Generic Launches - Winter 2024

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Fourth Quarter

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

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

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
Sandostatin LAR Depot Novartis octreotide acetate Teva Used to treat severe diarrhea and flushing episodes associated with metastatic carcinoid tumors, profuse watery diarrhea associated with VIP-secreting tumors, and for long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option to reduce GH and IGF-1 levels to normal. 10/1/2024
Thiola EC Mission tiopronin delayed-release tablets Teva Used together with high fluid intake, alkali, and diet to prevent kidney stones in patients with severe homozygous cystinuria (too much cystine in the urine). 10/8/2024
Abraxane Bristol-Myers paclitaxel Sandoz Used to treat patients with metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. 10/11/2024
Pred Forte AbbVie prednisolone acetate Lupin Used to treat certain eye conditions due to inflammation or injury. 10/15/2024
Bumex Validus bumetanide injection Lupin Used to treat edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. 11/19/2024
Stromectol Merck Sharp and Dohme ivermectin tablets Dr. Reddy's Labs Used to treat onchocerciasis, but may also be effective against other worm infestations (such as strongyloidiasis, ascariasis, trichuriasis and enterobiasis). Applied topically, it may be used in the treatment of head lice infestation. 11/26/2024
Travatan Z Sandoz travoprost opthalmic solution Glenmark Used to treat glaucoma and ocular hypertension. 11/27/2024
Adrenalin Endo epinephrine in 0.9% sodium chloride injection Endo Used to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. 12/2/2024
DOXY 100 Fresenius Kabi doxycyclin for injection Endo Used to treat or prevent bacterial infections, including pneumonia and other respiratory tract infections. It is also used to treat certain skin, genital, intestine, and urinary system infections 12/10/2024
Vimpat UCB lacosamide Glenmark Used to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures. It acts on the central nervous system (CNS) to reduce the number and severity of seizures 12/16/2024
Vyvanse Takeda lisdexamfetamine dimesylate Teva Used to to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children 6 years of age and older. 12/17/2024
Epinephrine BPI Labs epinephrine injection Fresenius Kabi Used for the emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. 12/17/2024
Tykerb Novartis lapatinib tablets Teva Used for the emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substance 12/19/2024

[View source.]

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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