Generic Drug Launches and 505b2 Applications

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

Second 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	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