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Amino Acids Patent Expiration

Amino Acids was first introduced by B Braun Medical Inc in its drug Freamine 8.5% on Approved Prior to Jan 1, 1982. Other drugs containing Amino Acids are Travasol 5.5% W/O Electrolytes, Branchamin 4%, Aminosyn Ii 10% In Plastic Container, Nephramine 5.4%, Aminosyn 10% (Ph6), Aminosyn 8.5%, Freamine Iii 10%, Travasol 10% In Plastic Container, Freamine Ii 8.5%, Novamine 11.4%, Travasol 10% W/O Electrolytes, Aminosyn-Rf 5.2%, Aminosyn Ii 7%, Novamine 8.5%, Aminosyn 3.5% In Plastic Container, Aminess 5.2% Essential Amino Acids W/ Histadine, Freamine Iii 8.5%, Aminosyn 10%, Trophamine 10%, Aminosyn-Pf 7%, Aminosyn Ii 5%, Trophamine, Aminosyn-Pf 10%, Freamine Hbc 6.9%, Aminosyn Ii 15% In Plastic Container, Aminosyn 8.5% (Ph6), Aminosyn-Hbc 7% In Plastic Container, Aminosyn Ii 10%, Aminosyn Ii 3.5% In Plastic Container, Aminosyn Ii 8.5%, Novamine 15% Sulfite Free In Plastic Container, Hepatamine 8%, Branchamin 4% In Plastic Container, Travasol 8.5% In Plastic Container, Travasol 5.5% In Plastic Container, Aminosyn 7% (Ph6), Aminosyn-Hbc 7%, Renamin W/O Electrolytes, Aminosyn 3.5%, Aminosyn 7%, Prosol 20% Sulfite Free In Plastic Container, Aminosyn 5%, Neopham 6.4%, Novamine 15%, Aminosyn Ii 3.5%, Travasol 8.5% W/O Electrolytes. 7 different companies have introduced drugs containing Amino Acids.


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Clinical Trials

Recent Clinical Trials on Amino Acids:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Immunotherapy Targeting of Cytomegalovirus Antigens in Glioblastoma Charlotte Lemech NA RECRUITING
(Sep 1, 2026)
PHASE1
BCAAs in Concussion 2.0 Akiva Cohen NA COMPLETED
(Sep 1, 2026)
PHASE2
Phase I/II Trial of Electroporation-Delivered pBI-4 Vaccine (TriGrid™ PVX4) for Treatment of Women With HPV16-Positive CIN1 or Persistent Infection Chang Gung Memorial Hospital NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Study of SGN1 in Patients With Advanced Solid Tumor Guangzhou Sinogen Pharmaceutical Co., Ltd NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor Guangzhou Sinogen Pharmaceutical Co., Ltd NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation Sawa Ito, MD NA RECRUITING
(Aug 1, 2026)
PHASE2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis The University of Texas Health Science Center at San Antonio NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma Joshua Palmer NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy Patients Matthew Spector NA RECRUITING
(Aug 1, 2026)
PHASE2
Study of LNP.UCD.ABE in Patients With Urea Cycle Disorders Rebecca Ahrens-Nicklas NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
BCAAs in Concussion 3.0 Akiva Cohen NA RECRUITING
(Aug 1, 2026)
PHASE2
Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer: A Randomized Controlled Trial West China Hospital NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Bridging Study of XKH001 in Healthy Adult Caucasian Participants Zhejiang Kanova Biopharmaceutical Co., LTD NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Evaluate the Efficacy and Safety of Irochel for the Management of Iron Overload in Thalassemia Patients in Comparison With Deferoxamine Hamdard University NA COMPLETED
(Aug 1, 2026)
PHASE3
Diagnosis of Pheochromocytoma Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) NA RECRUITING
(Jul 29, 2026)
PHASE1
Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine National Institute of Allergy and Infectious Diseases (NIAID) NA COMPLETED
(Jul 1, 2026)
PHASE1, PHASE2
First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuria Otsuka Pharmaceutical Development & Commercialization, Inc. NA COMPLETED
(Jul 1, 2026)
PHASE1, PHASE2
A Study to Assess the Safety and Effectiveness of Two Experimental Malaria Vaccines University of Oxford NA COMPLETED
(Jul 1, 2026)
PHASE1, PHASE2
A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women. Graminex LLC NA RECRUITING
(Jul 1, 2026)
PHASE2
Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy Dana Fuhrman NA RECRUITING
(Jul 1, 2026)
PHASE2
INCREmental DIalysis and Diet for a Better Life Experience Centre Hospitalier le Mans NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO Centre Hospitalier Universitaire de Nice NA COMPLETED
(Jun 1, 2026)
PHASE3
A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults ANRS, Emerging Infectious Diseases NA COMPLETED
(Jun 1, 2026)
PHASE1
A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer University of Southampton NA TERMINATED
(Jun 1, 2026)
PHASE2
A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus) George Washington University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Progesterone and Muscle Protein Synthesis in Premenopausal Women (MP4-MPS) McMaster University NA COMPLETED
(Jun 1, 2026)
PHASE1
Evaluating the Safety and Efficacy of PNMR as Treatment for Long COVID ParagonClinicals Inc. NA RECRUITING
(Jun 1, 2026)
PHASE2
Phase II 177Lu-DOTATATE Study in Metastatic NPC With a Safety Run-in National Cancer Centre, Singapore NA SUSPENDED
(May 1, 2026)
PHASE2
Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors Perspective Therapeutics NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Fecal Microbiota Transplantation for IBS Madhusudan (Madhu) Grover, MBBS NA RECRUITING
(May 1, 2026)
PHASE2
A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis Genexine, Inc. NA RECRUITING
(May 1, 2026)
PHASE3
Alternative RUTFs for Treatment of Child Wasting International Food Policy Research Institute NA COMPLETED
(May 1, 2026)
PHASE3
SMART Diets for MASLD Michigan State University NA RECRUITING
(May 1, 2026)
PHASE2
PROGAIN Trial in Gastric Cancer Surgery Soonchunhyang University Hospital NA RECRUITING
(May 1, 2026)
PHASE3
Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors West China Hospital NA RECRUITING
(May 1, 2026)
PHASE1
Phase I Study of 131-I mIBG Followed by Nivolumab & Dinutuximab Beta Antibodies in Children With Relapsed/Refractory Neuroblastoma University Hospital Southampton NHS Foundation Trust NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa National Institute of Allergy and Infectious Diseases (NIAID) NA COMPLETED
(Apr 1, 2026)
PHASE2, PHASE3
Prospective Clinical Trial of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer First Affiliated Hospital of Fujian Medical University NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Vosoritide for Selected Genetic Causes of Short Stature Andrew Dauber NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer Imugene Limited NA TERMINATED
(Mar 1, 2026)
PHASE1
Application of Al18F-octreotide PET/CT in Tumors With Positive SSTR Expression Cancer Institute and Hospital, Chinese Academy of Medical Sciences NA RECRUITING
(Mar 1, 2026)
PHASE2, PHASE3
Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study University of Alberta NA RECRUITING
(Mar 1, 2026)
PHASE1


Amino Acids Generic API Manufacturers

Several generic applications have been filed for Amino Acids. The first generic version for Amino Acids was by Icu Medical Inc and was approved on Apr 4, 1996. And the latest generic version is by B Braun Medical Inc and was approved on Apr 13, 2012.

Given below is the list of companies who have filed for Amino Acids generic, along with the locations of their manufacturing plants worldwide.