Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - Generic Launches

Robins Kaplan LLP
Contact
LinkedIn
Facebook
X
Send
Embed

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
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

[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

PUBLISH YOUR CONTENT ON JD SUPRA NOW

  • Increased visibility
  • Actionable analytics
  • Ongoing guidance

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