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Last Updated: June 29, 2022

United States: These 35 Drugs Face Patent Expirations and Generic Entry From 2022 - 2023

DrugPatentWatch® Estimated Loss of Exclusivity Dates in the United States

The content of this page is licensed under a Creative Commons Attribution 4.0 International License. Creative Commons License

Preferred citation:
Friedman, Yali, "United States: These 35 Drugs Face Patent Expirations and Generic Entry From 2022 - 2023" DrugPatentWatch.com thinkBiotech, 2022 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.
When can LUSEDRA (fospropofol disodium) generic drug versions launch?

Generic name: fospropofol disodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 01, 2022
Generic Entry Controlled by: United States Patent Patent 6,204,257

LUSEDRA is a drug marketed by Eisai Inc. There is one patent protecting this drug.

This drug has thirty-four patent family members in twenty-five countries.

The generic ingredient in LUSEDRA is fospropofol disodium. Additional details are available on the fospropofol disodium profile page.

When can ULESFIA (benzyl alcohol) generic drug versions launch?

Generic name: benzyl alcohol
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 11, 2022
Generic Entry Controlled by: United States Patent Patent 6,793,931

ULESFIA is a drug marketed by Shionogi Inc. There are two patents protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering ULESFIA

The generic ingredient in ULESFIA is benzyl alcohol. There are fifty drug master file entries for this API. Additional details are available on the benzyl alcohol profile page.

When can GADAVIST (gadobutrol) generic drug versions launch?

Generic name: gadobutrol
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2022
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

GADAVIST is a drug marketed by Bayer Hlthcare.

See drug price trends for GADAVIST.

The generic ingredient in GADAVIST is gadobutrol. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the gadobutrol profile page.

When can IRESSA (gefitinib) generic drug versions launch?

Generic name: gefitinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2022
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

IRESSA is a drug marketed by Astrazeneca.

See drug price trends for IRESSA.

The generic ingredient in IRESSA is gefitinib. There are twelve drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the gefitinib profile page.

When can FOLOTYN (pralatrexate) generic drug versions launch?

Generic name: pralatrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 16, 2022
Generic Entry Controlled by: United States Patent Patent 6,028,071

FOLOTYN is a drug marketed by Acrotech. There are three patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has forty-four patent family members in twenty-three countries. There has been litigation on patents covering FOLOTYN

See drug price trends for FOLOTYN.

The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the pralatrexate profile page.

When can IXEMPRA KIT (ixabepilone) generic drug versions launch?

Generic name: ixabepilone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 23, 2022
Generic Entry Controlled by: United States Patent Patent 6,670,384

IXEMPRA KIT is a drug marketed by R-pharm Us Llc. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-five patent family members in thirty-five countries.

See drug price trends for IXEMPRA KIT.

The generic ingredient in IXEMPRA KIT is ixabepilone. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the ixabepilone profile page.

When can ADDYI (flibanserin) generic drug versions launch?

Generic name: flibanserin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 01, 2022
Generic Entry Controlled by: United States Patent Patent 7,420,057

ADDYI is a drug marketed by Sprout Pharms. There are four patents protecting this drug.

This drug has eighty-two patent family members in thirty-one countries.

See drug price trends for ADDYI.

The generic ingredient in ADDYI is flibanserin. One supplier is listed for this generic product. Additional details are available on the flibanserin profile page.

When can KEVEYIS (dichlorphenamide) generic drug versions launch?

Generic name: dichlorphenamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 07, 2022
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

KEVEYIS is a drug marketed by Xeris.

This drug has eighty-two patent family members in thirty-one countries.

See drug price trends for KEVEYIS.

The generic ingredient in KEVEYIS is dichlorphenamide. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dichlorphenamide profile page.

When can DULERA (formoterol fumarate; mometasone furoate) generic drug versions launch?

Generic name: formoterol fumarate; mometasone furoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 12, 2022
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

Drug Price Trends for DULERA
DULERA is a drug marketed by Organon.

This drug has eighty-two patent family members in thirty-one countries.

See drug price trends for DULERA.

The generic ingredient in DULERA is formoterol fumarate; mometasone furoate. There are nineteen drug master file entries for this API. Additional details are available on the formoterol fumarate; mometasone furoate profile page.

