Generic Launches - Fourth Quarter 2025

Robins Kaplan LLP
Contact
LinkedIn
Facebook
X
Send
Embed

Robins Kaplan LLP

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
Victoza Novo-Nordisk liraglutide Lupin Used as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older, with type 2 diabetes mellitus. 10/3/2025
Ravicti Amgen glycerol phenylbutyrate Endo  Used as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.  10/20/2025
Naropin Fresenius Kabi ropivacaine Glenmark Used as a local or regional anesthesia for surgery and for acute pain management.  10/23/2025
Ravicti Amgen glycerol phenylbutyrate Lupin  Used as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.  10/24/2025
Brekiya Amneal dihydroergotamine mesylate Amneal Used for the acute treatment of migraine with or without aura and acute cluster headaches in adults. 10/27/2025
Restasis AbbVie cyclosporine Teva Used to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (chronic dry eye). 10/28/2025
Dalvance AbbVie dalbavancin Teva Used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults and children. 10/29/2025
Tasigna Novartis nilotinib Camber Used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) for pediatric patients greater than or equal to 1 year of age and adults, based on various stages of disease diagnosis, disease progression, and previous treatment results. 12/2/2025
Gleevec Novartis imatinib mesylate Hetero  Used to treat specific types of leukemia, gastrointestinal tumors, and other rare cancers. 12/4/2025
Adzenys XR-ODT Neos amphetamine Teva Used to treat ADHD. 12/8/2025
Tyzavan Hikma vancomycin Hikma Used to treat the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: (i) septicemia; (ii) infective endocarditis; (iii) skin and skin structure infections; (iv) bone infections; and (v) lower respiratory tract infections. 12/8/2025
Leucovorin Calcium for Injection Hospira leucovorin calcium for injection Glenmark Used as a combination therapy with the cancer medication methotrexate to protect healthy cells and reduce toxic side effects. It is also used in the treatment of anemia. 12/11/2025
Javadin Azurity clonidine hydrochloride Azurity Used  to treat hypertension in adult patients to lower blood pressure. 12/18/2025
Epinephrine Injection BPI epinephrine injection Glenmark Used as the first-line and immediate emergency treatment for anaphylaxis. 12/23/2025

[View source.]

Send Print Report

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.

© Robins Kaplan LLP

Written by:

Robins Kaplan LLP
Robins Kaplan LLP
Contact
more
less

What do you want from legal thought leadership?

Please take our short survey – your perspective helps to shape how firms create relevant, useful content that addresses your needs:

Robins Kaplan LLP on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign Up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide