Generic Launches

Summer 2019

GENERICally Speaking: A Hatch Waxman Litigation Bulletin
Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Tygacil Pfizer tigecycline Apotex used to treat infections caused by susceptible strains of the designated microorganisms in complicated skin and skin structure Infections, complicated intra-abdominal Infections and community-acquired bacterial pneumonia 4/3/2019
Abreva Glaxo docosanol Teva used to treat cold sores/fever blisters on the face or lips, shortens healing time and duration of symptoms 4/3/2019
Invanz Merck ertapenem Apotex 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, compicated urinary tract infections including pyelonephritis and acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections 4/4/2019
Proventil Merck albuterol Endo's Par used to treat shortness of breath associated with asthma and chronic obstructive pulmonary disease 4/5/2019
Xeloda Roche capecitabine Armas used to treat colon cancer, and breast or colorectal cancer that has spread to other parts of the body 4/9/2019
Gleevec Roche imatinib Armas used to treat certain types of leukemia (blood cancer), bone marrow disorders, and skin cancer. Imatinib is also used to treat certain tumors of the stomach and digestive system 4/9/2019
Androgel AbbVie testosterone Teva used as replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism (congenital or acquired) 4/11/2019
Vesicare Astellas solifenacin Teva used for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency 4/22/2019
Letairis Gilead ambrisentan Cipla used for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening 4/30/2019
Letairis Gilead ambrisentan Teva used for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening 5/1/2019
Androgel AbbVie testosterone Dr. Reddy’s Labs. used as replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism (congenital or acquired) 5/6/2019
Namenda XR Allergan memantine Apotex used for the treatment of moderate to severe dementia of the Alzheimer’s type 5/10/2019
Onfi Lundbeck clobazam Lupin used for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 2 years of age or older 5/10/2019
Tarceva OSI erlotinib Mylan used for the treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen and also for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine 5/10/2019
Tarceva OSI erlotinib Teva used for the treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen and also for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine 5/10/2019
Delzicol Allergan mesalamine Teva used for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older, and for the maintenance of remission of ulcerative colitis in adults 5/10/2019
Cuprimine Bausch & Lomb penicillamine Amerigen used for the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy 5/13/2019
Cubicin Merck daptomycin Dr. Reddy’s Labs. used for treating complicated skin infections 5/15/2019
Adderall IR Shire dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate Lannett used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy 5/16/2019
Cardizem CD Bausch & Lomb diltiazem TWi used for the treatment of hypertension and for the management of chronic stable angina and angina due to coronary artery spasm 5/16/2019
Vesicare Astellas solifenacin Apotex used for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency 5/21/2019
Pulmicort Respules AstraZeneca budesonide Lupin used for the maintenance treatment of asthma and as prophylactic therapy in children from 12 months to 8 years of age 5/22/2019
Ranexa Gilead ranolazine Teva used for the treatment of chronic angina 5/28/2019
Concerta Johnson & Johnson methylphenidate Lannett used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) 5/29/2019
Benadryl Johnson & Johnson diphenhydramine Armas used for the treatment of seasonal allergies, insect bites and stings, and rashes 5/31/2019
Faslodex AstraZeneca fulvestrant Sandoz used for treatment of estrogen receptor positive metastatic breast cancer (cancer that has spread) in postmenopausal women, with disease progression following antiestrogen therapy 5/31/2019
Tracleer Actelion bosentan Hikma used for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adults 6/10/2019
Albenza Amneal albendazole Teva used to treat certain infections caused by worms such as pork tapeworm and dog tapeworm 6/14/2019
K-Tab AbbVie potassium chloride Adare Pharms used to treat or prevent low amounts of potassium in the blood 6/5/2019
Aggrenox Boehringer Ingelheim aspirin / dipyridamole Lannett used to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis 6/19/2019
Tracleer Actelion bosentan Teva used for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adults 6/20/2019
Precedex Hospira dexmedetomidine Fresenius Kabi used for sedation of non-intubated patients prior to and/or during surgical and other procedures 6/21/2019
Canasa Allergan mesalamine Amring Pharms used for the treatment of active ulcerative proctitis 6/25/2019
Diclegis Duchesnay doxylamine succinate / pyridoxine HCl Teva used for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management 6/25/2019
Tobi Mylan tobramycin Dr. Reddy’s Labs. used for the management of cystic fibrosis patients with P. aeruginosa 6/26/2019
Vitamin K1 -- phytonadione Dr. Reddy’s Labs. used to treat and prevent low levels of certain substances (blood clotting factors) that your body naturally produces 6/26/2019
Canasa Allergan mesalamine Rising used for the treatment of mildly to moderately active ulcerative proctitis 6/26/2019
Lotemax Bausch & Lomb loteprednol etabonate Akorn used  for the treatment of post-operative inflammation following ocular surgery and the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation 6/28/2019

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
Back to Top