Generic Launches

Fourth 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 NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Sensipar Amgen Cinacalcet Dr. Reddy's Labs Used to treat secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis; also used to treat hypercalcemia in adult patients with parathyroid carcinoma and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy 10/1/2020
Kuvan Biomarin Sapropterin Par Used to lower blood Phe levels in adults and children over one month of age with a certain type of phenylketonuria (PKU) 10/1/2020
Truvada/Atripla Gilead Emtricitabine / Tenofovir; Efavirenz / Emtricitabine / Tenofovir Teva Used to treat HIV-1 infection when used with other anti-HIV-1 medicines in adults and children who weigh at least 37 pounds; HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of getting HIV-1 infection in adults and adolescents who weigh at least 77 pounds 10/2/2020
Aptensio XR Rhodes Methylphenidate Teva Used to treat attention deficit hyperactivity disorder (ADHD) in patients 6 years and older 10/5/2020
Monurol Zambon Fosfomycin Xiromed Used as antibiotic to treat uncomplicated urinary tract infections (UTI) in women caused by certain types of bacteria 10/6/2020
Voltaren Glaxo Diclofenac gel 1% Amneal Used to relieve pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands 10/8/2020
Librax Bausch & Lomb Chlordiazepoxide / Clidinium bromide ECI Used to treat emotional distress caused by having a stomach disorder (such as an ulcer, irritable bowel syndrome, or intestinal infection) 10/30/2020
Tirosint IBSA Levothyroxine Lannett Used to treat adults and children 6 years of age and older who suffer from hypothyroidism or inadequate levels of thyroid hormone 11/3/2020
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 11/4/2020
Accolate Par Zafirlukast Camber / Hetero Used for chronic treatment of asthma, and to prevent asthma attacks in adults and children as young as 5 years old 11/5/2020
Vascepa Amarin Icosapent Hikma Used as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia 11/5/2020
Mycamine Astellas Micafungin Apotex Used to treat candidemia, acute disseminated candidiasis, and certain other invasive Candida infections, as well as esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation 11/5/2020
Gemmily (Taytulla) AbbVie Norethindrone / Ethinyl estradiol / Ferrous fumarate Xiromed Used as oral contraceptive by women to prevent pregnancy 11/9/2020
Sporanox Johnson & Johnson Itraconazole Camber / Hetero Used as an antifungal medication in adults to treat infections caused by fungus 11/11/2020
Quelicin Hospira Succinylcholine Dr. Reddy's Labs Used as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation 11/12/2020
DDAVP Ferring Desmopressin Apotex Used to control bleeding in people with mild hemophilia A. 11/19/2020
Exalgo Mallinckrodt Hydromorphone ER Hetero Used to treat chronic pain in opioid-tolerant patients requiring continuous around-the-clock opioid analgesia for an extended amount of time 11/24/2020
Prograf Astellas Tacrolimus Lupin Used for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, and in pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants 11/25/2020
Alinia Romark Nitazoxanide Rising Used to treat diarrhea caused by Giardia lamblia or Cryptosporidium
parvum.
11/30/2020
Entereg Glaxo Alvimopan Teva Used to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis 12/1/2020
Firazyr Takeda Icatibant Fresenius Kabi Used to treat acute attacks of hereditary angioedema in adults 18 years of age and older. 12/1/2020
Colcrys Takeda Colchicine Teva Used for prophylaxis and treatment of gout flares in adults and Familial Mediterranean fever (FMF) in adults and children 4 years or
older
12/3/2020
Yasmin Bayer Drospirenone / Ethinyl estradiol Hetero Used by women to prevent pregnancy 12/8/2020
Sensipar Amgen Cinacalcet Camber / Hetero Used for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis; also used for the treatment of hypercalcemia in adult patients with parathyroid carcinoma and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy 12/10/2020
Naropin Fresenius Kabi Ropivicaine Hikma Used for the production of local or regional anesthesia for surgery and for acute pain management 12/10/2020
Advair Diskus Glaxo Fluticasone / Salmeterol Hikma Used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema) 12/17/2020
Vivlodex Zyla Meloxicam Lupin Used for the management of osteoarthritis (OA) pain 12/17/2020
Prograf Astellas Tacrolimus Biocon Used for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, and in pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants 12/28/2020
CellCept Roche Mycophenolate mofetil Lupin Used for the prophylaxis of organ rejection in patients receiving allogeneic kidney, heart, or liver transplants 12/29/2020

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board

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