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Generic Launches
Fourth Quarter
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 |
GENERICally Speaking Winter 2021
Related Professionals
Christopher A. Pinahs
Partner
GENERICally Speaking Winter 2021
VOL. 10, NO. 4 Related Publications
Fourth Quarter
GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Oren Langer, Christopher Pinahs, Emily Tremblay, and Christine May
December 29, 2023
Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc.
GENERICally Speaking Hatch Waxman Bulletin
December 13, 2023
Acadia Pharms. Inc. v. Aurobindo Pharma Ltd.
GENERICally Speaking Hatch Waxman Bulletin
December 7, 2023
H. Lundbeck A/S v. Lupin Ltd.
GENERICally Speaking Hatch Waxman Bulletin
November 7, 2023
Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc.
GENERICally Speaking Hatch Waxman Bulletin
Related News
October 14, 2022
September 9, 2022
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