RESEARCH & DEVELOPMENT PRODUCTS

Pipeline Products - Q1 2026

API NameProprietary NameMain Indication/ TreatmentRoute, Dosage Form R&DUS DMFNCE
AbaloparatideTymlos OsteoporosisInjectable: Solution (subcutaneous)xExpired
AfamelanotideScenesseErythropoietic protoporphyria (EPP)Implant (subcutaneous)xExpired
AlprostadilMuseErectile dysfunctionUrethral: Suppositoryx-
Angiotensin IIGiaprezaTo increase blood pressureInjectable: IV Solution in single-dose vialsxExpired
AnidulafunginEraxisCandidiasisInjectable: Lyophilized Powderx-
Aripiprazole Lauroxil Aristada, Aristada Initio KitAntipsychotic (schizophrenia)Injectable: ER IM Susp. (in kit: prefilled syringes)xExpired
Aripiprazole MonohydrateAbilify Maintena, Abilify AsimtufIIAntipsychotic Schizofrenia and Bipolar DisorderInjectable: ER IM Susp.Lyophilized Powder for ER Suspension, IMx-
Baricitinib OlumiantRheumatoid arthritis, COVID-19 and alopecia areataOral: TabletsxExpired
BenzgalantamineZunveylDementia of the Alzheimer’s typeOral: DR TabletsxN/A
Berdazimer SodiumZelsuvmiMolluscum contagiosum Topical: Gelx1/5/29
BrexanoloneZurzuvae Post-Partum DepressionOral: CapsulesxExpired
Bupivacaine BaseExparel, Posimir AnestheticInjectable: Liposomal Susp.
Infiltration: Solution
x-
Bupivacaine HClMarcaine HCl, XaracollAnestheticInjectable: Solution
Implant
x-
CabazitaxelJevtana KitOncologicInjectable: Solution (IV, Kit)xExpired
CabotegravirCabenuva KitAnti-HIVInjectable: SuspensionxExpired
CannabidiolEpidiolexAnti-epilepticOral: SolutionxExpired
CytisineCytisinicliineNicotine addictionOral: TabletsxExpected: TBD
Dalbavancin HClDalvanceAntibacterialInjectable: Powder for IVxExpired
Difelikefalin AcetateKorsuvaAnti-pruriticInjectable: IV solution x8/23/26
EdaravoneRadicava ORS, RadicavaAmyotrophic lateral sclerosis (ALS)Oral: Suspension
Injectable: IV Solution
xExpired
Edoxaban TosylateSavaysaAnti-thromboticOral: TabletsxExpired
EnsifentrineOhtuvayreMaintenance treatment of chronic obstructive pulmonary disease (COPD)Nasal: Inhalerx6/26/2029
Esketamine HClSpravatoAntidepressantNasal: SprayxExpired
EstetrolNextstellisContraceptive Oral: Film Coated TabletsxExpired
EtonogestrelNexplanonContraceptive Implant (subcutaneous)x-
EtripamilCardaMystTo terminate episodes of paroxysmal supraventricular tachycardia (PSVT) Nasal: Sprayx1/12/30
Ferric CarboxymaltoseInjectaferIron deficiencyInjectable: IV Solutionx-
Ferric DerisomaltoseMonoferricAnti-anemicInjectable: IV Solutionx-
FidaxomicinDificidAnti-diarrheaOral: Film Coated Tablets, Granules for SuspensionxExpired
Fosfomycin TrometamolMonurolUncomplicated urinary tract infectionsOral: Granules for solutionx-
Glucagon SyntheticBaquisimi, Gvoke Kit/PFS/Hypopen, Gvoke VialdxHypoglycemia, Diagnostic AidNasal: Powder
Injectable: Subcutaneous Solution - IV Solution
x-
Lanreotide Acetate Somatuline DepotEndocrine Gland DiseaseInjectable: Single Use Syringe (subcutaneous)x-
Latanoprostene BunodVyzultaGlaucomaOphthalmic: Solutionx-
LetermovirPrevymisPrevention of cytomegalovirus (CMV) infection Oral: Film Coated Tablets; Pellets
Injectable: Solution (IV)
xExpired
Loteprednol EtabonateAlrex, Eysuvis, Inveltys, Lotemax, Lotemax SMAnti-allergyOphthalmic: Gel, Suspension, Ointmentx-
Lumateperone TosylateCaplytaAntipsychotic Oral: Soft Gel Capsules xExpired
Omidenepag IsopropylOmlontiGlaucomaOphthalmic: Solutionx9/22/27
Ozanimod HydrochlorideZeposiaMSOral: CapsulesxExpired
PalbociclibIbranceAdvanced or metastatic breast cancerOral: Tablets, CapsulesxExpired
Patiromer Sorbitex Calcium VeltassaHyperkalemiaOral: Powder for SuspensionxExpired
PegcetacoplanSyfovre, EmpaveliOphthalmic: Injectable Solution
Injectable: Subcutaneous solution
Expired
PlecanatideTrulanceConstipationOral: TabletsxExpired
Pramlintide Acetate SymlinDiabetesInjectable: Solution (subcutaneous, pen)xExpired
Remimazolam BesylateByfavoSedativeInjectable: Lyophilized PowderxExpired
ResmetiromRezdriffaMASHOral: Film Coated Tabletsx3/14/29
RezafunginRezzayoAntifungalInjectable: Powderx3/22/33
Ribociclib Succinate Kisqali            OncologicOral: TabletsxExpired
RilpivirineCabenuva KitAnti-HIVInjectable: SuspensionxExpired
Salmon CalcitoninMiacalcinCalcium metabolism modifierNasal: Spray
Injectable: Solution
x-
Selumetinib SulfateKoselugo Neuro fibromatosisOral: Capsules, GranulesxExpired
Sepetaprost TBDOpen Angle Galucoma and Ocular HypertensionOphthalmic: Solution xTBD
Setmelanotide AcetateImcivreeObesityInjectable: Solution (Subcutaneous)xExpired
SpinosadNatroba Antiparasitic agentTopical: Suspensionx-
TapinarofVtamaPsoriasis TreatmentTopical: Creamx5/23/27
TeduglutideGattex KitShort Bowel SyndromeInjectable: Powder for reconstitution (subcutaneous)xExpired
Tenapanor HClIbsrela, XphozahIrritable bowel syndrome and chronic kidney disease Oral: Film Coated TabletsExpired
Terlipressin AcetateTerlivazIimprove kidney function Injectable: Lyophilized Powder for Reconstitutionx9/14/27
Thyroid (Natural desiccated thyroid)Armour Thyroid, NP Thyroid, Nature-Throid, WT ThyroidHypothyroidismOral: Tabletsx-
TirbanibulinKlisyriKeratosisTopical: OintmentxExpired
Treprostinil DiolamineOrenitram Pulmonary arterial hypertensionOral: ER Tabletsx-
TreosulfanGrafapexPrep regiment for stem cell transplantation Injectable: Lyophilized Powder ( IV)x1/21/30
Trilaciclib DihydrochlorideCoselaDecrease of chemotherapy-induced myelo suppressionInjectable: Lyophilized Powder (IV)xExpired
VoclosporinLupkynisLupus Oral: Softgel CapsulesxExpired
VosoritideVoxzogoAchondroplasiaInjectable: Powder (subcutaneous)x11/19/26
ZuranoloneZurzuvae Antidepressant, Post-Partum DepressionOral: Capsulesx10/31/28