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Last Updated: November 23, 2024

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SUNOSI Drug Patent Profile


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

Sunosi is a drug marketed by Axsome Malta and is included in one NDA. There are thirty-five patents protecting this drug and one Paragraph IV challenge.

This drug has seventy patent family members in twenty-three countries.

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

DrugPatentWatch® Generic Entry Outlook for Sunosi

Sunosi was eligible for patent challenges on June 17, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 5, 2037. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 SUNOSI
Drug Prices for SUNOSI

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SUNOSI
Generic Entry Date for SUNOSI*:
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 SUNOSI

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

SponsorPhase
Axsome Therapeutics, Inc.Phase 2
Johns Hopkins UniversityPhase 2
National Multiple Sclerosis SocietyPhase 2

See all SUNOSI clinical trials

Paragraph IV (Patent) Challenges for SUNOSI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUNOSI Tablets solriamfetol hydrochloride 75 mg and 150 mg 211230 6 2023-06-20

US Patents and Regulatory Information for SUNOSI

SUNOSI is protected by thirty-five US patents and two FDA Regulatory Exclusivities.

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

Formulations of (R)-2-amino-3-phenylpropyl carbamate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Treatment of sleep-wake disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)

Formulations of (R)-2-amino-3-phenylpropyl carbamate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)

Methods and compositions for treating excessive sleepiness
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH OBSTRUCTIVE SLEEP APNEA (OSA) IN AN ADULT THROUGH A DOSING REGIMEN THAT INCLUDES ORAL ADMINISTRATION OF 75 MG ONCE DAILY FOR AT LEAST 3 DAYS FOLLOWED BY 150 MG ONCE DAILY

Methods of providing solriamfetol therapy to subjects with impaired renal function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH OBSTRUCTIVE SLEEP APNEA (OSA) IN A PATIENT WITH MODERATE RENAL IMPAIRMENT

Methods and compositions for treating excessive sleepiness
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) WITH A DOSING REGIMEN THAT INCLUDES A DOSE OF 75 MG ONCE DAILY FOR AT LEAST 3 DAYS FOLLOWED BY 150 MG ONCE DAILY

Methods of providing solriamfetol therapy to subjects with impaired renal function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT

Formulations of (R)-2-amino-3-phenylpropyl carbamate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING A COMPOSITION COMPRISING SOLRIAMFETOL HYDROCHLORIDE AND 2-CHLOROPROPANE, WHEREIN THE COMPOSITION COMPRISES LESS THAN ABOUT 5 PPM 2‑CHLOROPROPANE


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS WITH A DOSING REGIMEN THAT INCLUDES ORAL ADMINISTRATION OF 75 MG ONCE DAILY FOR AT LEAST 3 DAYS FOLLOWED BY 150 MG ONCE DAILY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MODERATE OR SEVERE RENAL IMPAIRMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING OBSTRUCTIVE SLEEP APNEA (OSA) AND NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING A HISTORY OF BIPOLAR DISORDERS AND MODERATE OR SEVERE RENAL IMPAIRMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL

Treatment of sleep-wake disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)

Treatment of sleep-wake disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)

Treatment of sleep-wake disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)

FDA Regulatory Exclusivity protecting SUNOSI

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

INDICATED TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY
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
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  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 SUNOSI

When does loss-of-exclusivity occur for SUNOSI?

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

Australia

Patent: 17324855
Patent: Formulations of ( R)-2-amino-3-phenylpropyl carbamate
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 36068
Patent: FORMULATIONS DE (R)-2-AMINO-3-PHENYLPROPYL-CARBAMATE (FORMULATIONS OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 19000571
Patent: Formulaciones de carbamato de (r) -2-amino-3-fenilpropilo.
Estimated Expiration: ⤷  Sign Up

China

Patent: 9906078
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 09581
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 09581
Patent: FORMULATIONS DE (R (FORMULATIONS OF (R)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 09581
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 5193
Patent: פורמולות של (r) -2- אמינו - 3- פאנילפרופיל קארבאמאט (Formulations of (r)-2-amino-3-phenylpropyl carbamate)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 48498
Estimated Expiration: ⤷  Sign Up

Patent: 19533640
Patent: (R)−2−アミノ−3−フェニルプロピルカルバメートの製剤
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 7631
Patent: FORMULATIONS OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 19002606
Patent: FORMULACIONES DE (R)-2-AMINO-3-FENILPROPIL CARBAMATO. (FORMULATIONS OF ( R)-2-AMINO-3-PHENYLPROPYL CARBAMATE.)
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 019500494
Patent: FORMULATIONS OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 64576
Patent: СОСТАВЫ (R)-2-АМИНО-3-ФЕНИЛПРОПИЛКАРБАМАТА ((R)-2-AMINO-3-PHENYLPROPYL CARBAMATE FORMULAS)
Estimated Expiration: ⤷  Sign Up

Patent: 19110127
Patent: СОСТАВЫ (R)-2-АМИНО-3-ФЕНИЛПРОПИЛ КАРБАМАТА
Estimated Expiration: ⤷  Sign Up

Saudi Arabia

Patent: 9401246
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201901996U
Patent: FORMULATIONS OF ( R)-2-AMINO-3-PHENYLPROPYL CARBAMATE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2464646
Estimated Expiration: ⤷  Sign Up

Patent: 190104510
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 37795
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 SUNOSI around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2018048871 ⤷  Sign Up
Russian Federation 2417077 СПОСОБ ЛЕЧЕНИЯ ЧРЕЗМЕРНОЙ ДНЕВНОЙ СОНЛИВОСТИ (ВАРИАНТЫ) (METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS (VERSIONS)) ⤷  Sign Up
Russian Federation 2764576 СОСТАВЫ (R)-2-АМИНО-3-ФЕНИЛПРОПИЛКАРБАМАТА ((R)-2-AMINO-3-PHENYLPROPYL CARBAMATE FORMULAS) ⤷  Sign Up
Australia 2006254899 Treatment of sleep-wake disorders ⤷  Sign Up
Denmark 1890684 ⤷  Sign Up
Taiwan 200716084 Methods for treating sleep-wake disorders ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SUNOSI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1890684 14/2020 Austria ⤷  Sign Up PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, VORZUGSWEISE EIN HYDROCHLORIDSALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1408 (MITTEILUNG) 20200120
1890684 CR 2020 00016 Denmark ⤷  Sign Up PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET HYDROCHLORIDSALT DERAF; REG. NO/DATE: EU/1/19/1408 20200120
1890684 20C1014 France ⤷  Sign Up PRODUCT NAME: SOLRIAMFETOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, DE PREFERENCE UN SEL DE CHLORHYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1408 20200120
1890684 SPC/GB20/017 United Kingdom ⤷  Sign Up PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A HYDROCHLORIDE SALT THEREOF; REGISTERED: UK EU/1/19/1408 (NI) 20200120; UK PLGB 31626/0003 20200120; UK PLGB 31626/0002 20200120
1890684 122020000015 Germany ⤷  Sign Up PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, BEVORZUGT EIN HYDROCHLORIDSALZ DAVON.; REGISTRATION NO/DATE: EU/1/19/1408 20200116
1890684 2020C/004 Belgium ⤷  Sign Up PRODUCT NAME: SOLRIAMFETOL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR EEN HYDROCHLORIDE ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1408 20200120
>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.