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FREAMINE 8.5%

NDA

AMINO ACIDS | N016822 | B BRAUN MEDICAL INC

7 strengths0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

63 trials from ClinicalTrials.gov — 35 recruiting, 20 active, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy NCT03055013	Phase 3	Active	National Cancer Institute (NCI)	819	2017-04-28 → 2031-06-09
A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles NCT02019004	Early Phase 1	Active	Northwestern University	20	2013-11 → 2027-12
Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer NCT01937117	Phase 2	Active	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	88	2014-01-30 → 2027-06
Phase 2 Trial of Ipilimumab and Nivolumab in Nasopharyngeal Carcinoma NCT03097939	Phase 2	Active	National Cancer Centre, Singapore	113	2017-03-31 → 2027-04-05
Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery NCT02506153	Phase 3	Active	National Cancer Institute (NCI)	1,301	2015-11-10 → 2027-01-23
Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery NCT01468896	Phase 1/2	Active	National Cancer Institute (NCI)	23	2011-10-26 → 2027-03-31
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions NCT05949684	Phase 3	Active	Bristol-Myers Squibb	402	2023-10-24 → 2031-05-30
A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE NCT06040099	Phase 2	Active	AstraZeneca	58	2024-02-13 → 2026-07-01
A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis NCT04123795	Phase 3	Active	UCB Biopharma SRL	49	2020-01-21 → 2026-07-02
Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A NCT03932201	—	Active	Bayer	371	2019-10-21 → 2027-03-31

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

API Supply Chain4 active DMFs4 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

KYOWA HAKKO BIO CO LTDAMINO ACIDS

DMF 31311978

KYOWA HAKKO BIO CO LTDAMINO ACIDS

DMF 31491978

AJINOMOTO HEALTH AND NUTRITION NORTH AMERICA INCAMINO ACIDS

DMF 45551982

SHANGHAI PLUMINO AMINO ACID CO LTDAMINO ACIDS

DMF 320882017

BOOTS FLINT INC SUB BOOTS CO USA INCInactiveAMINO ACIDS

DMF 281946

KYOWA HAKKO KOGYO CO LTDInactiveAMINO ACIDS

DMF 26311976

SIGMA F AND D DIV LTDInactiveAMINO ACIDS & THEIR SODIUM SALT DERIVATIVES RELATIVE TO HFN-130 INDs

DMF 26611976

NIPPON RIKAGAKUYAKUHIN CO LTDInactiveAMINO ACIDS

DMF 58961985

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 1, 2004	SUPPL -65	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — 8.5% (8.5GM/100ML)

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#006 — 6.9% (6.9GM/100ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 17, 1983

#002 — 8.5% (8.5GM/100ML)

0 patents0 exclusivities▾

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

#005 — 10% (10GM/100ML)

0 patents0 exclusivities▾

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

#003 — 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML

0 patents0 exclusivities▾

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

#004 — 8.5% (8.5GM/100ML)

0 patents0 exclusivities▾

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

#007 — 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 1, 1988