Alvogen

Alvogen

NJ - Morristown
Biotechnology1 H-1B visas (FY2023)

Focus: Generics, OTCs

Alvogen is a life sciences company focused on Generics, OTCs.

OncologyHematologyImmunologyEndocrinologyCardiovascular
Funding Stage
PUBLIC
Open Jobs
9

Products & Portfolio (16)

34 discontinued products not shown

ACETYLCYSTEINE
acetylcysteine
Post-LOE
INHALATION, ORAL · SOLUTION
Reduction Activity
asthma
2014
45
ACETYLCYSTEINE
acetylcysteine
Post-LOE
INHALATION, ORAL · SOLUTION
Reduction Activity
asthma
2012
45
BONSITY
teriparatide
Peak
SUBCUTANEOUS · SOLUTION
84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and teriparatide are mediated through binding to specific high-affinity cell-surface receptors. Teriparatide and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney. Teriparatide is not expected to accumulate in bone or other tissues. The skeletal effects of teriparatide depend upon the pattern of systemic exposure. Once-daily administration of teriparatide stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. In monkey studies, teriparatide improved trabecular microarchitecture and increased bone mass and strength by stimulating new bone formation in both cancellous and cortical bone. In humans, the anabolic effects of teriparatide manifest as an increase in skeletal mass, an increase in markers of bone formation and resorption, and an increase in bone strength. By contrast, continuous excess of endogenous PTH, as occurs in hyperparathyroidism, may be detrimental to the skeleton because bone resorption may be stimulated more than bone formation.
women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mggreater of prednisone) at high risk for fractureosteoporosis+1 more
2019
30
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
buprenorphine and naloxone
Post-LOE
BUCCAL, SUBLINGUAL · FILM
naloxone. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is a potent antagonist at mu-opioid receptors and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.
opioid dependence
2019
30
DEXAMETHASONE
dexamethasone
Post-LOE
ORAL · TABLET
Corticosteroid Hormone Receptor Agonists
dermatomyositispolymyositissystemic lupus erythematosus+8 more
1983
60
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets, 5 mg,cll
Post-LOE
ORAL · TABLET
CLINICAL PHARMACOLOGY Pharmacodynamics Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Pharmacokinetics Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 mg or 30 mg of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l-amphetamine. The mean elimination half-life (t 1/2 ) for d-amphetamine was shorter than the t 1/2 of the l-isomer (9.77 to 11 hours vs. 11.5 to 13.8 hours). The PK parameters (C max , AUC 0-inf ) of d- and l-amphetamine increased approximately three-fold from 10 mg to 30 mg indicating dose-proportional pharmacokinetics. The effect of food on the bioavailability of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets has not been studied. Metabolism and Excretion Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4-hydroxyamphetamine, or on the side chain α or β carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid. Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility. Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated. In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However, due to the probability of auto-inhibition and the lack of information on the concentration of these metabolites relative to in vivo concentrations, no predications regarding the potential for amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes in vivo can be made. With normal urine pHs approximately half of an administered dose of amphetamine is recoverable in urine as derivatives of alpha-
Attention Deficit Hyperactivity Disorder (ADHD)Narcolepsy
2017
30
DISULFIRAM
disulfiram
Post-LOE
ORAL · TABLET
Acetyl Aldehyde Dehydrogenase Inhibitors
2013
30
HYDROCODONE BITARTRATE
hydrocodone bitartrate
Post-LOE
ORAL · TABLET, EXTENDED RELEASE
mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
severepersistent painfor which alternative treatment options are inadequate
2021
45
HYDROCODONE BITARTRATE
hydrocodone bitartrate
Post-LOE
ORAL · CAPSULE, EXTENDED RELEASE
mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
severepersistent painfor which alternative treatment options are inadequate
2020
45
IBRUTINIB
ibrutinib
Pre-Launch
SMORAL · CAPSULE
IBRUTINIB
ibrutinib
Pre-Launch
SMORAL · TABLET
LENALIDOMIDE
lenalidomide
Post-LOE
ORAL · CAPSULE
immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of lenalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. In vitro, in the presence of drug, substrate proteins (including Aiolos, Ikaros, and CK1α) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects. Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including MM and del (5q) myelodysplastic syndromes in vitro . Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including MM. Immunomodulatory properties of lenalidomide include increased number and activation of T cells and natural killer (NK) cells leading to direct and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) via increased secretion of interleukin-2 and interferon-gamma, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. In MM cells, the combination of lenalidomide and dexamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis.
intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality withwithout additional cytogenetic abnormalities
2022
30
View all 16 products