When can KINEVAC (sincalide) generic drug versions launch?

Generic name: sincalide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 16, 2022
Generic Entry Controlled by: United States Patent Patent 6,803,046

KINEVAC is a drug marketed by Bracco. There is one patent protecting this drug.

This drug has ten patent family members in eight countries. There has been litigation on patents covering KINEVAC

See drug price trends for KINEVAC.

The generic ingredient in KINEVAC is sincalide. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the sincalide profile page.

When can ORAVIG (miconazole) generic drug versions launch?

Generic name: miconazole
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 11, 2022
Generic Entry Controlled by: United States Patent Patent 6,916,485

ORAVIG is a drug marketed by Galt Pharms. There are three patents protecting this drug.

This drug has twenty-four patent family members in fourteen countries.

See drug price trends for ORAVIG.

The generic ingredient in ORAVIG is miconazole. There are twenty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the miconazole profile page.

When can YONDELIS (trabectedin) generic drug versions launch?

Generic name: trabectedin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 23, 2022
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

YONDELIS is a drug marketed by Janssen Prods. There is one patent protecting this drug.

This drug has forty-four patent family members in thirty-six countries. There has been litigation on patents covering YONDELIS

See drug price trends for YONDELIS.

The generic ingredient in YONDELIS is trabectedin. There are four drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the trabectedin profile page.

When can TRI-LUMA (fluocinolone acetonide; hydroquinone; tretinoin) generic drug versions launch?

Generic name: fluocinolone acetonide; hydroquinone; tretinoin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 25, 2022
Generic Entry Controlled by: United States Patent Patent 8,653,053

TRI-LUMA is a drug marketed by Galderma Labs Lp. There are four patents protecting this drug.

This drug has twenty-nine patent family members in eighteen countries.

See drug price trends for TRI-LUMA.

The generic ingredient in TRI-LUMA is fluocinolone acetonide; hydroquinone; tretinoin. There are twelve drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the fluocinolone acetonide; hydroquinone; tretinoin profile page.

When can LUMASON (sulfur hexafluoride lipid-type a microspheres) generic drug versions launch?

Generic name: sulfur hexafluoride lipid-type a microspheres
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 13, 2022
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

LUMASON is a drug marketed by Bracco. There are two patents protecting this drug.

This drug has nine patent family members in nine countries.

See drug price trends for LUMASON.

The generic ingredient in LUMASON is sulfur hexafluoride lipid-type a microspheres. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the sulfur hexafluoride lipid-type a microspheres profile page.

When can XERESE (acyclovir; hydrocortisone) generic drug versions launch?

Generic name: acyclovir; hydrocortisone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 13, 2022
Generic Entry Controlled by: United States Patent Patent 7,223,387

XERESE is a drug marketed by Bausch. There is one patent protecting this drug.

This drug has twenty-five patent family members in twenty-one countries.

See drug price trends for XERESE.

The generic ingredient in XERESE is acyclovir; hydrocortisone. There are fifty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the acyclovir; hydrocortisone profile page.

When can XOFIGO (radium ra-223 dichloride) generic drug versions launch?

Generic name: radium ra-223 dichloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 17, 2022
Generic Entry Controlled by: United States Patent Patent 6,635,234

XOFIGO is a drug marketed by Bayer Hlthcare. There is one patent protecting this drug.

This drug has thirty-four patent family members in twenty-one countries.

See drug price trends for XOFIGO.

The generic ingredient in XOFIGO is radium ra-223 dichloride. One supplier is listed for this generic product. Additional details are available on the radium ra-223 dichloride profile page.

When can GOPRELTO (cocaine hydrochloride) generic drug versions launch?

Generic name: cocaine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 14, 2022
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

GOPRELTO is a drug marketed by Genus Lifesciences. There are twelve patents protecting this drug. There has been litigation on patents covering GOPRELTO

The generic ingredient in GOPRELTO is cocaine hydrochloride. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the cocaine hydrochloride profile page.

When can GIAPREZA (angiotensin ii acetate) generic drug versions launch?

Generic name: angiotensin ii acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2022
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

GIAPREZA is a drug marketed by La Jolla Pharma. There are ten patents protecting this drug.

