Company profile for BRAINTREE LABS

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About

Braintree Laboratories is a privately held pharmaceutical company that was founded in 1982 in Braintree, Massachusetts. Braintree currently has 4 gastrointestinal lavages available in the US market. Braintree Laboratories pioneered the first gastrointestinal lavage in 1984 with the introduction of GoLYTELY® (PEG-3350 and electrolytes for oral solution). GoLYTELY is indicated for bowel cleansing prior to colonoscopy and bariu...
Braintree Laboratories is a privately held pharmaceutical company that was founded in 1982 in Braintree, Massachusetts. Braintree currently has 4 gastrointestinal lavages available in the US market. Braintree Laboratories pioneered the first gastrointestinal lavage in 1984 with the introduction of GoLYTELY® (PEG-3350 and electrolytes for oral solution). GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema x-ray examination. GoLYTELY was the first to market with this innovative bowel prep technology and was soon adopted as a standard prepping procedure. The 1990's ushered in a new generation of gastrointestinal lavages. NuLYTELY® (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution), a reformulation of the original GoLYTELY, provided patients with an improved taste and a 52% less sodium alternative to the other lavages on the market. NuLYTELY is available with flavor packs in cherry, lemon-lime, orange and pineapple.

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CONTACT DETAILS

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Country
Country
U.S.A
Address
Address
Braintree Laboratories Inc. 60 Columbian Street West PO Box 850929 Braintree, ...
Telephone
Telephone
(800) 874-6756
Linkedin
Linkedin
youtube
YouTube
Twitter
Twitter

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Events

Webinars & Exhibitions

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NEWS #PharmaBuzz

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https://www.prnewswire.com/news-releases/sebela-pharmaceuticals-presents-phase-3-tegoprazan-data-in-erosive-esophagitis-at-digestive-disease-week-ddw-2026-302762622.html

PR NEWSWIRE
05 May 2026

https://www.prnewswire.com/news-releases/sebela-pharmaceuticals-announces-positive-topline-results-from-phase-3-triumph-program-of-tegoprazan-in-gerd-302435337.html

PR NEWSWIRE
23 Apr 2025

https://www.globenewswire.com/news-release/2025/02/04/3020323/0/en/Microbot-Medical-Announces-Late-Breaking-Abstract-Acceptance-at-the-Society-of-Interventional-Radiology-Annual-Meeting.html

GLOBENEWSWIRE
04 Feb 2025

https://www.globenewswire.com/news-release/2024/12/30/3002679/0/en/Microbot-Medical-Concludes-2024-by-Achieving-Key-Milestones-Culminating-in-FDA-Submission-for-the-Commercialization-of-LIBERTY.html

GLOBENEWSWIRE
30 Dec 2024

http://www.patentdocs.org/2017/05/braintree-laboratories-inc-v-breckenridge-pharmaceutical-inc-fed-cir-2017.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+PatentDocs+%28Patent+Docs%29

PRESS RELEASE
05 May 2017

01

Tegoprazan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Tegoprazan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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Drugs in Development

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Details:

K-CAB (tegoprazan) is a potassium-competitive acid blocker (P-CAB), a new-generation acid suppressant. It is indicated for the treatment of gastroesophageal reflux disease.


Lead Product(s): Tegoprazan

Therapeutic Area: Gastroenterology Brand Name: K-CAB

Study Phase: Approved FDFProduct Type: Miscellaneous

Recipient: HK inno.N

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 08, 2025

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PEGS Boston Summit
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PEGS Boston Summit
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Details : K-CAB (tegoprazan) is a potassium-competitive acid blocker (P-CAB), a new-generation acid suppressant. It is indicated for the treatment of gastroesophageal reflux disease.

Product Name : K-CAB

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 08, 2025

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Details:

K-CAB (tegoprazan) is a potassium-competitive acid blocker (P-CAB), a new-generation acid suppressant. It is indicated for the treatment of gastroesophageal reflux disease.


Lead Product(s): Tegoprazan

Therapeutic Area: Gastroenterology Brand Name: K-CAB

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 07, 2025

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
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Details : K-CAB (tegoprazan) is a potassium-competitive acid blocker (P-CAB), a new-generation acid suppressant. It is indicated for the treatment of gastroesophageal reflux disease.

Product Name : K-CAB

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 07, 2025

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Details:

BLI5100 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Non-Erosive Reflux Disease.


Lead Product(s): BLI5100

Therapeutic Area: Gastroenterology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 05, 2023

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03

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
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Details : BLI5100 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Non-Erosive Reflux Disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 05, 2023

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Details:

BLI5100 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Non-Erosive Reflux Disease.


Lead Product(s): BLI5100

Therapeutic Area: Gastroenterology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 20, 2022

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04

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : BLI5100 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Non-Erosive Reflux Disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 20, 2022

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Details:

BLI5100 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Esophagitis.


