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Last Updated: October 12, 2024

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TRELEGY ELLIPTA Drug Patent Profile


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Which patents cover Trelegy Ellipta, and what generic alternatives are available?

Trelegy Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are twelve patents protecting this drug.

This drug has three hundred and twenty-nine patent family members in forty-eight countries.

The generic ingredient in TRELEGY ELLIPTA is fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; umeclidinium bromide; vilanterol trifenatate profile page.

DrugPatentWatch® Generic Entry Outlook for Trelegy Ellipta

Trelegy Ellipta was eligible for patent challenges on May 10, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 29, 2030. This may change due to patent challenges or generic licensing.

There have been two 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 TRELEGY ELLIPTA
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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRELEGY ELLIPTA
Generic Entry Date for TRELEGY ELLIPTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INHALATION

*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 TRELEGY ELLIPTA

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

SponsorPhase
Baylor Research InstitutePhase 4
GlaxoSmithKlinePhase 4

See all TRELEGY ELLIPTA clinical trials

US Patents and Regulatory Information for TRELEGY ELLIPTA

TRELEGY ELLIPTA is protected by thirteen US patents.

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

Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) COMPRISING THE ONCE PER DAY ADMINISTRATION OF TRELEGY ELLIPTA, 100 MCG FLUTICASONE FUROATE/62.5 MCG UMECLIDINIUM/25 MCG VILANTEROL

Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Medicament dispenser
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA INHALATION

Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION

Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION

Medicament dispenser
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Manifold for use in medicament dispenser
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Medicament dispenser
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Medicament dispenser
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
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
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 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

Expired US Patents for TRELEGY ELLIPTA

International Patents for TRELEGY ELLIPTA

When does loss-of-exclusivity occur for TRELEGY ELLIPTA?

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

Australia

Patent: 10326798
Patent: Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Estimated Expiration: ⤷  Sign Up

Patent: 14204459
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷  Sign Up

Patent: 16262698
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷  Sign Up

Patent: 17238392
Patent: Mannose-derived antagonists of FimH useful for treating disease
Estimated Expiration: ⤷  Sign Up

Patent: 18282427
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷  Sign Up

Patent: 21204302
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷  Sign Up

Patent: 23219901
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012012925
Patent: produto de combinação farmacêutico, inalador de pó seco, e, uso de um produto
Estimated Expiration: ⤷  Sign Up

Patent: 2018069147
Patent: composto da fórmula iii, composição farmacêutica, método de inibição da função de fimh e método de tratamento de uma doença mediada por fimh
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 81487
Patent: COMBINAISONS D'UN ANTAGONISTE DE RECEPTEUR MUSCARINIQUE ET D'UN AGONISTE DU RECEPTEUR BETA-2 ADRENERGIQUE (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷  Sign Up

Patent: 18345
Patent: ANTAGONISTES DERIVES DU MANNOSE DE FIMH UTILES POUR LE TRAITEMENT D'UNE MALADIE (MANNOSE-DERIVED ANTAGONISTS OF FIMH USEFUL FOR TREATING DISEASE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 12001432
Patent: Producto de combinacion farmacéutica que comprende bromuro de 4-[hidroxi-(difenil)-metil]-1-{2-[(fenil-metil)-oxi]-etil}-1-azonia-biciclo-[2.2.2]-octano y trifenil-acetato de 4-{(1r)-2-[(6-{2-[(2,6-dicloro-bencil)-oxi]-etoxi}-hexil)-amino]-1-hidroxi-etil}-2-(hidroxi-metil)-fenol; y su uso para tratar enfermedades respiratorias.
Estimated Expiration: ⤷  Sign Up

China

Patent: 2724974
Patent: Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Estimated Expiration: ⤷  Sign Up

Patent: 7412229
Patent: 毒蕈碱受体拮抗剂和β‑2肾上腺素受体激动剂的组合 (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷  Sign Up

Patent: 8778288
Patent: 可用于治疗疾病的FimH的甘露糖衍生的拮抗剂 (Mannose-derived antagonists of FimH useful for treating disease)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 41613
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARÍNICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA 2
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 120265
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARÍNICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0180312
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 20058
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 06844
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 012000148
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARINICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 3839
Patent: КОМБИНАЦИИ АНТАГОНИСТА МУСКАРИНОВЫХ РЕЦЕПТОРОВ И АГОНИСТА БЕТА-2-АДРЕНОРЕЦЕПТОРОВ (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷  Sign Up

Patent: 1290266
Patent: КОМБИНАЦИИ АНТАГОНИСТА МУСКАРИНОВЫХ РЕЦЕПТОРОВ И АГОНИСТА БЕТА-2-АДРЕНОРЕЦЕПТОРОВ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 06844
Patent: Combinaisons d'un antagoniste de récepteur muscarinique et d'un agoniste du récepteur bêta-2 adrénergique (Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist)
Estimated Expiration: ⤷  Sign Up