This drug has thirty-eight patent family members in twenty-one countries.

See drug price trends for GIAPREZA.

The generic ingredient in GIAPREZA is angiotensin ii acetate. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the angiotensin ii acetate profile page.

When can NUMBRINO (cocaine hydrochloride) generic drug versions launch?

Generic name: cocaine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 10, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

NUMBRINO is a drug marketed by Cody Labs Inc.

This drug has thirty-eight patent family members in twenty-one countries.

See drug price trends for NUMBRINO.

The generic ingredient in NUMBRINO is cocaine hydrochloride. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the cocaine hydrochloride profile page.

When can ADVIL DUAL ACTION WITH ACETAMINOPHEN (acetaminophen; ibuprofen) generic drug versions launch?

Generic name: acetaminophen; ibuprofen
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 28, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

ADVIL DUAL ACTION WITH ACETAMINOPHEN is a drug marketed by Glaxosmithkline.

This drug has thirty-eight patent family members in twenty-one countries.

The generic ingredient in ADVIL DUAL ACTION WITH ACETAMINOPHEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the acetaminophen; ibuprofen profile page.

When can NORMOCARB HF 25 (magnesium chloride; sodium bicarbonate; sodium chloride) generic drug versions launch?

Generic name: magnesium chloride; sodium bicarbonate; sodium chloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 04, 2023
Generic Entry Controlled by: United States Patent Patent 7,300,674

NORMOCARB HF 25 is a drug marketed by Dialysis Sups. There is one patent protecting this drug.

This drug has four patent family members in four countries.

The generic ingredient in NORMOCARB HF 25 is magnesium chloride; sodium bicarbonate; sodium chloride. There are one hundred and forty-six drug master file entries for this API. Additional details are available on the magnesium chloride; sodium bicarbonate; sodium chloride profile page.

When can CHLORAPREP ONE-STEP (chlorhexidine gluconate; isopropyl alcohol) generic drug versions launch?

Generic name: chlorhexidine gluconate; isopropyl alcohol
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 14, 2023
Generic Entry Controlled by: United States Patent Patent 7,241,065

CHLORAPREP ONE-STEP is a drug marketed by Becton Dickinson Co. There are two patents protecting this drug.

This drug has twelve patent family members in eleven countries.

The generic ingredient in CHLORAPREP ONE-STEP is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.

When can DEFITELIO (defibrotide sodium) generic drug versions launch?

Generic name: defibrotide sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

DEFITELIO is a drug marketed by Jazz Pharms Inc. There are two patents protecting this drug.

This drug has twenty-five patent family members in sixteen countries.

See drug price trends for DEFITELIO.

The generic ingredient in DEFITELIO is defibrotide sodium. One supplier is listed for this generic product. Additional details are available on the defibrotide sodium profile page.

When can TARGINIQ (naloxone hydrochloride; oxycodone hydrochloride) generic drug versions launch?

Generic name: naloxone hydrochloride; oxycodone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 04, 2023
Generic Entry Controlled by: United States Patent Patent 9,907,793

TARGINIQ is a drug marketed by Purdue Pharma Lp. There are fifteen patents protecting this drug.

This drug has three hundred and five patent family members in forty-four countries. There has been litigation on patents covering TARGINIQ

The generic ingredient in TARGINIQ is naloxone hydrochloride; oxycodone hydrochloride. There are twelve drug master file entries for this API. Additional details are available on the naloxone hydrochloride; oxycodone hydrochloride profile page.

When can PROVAYBLUE (methylene blue) generic drug versions launch?

Generic name: methylene blue
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 08, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

PROVAYBLUE is a drug marketed by Provepharm Sas.

This drug has three hundred and five patent family members in forty-four countries.

See drug price trends for PROVAYBLUE.

The generic ingredient in PROVAYBLUE is methylene blue. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the methylene blue profile page.

When can AMTURNIDE (aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide) generic drug versions launch?

Generic name: aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 16, 2023
Generic Entry Controlled by: United States Patent Patent 8,183,295

AMTURNIDE is a drug marketed by Novartis. There is one patent protecting this drug.

This drug has thirty-two patent family members in twenty-four countries.

