Generic Launches

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

Second Quarter

GENERICally Speaking

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
Camcevi Accord leuprolide Accord Used in men to treat the symptoms of prostate cancer; used in women to treat symptoms of endometriosis or uterine fibroids 4/4/2022
Lyrica Pfizer pregabalin Apotex Used to treat pain caused by nerve damage due to diabetes, shingles (herpes zoster) infection, or spinal cord injury 4/4/2022
Solu-Medrol Pfizer methylprednisolone Dr. Reddy's Used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders 4/5/2022
Merzee AbbVie ethinyl estradiol / norethindrone / ferrous fumarate Lupin Used to prevent pregnancy 4/7/2022
Cytotec Pfizer misoprostol ANI Used to prevent stomach ulcers while you take NSAIDs (such as aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers 4/11/2022
Abraxane Celgene paclitaxel Apotex Used to treat metastatic breast cancer, non-small cell lung cancer and adenocarcinoma of the pancreas 4/12/2022
Combigan AbbVie brimonidine / timolol Sandoz Used to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (such as ocular hypertension) 4/14/2022
Veltin Almirall clindamycin/tretinoin Solaris Used to treat acne 4/14/2022
Abraxane AbbVie paclitaxel TWi Used to treat metastatic breast cancer, non-small cell lung cancer and adenocarcinoma of the pancreas 4/18/2022
Vimpat UCB lacosamide Breckenridge Used to prevent and control seizures 4/19/2022
Velcade Takeda bortezomib Baxter Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) 4/29/2022
Velcade Takeda bortezomib Fresenius Kabi Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) 4/29/2022
Velcade Takeda bortezomib Apotex Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) 5/2/2022
Progesterone Teva progesterone Xiromed Used to prevent endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets 5/2/2022
Velcade Takeda bortezomib Aurobindo Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) 5/3/2022
Velcade Takeda bortezomib Zydus Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) 5/3/2022
Velcade Takeda bortezomib Gland Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) 5/4/2022
Velcade Takeda bortezomib Hospira Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) 5/4/2022
Reyataz Bristol-Myers Squibb atazanavir Hetero / Camber Used with other HIV medications for infants and children to help control HIV infection 5/11/2022
Esbriet Genentech pirfenidone Teva Used to treat idiopathic pulmonary fibrosis (IPF) 5/12/2022
Esbriet Genentech pirfenidone Sandoz Used to treat idiopathic pulmonary fibrosis (IPF) 5/13/2022
Transderm Scop Baxter scopolamine Teva Used to prevent nausea and vomiting caused by motion sickness or recovery from anesthesia and surgery 5/13/2022
Atripla Gilead efavirenz / emtricitabine / tenofovir Hetero / Camber Used alone or with other HIV medications to help control HIV infection 5/16/2022
Abreva Glaxo docosanol Cosette Used to treat "cold sores/fever blisters" (herpes labialis) 5/24/2022
Fosrenol Takeda lanthanum Teva Used to lower phosphate levels in patients with end stage kidney disease 5/26/2022
Ampyra Acorda dalfampridine Teva Used to help improve walking in adults with multiple sclerosis (MS) 6/1/2022
Lyvispah Amneal baclofen Amneal Used to treat muscle stiffness, spasms, and pain from multiple sclerosis 6/1/2022
Pepcid Johnson & Johnson famotidine Hetero / Camber Used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion) 6/1/2022
Trileptal Novartis oxcarbazepine Hetero / Camber Used to treat the symptoms of seizures (convulsions) 6/2/2022
CellCept Roche mycophenolate Teva Used to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant 6/3/2022
Viibryd AbbVie vilazodone Apotex Used to treat major depressive disorder (MDD) 6/6/2022
Truvada Gilead emtricitabine / tenofovir Hetero / Camber Used to treat human immunodeficiency virus (HIV) and hepatitis B virus infection 6/17/2022
Epiduo Forte Galderma adapalene Padagis Used to treat the symptoms of Acne Vulgaris 6/21/2022
Narcan Adapt naloxone Padagis Used to treat a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond 6/21/2022
Samsca Otsuka tolvaptan Apotex Used to treat hyponatremia (low levels of sodium in the blood) in people who have heart failure (condition in which the heart cannot pump enough blood to all parts of the body), syndrome of inappropriate antidiuretic hormone (SIADH; condition in which the body produces too much of a certain natural substance that causes the body to retain water) or other conditions 6/22/2022
Esbriet Genentech pirfenidone Alembic Used to treat idiopathic pulmonary fibrosis (IPF) 6/27/2022

Oren D. Langer

Partner

Managing Partner, New York Office

Related Publications

Second Quarter
ANDA Approvals
GENERICally Speaking Hatch Waxman Bulletin
Second Quarter
ANDA Litigation Settlements
GENERICally Speaking Hatch Waxman Bulletin
Second Quarter
New ANDA Cases
GENERICally Speaking Hatch Waxman Bulletin
June 21, 2022
Novartis Pharms. Corp. v. Accord Healthcare, Inc.
GENERICally Speaking Hatch Waxman Bulletin
May 20, 2022
Bausch Health Ireland, Ltd. v. Padagis Israel Pharms., Ltd.
GENERICally Speaking Hatch Waxman Bulletin
Back to Top