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INULIN AND SODIUM CHLORIDE

NDA

INULIN | N002282 | ISO TEX DIAGNOSTICS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from General Mills, Inc. FDA-2016-P-2863 · 86 docket documents General Mills, Inc., filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA amend 21 C.F.R. § 101.9(c)(6)(i) to include inulin-type fructans extracted from chicory root in the regulatory definition of dietary fiber, citing scientific evidence that chicory root extract improves l	Other	2016-10-04	Granted	General Mills, Inc.
Citizen Petition from General Mills, Inc. FDA-2016-P-2860 · 5 docket documents General Mills, Inc. filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA extend the compliance timeline for the revised dietary fiber definition in 21 C.F.R. § 101.9(c)(6)(i) until three years after the agency determines whether inulin-type fructans extracted from chicory root	Other	2016-10-04	Granted	General Mills, Inc.
Citizen Petition from Hyman, Phelps & McNamara, P.C. (Beneo, Cosucra Groupe W... FDA-2016-P-2736 · 76 docket documents Law firm Hyman, Phelps & McNamara, P.C., on behalf of Beneo, Cosucra Groupe Warcoing S.A., and Sensus B.V., filed this citizen petition requesting that the FDA amend 21 C.F.R. § 101.9(c)(6)(i) to recognize inulin-type fructans derived from chicory root as dietary fiber for purposes of nutrition labe	Other	2016-09-15	Granted	Hyman, Phelps & McNamara, P.C. (Beneo, Cosucra Groupe Warcoing S.A., and Sensus B.V.)

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

83 trials from ClinicalTrials.gov — 1 recruiting, 71 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Correlation and Intervention of Intestinal Flora and Frailty in the Elderly NCT03995342	N/A	By Invitation	Xijing Hospital	300	2019-08-01 → 2024-12-31
Modification of Gut Microbiota in the Treatment of Insulin Resistance: a Personalized Approach NCT03710850	N/A	Completed	Charles University, Czech Republic	28	2018-05-01 → 2021-03-30
Inulin and S. Salivarius Reduce Halitosis NCT02794766	Phase 2	Completed	Universidade de Passo Fundo	45	2014-03 → 2015-11
Prebiotics in Patients With Non-alcoholic Liver Disease NCT02642172	N/A	Completed	Kaplan Medical Center	24	2016-01 → 2023-03-20
Partial Meal Replacement and Inulin in Obese Women NCT01505023	Phase 2	Completed	Cindetec	179	2006-04 → 2007-02
Effect of Fermentable Carbohydrate on Glucose Homeostasis NCT01841073	N/A	Completed	Imperial College London	44	2011-03 → 2014-08
Combination of Metformin/Inulin vs Inulin on Adiponectin in Metabolic Syndrome NCT02773927	Phase 3	Completed	Centro Universitario de Ciencias de la Salud, Mexico	40	2013-01 → 2015-06
Effect of Fibre Products on Appetite and Weight NCT00750438	N/A	Completed	Imperial College London	60	2008-09 → 2012-10
Assessment of Renal Physiology by Magnetic Resonance Imaging (MRI) in Normal Volunteers NCT00936416	N/A	Completed	University Health Network, Toronto	24	2010-01 → 2011-12
Investigating Optimal Propionate Delivery to the Colon Using Stable Isotope Labeling NCT02229500	N/A	Completed	Scottish Universities Environmental Research Centre	10	2014-08 → 2015-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

PFANSTIEHL LABORATORIES INCInactiveINULIN, USP

DMF 127131997

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 100MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.