The generic ingredient in AMTURNIDE is aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide. There are four drug master file entries for this API. Additional details are available on the aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide profile page.

When can LUCEMYRA (lofexidine hydrochloride) generic drug versions launch?

Generic name: lofexidine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 16, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

Drug Price Trends for LUCEMYRA
LUCEMYRA is a drug marketed by Uswm.

This drug has thirty-two patent family members in twenty-four countries.

See drug price trends for LUCEMYRA.

The generic ingredient in LUCEMYRA is lofexidine hydrochloride. Additional details are available on the lofexidine hydrochloride profile page.

When can PHEXXI (citric acid; lactic acid; potassium bitartrate) generic drug versions launch?

Generic name: citric acid; lactic acid; potassium bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 22, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

Drug Price Trends for PHEXXI
PHEXXI is a drug marketed by Evofem Inc. There are two patents protecting this drug.

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

See drug price trends for PHEXXI.

The generic ingredient in PHEXXI is citric acid; lactic acid; potassium bitartrate. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the citric acid; lactic acid; potassium bitartrate profile page.

When can VISTOGARD (uridine triacetate) generic drug versions launch?

Generic name: uridine triacetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2023
Generic Entry Controlled by: United States Patent Patent 6,258,795

VISTOGARD is a drug marketed by Wellstat Therap. There are two patents protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the uridine triacetate profile page.

When can XURIDEN (uridine triacetate) generic drug versions launch?

Generic name: uridine triacetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2023
Generic Entry Controlled by: United States Patent Patent 6,258,795

XURIDEN is a drug marketed by Wellstat Therap. There is one patent protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in XURIDEN is uridine triacetate. There are thirty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the uridine triacetate profile page.

When can PHOTREXA (riboflavin 5'-phosphate sodium) generic drug versions launch?

Generic name: riboflavin 5'-phosphate sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 15, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

PHOTREXA is a drug marketed by Glaukos.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in PHOTREXA is riboflavin 5'-phosphate sodium. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the riboflavin 5'-phosphate sodium profile page.

When can MOZOBIL (plerixafor) generic drug versions launch?

Generic name: plerixafor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 22, 2023
Generic Entry Controlled by: United States Patent Patent 7,897,590

MOZOBIL is a drug marketed by Genzyme. There are two patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in twenty-seven countries. There has been litigation on patents covering MOZOBIL

See drug price trends for MOZOBIL.

The generic ingredient in MOZOBIL is plerixafor. There are seven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the plerixafor profile page.

When can BREZTRI AEROSPHERE (budesonide; formoterol fumarate; glycopyrrolate) generic drug versions launch?

Generic name: budesonide; formoterol fumarate; glycopyrrolate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 23, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

BREZTRI AEROSPHERE is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug.

This drug has one hundred and seventy-three patent family members in thirty-one countries.

The generic ingredient in BREZTRI AEROSPHERE is budesonide; formoterol fumarate; glycopyrrolate. There are twenty-two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the budesonide; formoterol fumarate; glycopyrrolate profile page.

When can CYSTADROPS (cysteamine hydrochloride) generic drug versions launch?

Generic name: cysteamine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 19, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

CYSTADROPS is a drug marketed by Recordati Rare.

This drug has one hundred and seventy-three patent family members in thirty-one countries.

See drug price trends for CYSTADROPS.

The generic ingredient in CYSTADROPS is cysteamine hydrochloride. There are six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the cysteamine hydrochloride profile page.

When can VYVANSE (lisdexamfetamine dimesylate) generic drug versions launch?

Generic name: lisdexamfetamine dimesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 24, 2023
Generic Entry Controlled by: United States Patent Patent 7,655,630

Drug Price Trends for VYVANSE
VYVANSE is a drug marketed by Takeda Pharms Usa. There are nineteen patents protecting this drug and one Paragraph IV challenge. Five tentatively approved generics are ready to enter the market.

This drug has one hundred and forty-eight patent family members in twenty-seven countries. There has been litigation on patents covering VYVANSE

See drug price trends for VYVANSE.

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. One supplier is listed for this generic product. Additional details are available on the lisdexamfetamine dimesylate profile page.

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