First to file Opportunities | ANDA Filings - NCE Grid

NCE Grid

Brand Name	Brand Name Slug	Molecule	Molecule Slug	Approval Date	NCE Date	NCE-1 Date	Innovator	Dosage Form	Strength	Therapeutic Category	Usage	Revenue ($M)	Projected Sales By 2025 ($M)	Projected Sales By 2026 ($M)	Projected Sales By 2027 ($M)	Projected Sales By 2028 ($M)	Projected Sales By 2029 ($M)	Projected Sales By 2030 ($M)	Projected Sales By 2031 ($M)	CAGR (%)	Description	Youtube Link	Question 1	Answer 1	Question 2	Answer 2	Question 3	Answer 3	Question 4	Answer 4	Question 5	Answer 5
Leqembi	leqembi	Lecanemab-Irmb	lecanemab-irmb	06-Jan-23	06-Jan-28	06-Jan-27	EISAI INC.	Injection	500 mg/5 mL (100 mg/mL), 200 mg/2 mL (100 mg/mL)	Antialzheimer	To Treat Alzheimer’s Disease	291	791	1,402	2,169	3,063	3,836	4,608	5,279	80.12%	Leqembi is a prescription medicine for early-stage Alzheimer’s disease. It’s a monoclonal antibody that helps reduce amyloid plaques in the brain and is the first treatment of its kind approved in the European Union.		What is Leqembi and how does it work?	Leqembi is a monoclonal antibody treatment for early-stage Alzheimer's disease. It works by targeting and reducing amyloid plaques in the brain, potentially helping to slow cognitive decline in patients with mild cognitive impairment or mild dementia.	Who is eligible for Leqembi treatment?	Leqembi is for patients with early-stage Alzheimer's disease, specifically mild cognitive impairment or mild dementia. Patients must have confirmed elevated beta-amyloid in the brain through testing like PET scans or spinal fluid analysis.	How is Leqembi administered?	Leqembi is given as an IV infusion every two weeks at a healthcare facility. Each session requires medical supervision and regular monitoring by healthcare professionals.	What are the potential side effects and monitoring requirements?
Brenzavvy	brenzavvy	Bexagliflozin	bexagliflozin	20-Jan-23	20-Jan-28	20-Jan-27	THERACOSBIO LLC	Tablet	20mg	Antidiabetic	To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus As An Adjunct To Diet And Exercise	NA	663	764	845	928	1,015	NA	NA	NA	Brenzavvy is an SGLT2 inhibitor that helps lower your average blood sugar level over 90 to 120 days. It’s FDA-approved to be used alongside diet and exercise to manage blood sugar in adults with type 2 diabetes.
Jaypirca	jaypirca	Pirtobrutinib	pirtobrutinib	27-Jan-23	27-Jan-28	27-Jan-27	LOXO ONCOLOGY INC	Tablet	50mg,100mg	Anticancer	To Treat Relapsed Or Refractory Mantle Cell Lymphoma In Adults Who Have Had At Least Two Lines Of Systemic Therapy, Including A BTK Inhibitor	337	638	922	1,213	1,492	1,959	2,366	2,796	45.06%	Jaypirca is a non-covalent BTK inhibitor used to treat adults with relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukemia after prior treatments. It’s taken orally once daily.
Orserdu	orserdu	Elacestrant	elacestrant	27-Jan-23	27-Jan-28	27-Jan-27	STEMLINE THERAPEUTICS INC	Tablet	EQ 86MG BASE,EQ 345MG BASE	Hormonal Therapy	To Treat Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1-Mutated, Advanced Or Metastatic Breast Cancer With Disease Progression Following At Least One Line Of Endocrine Therapy	NA	6	28	58	98	139	174	212	NA	Orserdu is a once-daily selective estrogen receptor degrader (SERD) approved for ER-positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer in adults after endocrine therapy.
Jesduvroq	jesduvroq	Daprodustat	daprodustat	01-Feb-23	01-Feb-28	01-Feb-27	GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND	Tablet	1mg,2mg,4mg,6mg,8mg	Antianemic	To Treat Anemia Caused By Chronic Kidney Disease For Adults On Dialysis For At Least Four Months	NA	75	107	134	157	174	185	192	NA	Jesduvroq is an oral HIF-PHI approved for the treatment of anemia in adults with chronic kidney disease on dialysis. It was voluntarily withdrawn in the U.S. for non-safety-related reasons but remains FDA-listed.

***Last Updated : 2025-Sep-08 15:00:00

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