Lead Product(s): BLI5100

Therapeutic Area: Gastroenterology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 20, 2022

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05

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : BLI5100 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Esophagitis.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 20, 2022

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Details:

K-CAB (tegoprazan) is a potassium-competitive acid blocker (P-CAB), a new-generation acid suppressant. It is indicated for the treatment of gastroesophageal reflux disease.


Lead Product(s): Tegoprazan

Therapeutic Area: Gastroenterology Brand Name: K-CAB

Study Phase: Approved FDFProduct Type: Miscellaneous

Recipient: HK inno.N

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 20, 2022

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06

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : K-CAB (tegoprazan) is a potassium-competitive acid blocker (P-CAB), a new-generation acid suppressant. It is indicated for the treatment of gastroesophageal reflux disease.

Product Name : K-CAB

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 20, 2022

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Details:

Tegoprazan (CJ-12420) is a novel agent in development for the treatment of acid-related gastrointestinal diseases. Tegoprazan has already received marketing authorization in multiple territories, including South Korea and China.


Lead Product(s): Tegoprazan

Therapeutic Area: Gastroenterology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Sebela Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition October 19, 2022

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07

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Tegoprazan (CJ-12420) is a novel agent in development for the treatment of acid-related gastrointestinal diseases. Tegoprazan has already received marketing authorization in multiple territories, including South Korea and China.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

October 19, 2022

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Details:

This drug candidate is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.


Lead Product(s): Undisclosed

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Undisclosed

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 24, 2020

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08

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Lead Product(s) : Undisclosed

Therapeutic Area : Undisclosed

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : This drug candidate is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Undisclosed

Upfront Cash : Inapplicable

June 24, 2020

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Details:

This drug candidate is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.


Lead Product(s): Undisclosed

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Undisclosed

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 24, 2020

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09

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Lead Product(s) : Undisclosed

Therapeutic Area : Undisclosed

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : This drug candidate is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Undisclosed

Upfront Cash : Inapplicable

June 24, 2020

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Details:

BLI800 is a drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.


Lead Product(s): BLI800

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Undisclosed

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 02, 2020

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10

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : BLI800 is a drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Undisclosed

Upfront Cash : Inapplicable

January 02, 2020

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FDF Dossiers

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01

Brand Name : HALFLYTELY

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Brand Name : HALFLYTELY

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BRAINTREE LABS

Dosage Form : FOR SOLUTION, TABLET, DE...

Brand Name : HALFLYTELY

Dosage Strength : 5MG,N/A;N/A,210GM;N/A,...

Packaging :

Approval Date :

Application Number : 21551

Regulatory Info :

Registration Country : USA

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02

Brand Name : HALFLYTELY

PEGS Boston Summit
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Brand Name : HALFLYTELY

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PEGS Boston Summit
Not Confirmed

BRAINTREE LABS

Dosage Form : FOR SOLUTION, TABLET, DE...

Brand Name : HALFLYTELY

Dosage Strength : 5MG,N/A;N/A,210GM;N/A,...

Packaging :

Approval Date : 2010-07-16

Application Number : 21551

Regulatory Info : DISCN

Registration Country : USA

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03

Brand Name : PIZENSY

PEGS Boston Summit
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Brand Name : PIZENSY

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PEGS Boston Summit
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BRAINTREE LABS

Dosage Form : FOR SOLUTION;ORAL

Brand Name : PIZENSY

Dosage Strength : 10GM

Packaging :

Approval Date : 2020-02-12

Application Number : 211281

Regulatory Info : DISCN

Registration Country : USA

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Brand Name : PIZENSY

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Brand Name : PIZENSY

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PEGS Boston Summit
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BRAINTREE LABS

Dosage Form : SOLUTION;ORAL

Brand Name : PIZENSY

Dosage Strength : 20G

Packaging :

Approval Date :

Application Number : 211281

Regulatory Info :

Registration Country : USA

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Brand Name : SUCLEAR

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Brand Name : SUCLEAR

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BRAINTREE LABS

Dosage Form : SOLUTION;ORAL

Brand Name : SUCLEAR

Dosage Strength : 1.6GM/BOT,3.13GM/BOT,1...

Packaging :

Approval Date : 2013-01-18

Application Number : 203595

Regulatory Info : DISCN

Registration Country : USA

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06

Brand Name : AXID

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Brand Name : AXID

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PEGS Boston Summit
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BRAINTREE LABS

Dosage Form : SOLUTION;ORAL

Brand Name : AXID

Dosage Strength : 15MG/ML **Federal Regi...

Packaging :

Approval Date : 2004-05-25

Application Number : 21494

Regulatory Info : DISCN

Registration Country : USA

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07

Brand Name : MIRALAX

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Brand Name : MIRALAX

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BRAINTREE LABS

Dosage Form : FOR SOLUTION; ORAL

Brand Name : MIRALAX

Dosage Strength : 17GM/SCOOPFUL

Packaging :

Approval Date :

Application Number : 20698

Regulatory Info :

Registration Country : USA

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FDA Orange Book

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Inspections and registrations

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ABOUT THIS PAGE

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BRAINTREE LABS is a supplier offers 1 products (APIs, Excipients or Intermediates).

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