Generic Launches

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

Third Quarter

GENERICally Speaking

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
Astepro Allergy Bayer azelastine Amneal Used for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older 7/18/2022
Astepro Allergy Bayer azelastine Apotex Used for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older 7/18/2022
Astepro Allergy Bayer azelastine Aurobindo Used for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older 7/18/2022
Allegra D 24 Hr Sanofi fexofenadine / pseudoephedrine Dr. Reddy's Labs Used to treat the symptoms of sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold (Seasonal Allergic Rhinitis with Nasal Congestion) 7/22/2022
Prilosec AstraZeneca ompeprazole Apotex Used for short-term treatment (4 to 8 weeks) of active duodenal ulcer or active benign gastric ulcer in adults 8/10/2022
Sectral Promius acebutolol ANI Used to manage hypertension in adults 8/3/2022
Clindagel Bausch clindamycin Amneal Used for topical application in the treatment of acne vulgaris 8/11/2022
Vasostrict Endo / Par vasopressin Amneal Used to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines 8/11/2022
Vasostrict Endo / Par vasopressin Aurobindo Used to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines 8/16/2022
Desyrel Angelini trazodone Apotex Used to treat major depressive disorder (MDD) in adults 8/25/2022
Ryaltirs Hikma olopatadine / mometasone Hikma Used to treat moderate to severe nasal symptoms associated with allergic rhinitis 8/30/2022
Revlimid Celgene lenalidomide Lotus Used to treat adult patients with multiple myeloma (MM) 9/5/2022
Revlimid Celgene lenalidomide Dr. Reddy's Used to treat adult patients with multiple myeloma (MM) 9/7/2022
Suprep Bowel Prep Kit Braintree sodium sulfate / potassium sulfate / magnesium sulfate Lupin Used to cleanse the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older 9/9/2022
Protopic Astellas tacrolimus Teva Used for short term and intermittent long term therapy in the
treatment of patients with moderate to severe atopic dermatitis
9/9/2022
Tazorac AbbVie tazarotene Cosette Used for topical treatment of stable plaque psoriasis 9/15/2022
Faslodex AstraZeneca fulvestrant Hikma Used to treat HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy 9/20/2022
Velcade Sanofi bortezomib Hikma Used to treat patients with mantle cell lymphoma 9/20/2022
Revlimid Celgene lenalidomide Zydus Used to treat adult patients with multiple myeloma (MM) 9/20/2022
Samsca Otsuka tolvaptan Camber / Hetero Used to treat clinically significant hypervolemic and euvolemic hyponatremia 9/23/2022
Vesicare Astellas solifenacin Camber / Hetero Used to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency 9/28/2022
Revatio Mylan sildenafil Lupin Used to treat pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening 9/29/2022

Oren D. Langer

Partner

Managing Partner, New York Office

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