Generic Drug Launches and 505b2 Applications Winter 2021

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