Pipeline & Clinical Trials

Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effe
HIV Infections
N/A
Anplag
Healthy
Phase 1
Clinical Trials (1)
NCT01429688Pharmacokinetic / Pharmacodynamic (PK/PD) Study of Multiple Doses of DP-R202 in Healthy Volunteers
Phase 1
DP-R208
Healthy
Phase 1
Clinical Trials (1)
NCT02707224Clinical Trial to Compare the Pharmacokinetics of DP-R208
Phase 1
Anplag
Healthy
Phase 1
Clinical Trials (1)
NCT01421563Safety and Pharmacokinetic Characteristics of DP-R202 in Healthy Male Volunteers
Phase 1
bonviva
Healthy
Phase 1
Clinical Trials (1)
NCT01429675Safety and Pharmacokinetic Characteristics of DP-R206 in Healthy Adult Volunteers
Phase 1
DP-R213
Healthy
Phase 1
Clinical Trials (1)
NCT03010267DP-R213 Phase 1 Pharmacokinetics Study
Phase 1
AK-R215
Healthy
Phase 1
Clinical Trials (1)
NCT03321318AK-R215 Pharmacokinetic Study Phase I
Phase 1
Cholecalciferol
Healthy
Phase 1
Clinical Trials (1)
NCT02654093A Drug-drug Interaction Study of DP-R213
Phase 1
Amlodipine
Hypertension
Phase 1
Clinical Trials (1)
NCT02789475DP-R212 Pharmacokinetic Study
Phase 1
Treatment B
Healthy
Phase 1
Clinical Trials (1)
NCT03005340A Phase 1 Drug Drug Interaction Clinical Trial of C1-R215 and C2-R215 in Healthy Male Volunteers
Phase 1
DP-R213
Healthy
Phase 1
Clinical Trials (1)
NCT02762643DP-R213 Pharmacokinetics Study
Phase 1
DP-R212
Healthy
Phase 1
Clinical Trials (1)
NCT02814500DP-R212 Pharmacokinetic Study Phase I
Phase 1
Candesartan
Healthy
Phase 1
Clinical Trials (1)
NCT02079506Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin
Phase 1
High fat meal
Healthy
Phase 1
Clinical Trials (1)
NCT01421576Bioavailability Study of DP-R202 in Healthy Male Volunteers Under Fed Conditions
Phase 1
Vitamin D3
Healthy
Phase 1
Clinical Trials (1)
NCT01577849Safety and Pharmacokinetic Characteristics of DP-R206(Vitamin D3) in Healthy Adult Volunteers
Phase 1
Phase 1
Clinical Trials (1)
NCT02730689A Study to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone
Phase 1
DP-R208
Healthy
Phase 1
Clinical Trials (1)
NCT02709187DP-R208 Pharmacokinetic Study
Phase 1
Phase 3
Clinical Trials (1)
NCT02955368Clinical Trial to Evaluate the Efficacy and Safety of DP-R212
Phase 3
Clinical Trials (1)
NCT01581320Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis
Phase 3
Phase 3
Clinical Trials (1)
NCT02995694A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
Phase 3
Phase 3
Clinical Trials (1)
NCT02445352Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia
Phase 3
Phase 3
Clinical Trials (1)
NCT02770261Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy
Phase 3
Clinical Trials (1)
NCT02393612Clinical Trial to Evaluate Efficacy and Safety of DP-R202 and Anplag in Patients With Artery Occlusive Disease
Phase 3
Phase 4
Clinical Trials (1)
NCT02718846Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets
Phase 4
Qsymia 3.75Mg-23Mg Extended Release Capsule
Obesity
Phase 4
Clinical Trials (1)
NCT05378503Phase IV Study of Qsymia in Obese Patients
Phase 4

Open Jobs (9)

Interview Prep Quick Facts
Founded: 2024
Portfolio: 57 approved products, 24 clinical trials
Top TAs: Cardiovascular, Endocrinology, Hematology
H-1B (2023): 1 approval
Open Roles: 9 active jobs
Portfolio Health
Pre-Launch2 (4%)
Peak1 (2%)
LOE Approaching10 (18%)
Post-LOE44 (77%)
57 total products
Therapeutic Area Focus
Cardiovascular
3 pipeline
Endocrinology
2 marketed
Hematology
2 marketed
Oncology
2 marketed
Respiratory
2 marketed
Neurology
1 marketed
Psychiatry
1 marketed
Immunology
1 marketed
Marketed
Pipeline

Hiring Trend

Stable
9
Open Roles
+1
Added
-0
Filled/Removed

Based on last 4 crawl cycles

Visa Sponsorship

Sponsors Work Visas
H-1B Petitions (FY2023)
1
Approved
0
Denied
100%
Rate

Source: USCIS H-1B Employer Data Hub