Generic Launches

Abbreviated New Drug Applications and 505(b)(2) Applications

Second Quarter

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.

Reference Listed Drug ANDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Astelin MEDA azelastine Aurobindo Used for the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older and perennial allergic rhinitis in patients 6 years of age and older 4/6/2021
Kuvan Biomarin saproterin Dr. Reddy's Used to lower blood Phe levels in adults and children over one month of age with a certain type of Phenylketonuria (PKU) 4/7/2021
Urocit-K Mission potassium citrate Hetero/Camber  Used for preventing certain types of kidney stones 4/8/2021
Librax Bausch & Lomb chlordiazepoxide / clidinium Xiromed Used to treat emotional distress caused by having a stomach disorder (such as an ulcer, irritable bowel syndrome, or intestinal infection) 4/9/2021
Quelicin Hospira succinylcholine chloride Nexus Used as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation 4/16/2021
Sabril Lundbeck vigabatrin Hetero/Camber Used to treat Refractory Complex Partial Seizures and Infantile Spasms 4/20/2021
Bloxiverz Exela neostigamine Hetero/Camber Used to reverse the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery 4/22/2021
Canasa AbbVie mesalamine Teva Used to treat mildly to moderately active ulcerative proctitis 4/23/2021
Absorica Sun isotretinoin Teva Used to manage of severe recalcitrant nodular acne in patients 12 years of age and older 4/29/2021
Enablex APIL darifenacin Xiromed Used to treat overactive bladder with symptoms of urge urinary incontinence, urgency and frequency 5/5/2021
Precedex Pfizer dexmedetomidine Hikma Used for sedation of non-intubated patients prior to and/or during surgical and other procedures 5/6/2021
Taxotere Sanofi docetaxel Hikma Microtubule inhibitor indicated for the treatment of breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, and squamous cell carcinoma of the head and neck cancer 5/7/2021
Invanz Merck ertapenem Dr. Reddy's Used to treat adult patients and pediatric patients (3 months of age and older) with the moderate to severe infections caused by susceptible isolates of the designated microorganisms in complicated intra-abdominal infections, complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis, community acquired pneumonia, complicated urinary tract infections including pyelonephritis and acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections 5/12/2021
Thiola Mission tiopronin Teva Used, in combination with high fluid intake, alkali, and diet modification, for the prevention of cysteine (kidney) stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone 5/17/2021
Miacalcin Mylan calcitonin salmon Leucadia/Custopharm Used for the early treatment of hypercalcemic emergencies when a rapid decrease in serum calcium is required 5/17/2021
Torisel Pfizer temsirolimus Fresenius Kabi Used to treat advanced renal cell carcinoma 5/21/2021
Strattera Eli Lilly atamoxetine Hetero/Camber Used to treat attention-deficit/hyperactivity disorder (ADHD) 5/24/2021
Vigamox Novartis moxifloxacin Upsher-Smith Used to treat bacterial conjunctivitis caused by susceptible strains of the organisms 5/27/2021
Banzel Eisai rufinamide Hetero/Camber Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults 6/1/2021
Banzel Eisai rufinamide Glenmark Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults 6/1/2021
Delestrogen Sandoz estradiol valerate Hikma Used for the treatment of vasomotor symptoms associated with menopause; (ii) in the management of hormonal imbalances due to castration or primary ovarian failure; and (iii) in the treatment of androgen-dependent carcinoma of the prostate. 6/2/2021
Brovana Sunovion arformoterol Lupin Used for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 6/3/2021
Kaletra AbbVie lopinavir / ritonavir Hetero/Camber Used with other HIV medications to help control HIV infection 6/7/2021
Prevacid Takeda lansoprazole Hetero/Camber Used to treat high levels of stomach acid; active ulcers of the stomach and small intestine, Gastroesophageal Reflux Disease (GERD), and Zollinger-Ellison Syndrome 6/15/2021
Soolantra Galderma ivermectin Teva Used to treat inflammatory lesions of rosacea. 6/16/2021
Truvada Gilead emtricitabine / tenofovir Apotex Used, in combination with other antiretroviral agents for the treatment of HIV-1 infection 6/18/2021
Vascepa Amarin icosapent Dr. Reddy's Used as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia 6/22/2021
Perforomist Mylan formoterol Teva Used with a nebulizer to control the symptoms of COPD in adults, including those with chronic bronchitis and/or emphysema, the two main types of the disease 6/22/2021
Banzel Eisai rufinamide Hikma Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults 6/24/2021
Truvada Gilead emtricitabine / tenofovir Lupin Used, in combination with other antiretroviral agents for the treatment of HIV-1 infection 6/25/2021
Absorica Sun isotretinoin Upsher-Smith/Sawai Used to manage severe recalcitrant nodular acne in patients 12 years of age and older 6/25/2021
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