 04.03.2021
>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.