Generic Drug Launches and 505b2 Applications

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

Third 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
Abraxane	Bristol-Myers Squibb	paclitaxel	Teva	Used to treat various types of cancer. Indications for using paclitaxel encompass a range of cancers, including breast, ovarian, bladder, lung, prostate, melanoma, esophageal, Kaposi sarcoma, and various other solid tumors.	7/2/2024
Lunesta	Waylis	eszopiclone	Camber	Used to treat insomnia.	6/7/2024
Focinvez	Steriscience	fosaprepitant dimeglumine	Steriscience / Amneal	Used to prevent: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).	7/9/2024
Tirosint	IBSA	levothyroxine sodium	Yaral	Used to treat primary, secondary, and tertiary hypothyroidism.	7/9/2024
Thiola EC	Travere	tiopronin	Endo	Used to prevent kidney stones in patients with severe homozygous cystinuria (too much cystine in the urine).	7/15/2024
Zinc Sulfate	American Regent	zinc sulfate	Apotex	Used as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated	8/1/2024
Doxil	Baxter Healthcare	doxorubicin	Lupin	Used to treat Ovarian Cancer, Acquired Immune Deficiency Syndrome (AIDS)-related Kaposi’s Sarcoma, and Multiple Myeloma.	8/29/2024
Myrbetriq ER	Astellas	mirabegron	Lupin	Used to manage overactive bladder.	9/4/2024
Sprycel	Bristol-Myers Squibb	dasatinib	Apotex	Used to treat certain types of leukemia in both adults and children 1 year of age and older, including cases where previous treatment were not effective or tolerated.	9/5/2024
Oxtellar XR	Supernus	oxcarbazepine	Apotex	Used to treat partial-onset seizures in patients 6 years of age and older.	9/5/2024
Foscavir	Clinagen	foscarnet sodium	Hikma	Used to treat CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).	9/23/2024
Narcan	Adapt	naloxone	Teva	Used to rapidly reverse opioid overdose.	9/23/2024