ESTABLISHED PRODUCTS

MARCH 2024 UPDATE

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API Name	Proprietary Name	Main Indication	Route, Dosage Form	R&D - Status	US DMF - Status
Alprostadil	Muse	Erectile dysfunction	Urethral: Suppository		x
Azelaic Acid	Azelex, Finacea	Anti-acne; Rosacea	Topical: Cream, Foam, Gel		x
Bimatoprost	Durysta, Latisse, Lumigan	Antiglaucoma Helps eyelash growth	Ophthalmic: Implant - Solution,Drops Topical: Solution,Drops		x
Carfilzomib	Kyprolis	Oncologic	Injectable: Powder for IV		x
Carprofen	Rimadyl (veterinary)	NSAID	Oral: Caplets, Chewable tablets Injectable: Solution		x
Ciclopirox Olamine	Loprox, Penlac	Antifungal	Topical: Cream, Shampoo, Suspension		x
Colchicine	Colcrys, Gloperba, Lodoco, Mitigare	Antigout Heart Disease	Oral: Tablets, Capsules, Suspension		x
Desmopressin Acetate	DDAVP, Stimate	Antidiuretic Hormone	Oral: Tablets Injectable: IV, Subcutaneous Nasal: Spray		x
Dexlansoprazole	Dexilant	Anti-ulcer	Oral: DR Capsules		x
Diclofenac Epolamine	Flector, Licart	Anti-rheumatic	Topical: Transdermal Patches		x
Diclofenac Potassium	Cambia, Zipsor	NSAID	Oral: Powder for solution, Soft Gel Capsules, Tablets		x
Diclofenac Sodium	Voltaren - Arthrotec- Pennsaid	NSAID	Oral: DR Tablets; ER Tablets Ophthalmic: Solution Topical: Gel; Solution		x
Difluprednate	Durezol	Corticosteroid	Ophthalmic: Emulsion		x
Docetaxel	Taxotere	Oncologic	Injectable: IV solution		x
Droxidopa	Northera	Cardiovascular	Oral: Capsules		x
Efinaconazole	Jublia	Antifungal	Topical: Solution		x
Etodolac	Lodine - Lodine XL	Anti-rheumatic	Oral: Tablets, ER Tablets, Capsules		x
Everolimus	Afinitor, Afinitor Disperz, Zortress	Oncologic; Immuno suppressant	Oral: Tablets, Tablets for Suspension		x
Fesoterodine Fumarate	Toviaz	Urinary Incontinence	Oral: ER Tablets		x
Flecainide Acetate	Tambocor	Anti-arrhythmic	Oral: Tablets		x
Ganirelix Acetate	Antagon	Infertility	Injectable: Pre-filled Syringe		x
Glipizide	Glucotrol, Glucotrol XL, Metaglip	Diabetes	Oral: Tablets, ER Tablets		x
Icatibant Acetate	Firazyr	Angioedema	Injectable: Pre-filled Syringe (subcutaneous)		x
Icosapent Ethyl (EPA)	Vascepa	Hyper triglyceridemia	Oral: Soft Gel Capsules		x
Imiquimod	Zyclara	Keratosis	Topical: Cream		x
Indomethacin	Indocin	Pain Treatment	Oral: Suspension, Capsules, ER Capsules		x
Latanoprost	Xalatan, Iyuzeh, Rocklatan, Xelpros	Glaucoma Treatment	Ophthalmic: Solution; Emulsion		x
Lidocaine Base	Lidoderm	Anesthetic	Topical: Ointment, Patch	x
Lidocaine HCl	Multiple	Anesthetic	Injectable: Solution Ophthalmic: Gel Oral: Solution Topical: Solution, Jelly	x
Loteprednol Etabonate	Alrex, Eysuvis, Inveltys, Lotemax, Lotemax SM	Anti-allergy	Ophthalmic: Gel, Suspension, Ointment		x
Lubiprostone	Amitiza	Laxative	Oral: Soft Gel Capsules		x
Lurasidone HCl	Latuda	Antipsychotic	Oral: Tablets		x
Meloxicam	Mobic, Vivlodex	NSAID	Oral: Tablets, Capsules, Suspension		x
1% Misoprostol HPMC	Arthrotec, Cytotec	Antiulcerant	Oral: Tablets, DR Tablets		x
Mycophenolate Mofetil	Cellcept	Immuno suppressant	Oral: Tablets, Capsules, Suspension		x
Mycophenolate Mofetil HCl	Cellcept	Immuno suppressant	Injectable: IV Infusion		x
Mycophenolate Sodium	Myfortic	Immuno suppressant	Oral: DR Tablets		x
Nepafenac	Ilevro, Nevanac	NSAID	Ophthalmic: Solution, Suspension		x
Obeticholic Acid	Ocaliva	GI Diseases	Oral: Tablets		x
Paclitaxel	Abraxane, Taxol	Oncologic	Injectable: IV Solution, Lyophilized Powder for IV		x
Paliperidone	Invega	Schizophrenia	Oral: ER Tablets		x
Paliperidone Palmitate	Invega Sustenna, Invega Trinza, Invega Hafyera	Schizophrenia	Injectable: ER Suspension (IM)		x
Prilocaine Base	Emla, Oraqix	Local Anesthetic	Topical: Cream, Periodontal Gel		x
Prilocaine HCl	Citanest, Citanest Forte, Citanest Forte Dental	Local Anesthetic	Injectable: Solution	x
Ranolazine	Ranexa, Aspruzyo Sprinle	Antianginal	Oral: ER Tablets, ER Granules (sachets)		x
Risperidone	Risperdal, Risperdal Consta, Rykindo, Perseris Kit, Uzedy	Antipsychotic	Oral: Tablets Injectable: Powder for Suspension (IM - subcut.), ER Suspension (prefilled syringe)		x
Rivastigmine Base	Exelon	Dementia treatment	Transdermal: Patches		x
Roflumilast	Daliresp, Zoryve	COPD - Psoriasis	Oral: Tablets Topical: Cream, Foam		x
Rotigotine	Neupro	Parkinson, Restless Leg Syndrome	Transdermal: Patches		x
Rufinamide	Banzel	Antiepileptic	Oral: Tablets		x
Sirolimus	Rapamune, Fyarro, Hyftor	Immuno suppressant	Oral: Tablets, Solution Injectable: Powder (IV) Topical: Gel		x
Solifenacin Succinate	VESicare, VESicare LS	Overreactive bladder and other genitourinary system diseases	Oral: Tablet, Suspension		x
Spironolactone	Aldactazide, Aldactone, CaroSpir	Antihypertensive	Oral: Tablets, Suspension		x
Tacrolimus	Prograf, Protopic, Astragraf XL	Immuno suppressant (Prograf) Dermatitis (Protropic)	Oral: Capsules, Granules for Suspension, ER Capsules Injectable: Solution (IV) Topical: Ointment		x
Tafluprost	Zioptan	Glaucoma Treatment	Ophthalmic: Solution		x
Tofacitinib Citrate	Xeljanz, XeljanzXR	Rheumatoid Arthritis	Oral: Tablets, ER Tablets, Solution		x
Tolterodine Tartrate	Detrol, Detrol LA	Overactive Bladder	Oral: Tablets, ER Capsules		x