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
Oracea	Galderma	doxycycline	Lupin	Used for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.	4/9/2024
Fleqsuvy	Azurity	baclofen	ANI	Used for the treatment of pain and certain types of spasticity (muscle stiffness and tightness) from multiple sclerosis, spinal cord injuries, or other spinal cord diseases.	4/9/2024
Toviaz	Hetero	fesoterodine fumerate	Camber	Used for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.	4/17/2024
Myrbetriq ER	Astellas	mirabegron	Lupin	Used for the treatment of overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.	4/20/2024
Myrbetriq ER	Astellas	mirabegron	Zydus	Used for the treatment of overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.	4/22/2024
EstroGel	Ascend	estradiol	Solaris	Used for the treatment of moderate to severe vasomotor symptoms due to menopause, and for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.	4/25/2024
Abilify OS	Bristol-Myers Squibb	aripiprazole	Camber	Used for the treatment of schizophrenia, Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, Irritability Associated with Autistic Disorder, Treatment of Tourette’s Disorder	4/26/2024
Cupric Chloride	Hospira	cupric chloride	Somerset Therapeutics	Used as a supplement to intravenous solutions given for TPN. Administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.	5/1/2024
Viibryd	AbbVie	vilazodone	Apotex	Used for the treatment of major depressive disorder (MDD).	5/2/2024
Oracea	Galderma	doxycycline	Dr. Reddy's Labs	Used for the treatment of bacterial infections, including acne, rosacea, urinary and respiratory tract infections, eye infections, gum disease, gonorrhea, chlamydia, and syphilis. Doxycycline can also be used to prevent malaria and treat infections caused by mites, ticks, or lice.	5/3/2024
Cialis	Eli Lilly	tadalafil	TWi	Used for the treatment of erectile dysfunction (ED, impotence; inability to get or keep an erection), and the symptoms of benign prostatic hyperplasia (BPH; an enlarged prostate) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency in adult men.	5/6/2024
Halaven	Eisai	eribulin	Apotex	Used for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.	5/7/2024
Esbriet	Genentech	pirfenidone	Apotex	Used for the treatment of idiopathic pulmonary fibrosis (IPF).	5/8/2024
Cetrotide	Merck	cetrorelix	Apotex	Used for the prevention of premature ovulation in women undergoing controlled ovarian stimulation therapy followed by oocyte retrieval and assisted reproductive technology.	5/14/2024
Narcan	Emergent	naloxone	Walgreens	Used for the reversal of an opioid overdose or suspected opioid overdose: it is intended for immediate administration as emergency therapy in settings where opioids may be present	5/15/2024
Banzel	Eisai	rufinamide	Camber	Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults.	5/16/2024
Norepinephrine Bitartrate	Long Grove	norepinephrine bitartrate	Long Grove	Used for to raise blood pressure in adult patients with severe, acute hypotension, and it is one of the most commonly used injectable medications in the critical care setting.	5/22/2024
Vibramycin	Pfizer	doxycycline	Lupin	Used for to reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline and other antibacterial drugs.	6/3/2024
Sodium Acetate	Hospira	sodium acetate	Hikma	Used for as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake.	7/11/2024