Patent: 35707
Patent: COMBINAISONS D'UN ANTAGONISTE DE RÉCEPTEUR MUSCARINIQUE ET D'UN AGONISTE DU RÉCEPTEUR BÊTA-2 ADRÉNERGIQUE (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷  Sign Up

Patent: 32892
Patent: ANTAGONISTES DÉRIVÉS DU MANNOSE DE FIMH UTILES POUR LE TRAITEMENT D'UNE MALADIE (MANNOSE-DERIVED ANTAGONISTS OF FIMH USEFUL FOR TREATING DISEASE)
Estimated Expiration: ⤷  Sign Up

France

Patent: C1022
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 49407
Patent: 毒蕈碱受體拮抗劑和β-2腎上腺素受體激動劑的組合 (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 36216
Estimated Expiration: ⤷  Sign Up

Patent: 800027
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 9893
Patent: שילובים של אנטגוניסט לקולטן מוסקריני ואגוניסט לקולטן בתא-2-אדרנו (Combinations of a muscarinic receptor antagonist and a beta-2 adrenorecptor agonist)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 16631
Estimated Expiration: ⤷  Sign Up

Patent: 13512270
Estimated Expiration: ⤷  Sign Up

Patent: 19509315
Patent: 疾患の処置に有用なFimHのマンノース由来アンタゴニスト
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 506844
Estimated Expiration: ⤷  Sign Up

Patent: 2018011
Estimated Expiration: ⤷  Sign Up

Patent: 06844
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 0077
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 4864
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 1290
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARÍNICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2. (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST.)
Estimated Expiration: ⤷  Sign Up

Patent: 12006310
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARINICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2. (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST.)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 965
Patent: KOMBINACIJE ANTAGONISTA MUSKARINSKOG RECEPTORA I AGONISTA ВЕТА - 2 ADRENORECEPTORA (Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 853
Patent: تركيبة مضاد استقبال المسكارينية ومحضر استقبال بتي ـ 2 الأدرينالية
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0026
Patent: Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 06844
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 130042
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARINICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2
Estimated Expiration: ⤷  Sign Up

Patent: 170915
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARINICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 06844
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 06844
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 18131440
Patent: Антагонисты FimH, являющиеся производными маннозы, пригодные для лечения заболевания
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 848
Patent: KOMBINACIJE ANTAGONISTA MUSKARINSKOG RECEPTORA I AGONISTA BETA-2 ADRENORECEPTORA (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 1087
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷  Sign Up

Patent: 201407864U
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 06844
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1203890
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1742140
Estimated Expiration: ⤷  Sign Up

Patent: 1830728
Estimated Expiration: ⤷  Sign Up

Patent: 120092163
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷  Sign Up

Patent: 170061719
Patent: 무스카린성 수용체 길항제 및 베타-2 아드레날린 수용체 효능제의 조합물 (- COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷  Sign Up

Patent: 180128937
Patent: 질환을 치료하는데 유용한 FIMH의 만노스-유래 길항제
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 59330
Estimated Expiration: ⤷  Sign Up

Turkey

Patent: 1802921
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 6775
Patent: КОМБІНАЦІЯ АНТАГОНІСТА МУСКАРИНОВОГО РЕЦЕПТОРА ТА АГОНІСТА БЕТА-2 АДРЕНОРЕЦЕПТОРА (COMBINATIONS OF MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONIST AND BETA 2 AGONIST)
Estimated Expiration: ⤷  Sign Up

United Kingdom

Patent: 21075
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 TRELEGY ELLIPTA around the world.

Country Patent Number Title Estimated Expiration
Norway 333813 ⤷  Sign Up
China 102724974 Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist ⤷  Sign Up
Norway 342072 ⤷  Sign Up
Brazil 0312725 ⤷  Sign Up
Slovenia 1775305 ⤷  Sign Up
Mexico 2008001250 DOSIFICADOR DE MEDICAMENTO. (MEDICAMENT DISPENSER.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRELEGY ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1425001 CA 2014 00021 Denmark ⤷  Sign Up PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113
1519731 132013902182575 Italy ⤷  Sign Up PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1740177 300694 Netherlands ⤷  Sign Up PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430
1305329 300343 Netherlands ⤷  Sign Up 300343, 20210803, EXPIRES: 20230110
1740177 PA2014038 Lithuania ⤷  Sign Up PRODUCT NAME: UMECLIDINIUM BROMIDIUM; REGISTRATION NO/DATE: EU/1/14/922 20140428
1425001 C300664 Netherlands ⤷  Sign Up PRODUCT NAME: VILANTEROL, DAN WEL EEN ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TRIFENYLACETAATZOUT; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
>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.