First to file Opportunities | ANDA Filings

NCE Grid: Tracks key regulatory and exclusivity milestones for chemical (synthetic) drugs, helping pharma companies identify timely filing and market-entry opportunities.

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	Question 1	Answer 1	Question 2	Answer 2	Question 3	Answer 3	Question 4	Answer 4
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.	Who might benefit from taking Brenzavvy?	Adults with type 2 diabetes who are looking to improve their blood sugar control alongside diet and exercise may benefit from Brenzavvy.	What are the common side effects of Brenzavvy?	Common side effects may include urinary tract infections, increased urination, and genital yeast infections.	What is the generic for Brenzavvy?	Bexagliflozin is the generic for Brenzavvy	Are there any precautions or interactions while taking Brenzavvy?	Brenzavvy may interact with certain medications affecting kidney function. It's important to inform your healthcare provider about all the medications you're taking.
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	606	891	1,177	1,464	1,928	2,332	2,760	44.37%	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.	What are the common side effects of Jaypirca?	Common side effects of Jaypirca may include diarrhea, fatigue, and upper respiratory tract infections.	How does Jaypirca work differently from other BTK inhibitors?	Jaypirca is a non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor. This means that it continues to work even when cancer cells develop resistance to traditional covalent BTK inhibitors.
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	72	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.
Filspari	filspari	Sparsentan	sparsentan	17-Feb-23	17-Feb-28	17-Feb-27	TRAVERE THERAPEUTICS	Tablet	200 mg and 400 mg	Antiproteinuric	To Reduce Proteinuria In Adults With Primary Immunoglobulin	132	295	434	643	810	993	1,189	1,386	57.39%	Filspari is an oral dual endothelin and angiotensin receptor blocker approved to reduce proteinuria and slow kidney function decline in adults with IgA nephropathy.

NBE Grid: Monitors biologic drug pipelines and exclusivity timelines, enabling strategic insights into biosimilar development and competitive positioning.

Brand Name	Brand Name Slug	Molecule	Molecule Slug	Approval Date	Market Exclusivity Expiry	Data Exclusivity Expiry	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	Question 1	Answer 1	Question 2	Answer 2	Question 3	Answer 3	Question 4	Answer 4
Leqembi	leqembi	Lecanemab-Irmb	lecanemab-irmb	06-Jan-23	06-Jan-35	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	312	768	1,282	1,988	2,788	3,597	4,338	4,993	72.90%	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?	The most common side effects of LEQEMBI include infusion-related reactions, ARIA, and headaches.
Lamzede	lamzede	Velmanase Alfa-Tycv	velmanase-alfa-tycv	16-Feb-23	16-Feb-35	16-Feb-27	CHIESI FARMACEUTICI S.P.A.	Injection- IV	10 mg	Antimetabolic Disorder	To Treatment Of Non-Central Nervous System Manifestations Of Alpha-Mannosidosis In Adult And Pediatric Patients.	NA	NA	NA	NA	NA	NA	NA	NA	NA	Lamzede is the first enzyme replacement therapy for non-central nervous system manifestations of alpha-mannosidosis. It improves enzyme activity and reduces the buildup of serum oligosaccharides.
Zynyz	zynyz	Retifanlimab-Dlwr	retifanlimab-dlwr	22-Mar-23	22-Mar-35	22-Mar-27	INCYTE	Intravenous Injection	500mg/20ml	Anticancer	It Is Indicated For The Treatment Of Adult Patients With Metastatic Or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC).	3	19	55	99	134	166	198	223	158.52%	Zynyz is the first PD‑1 inhibitor approved by the FDA for adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal. It is now available both as monotherapy and in combination with platinum‑based chemotherapy, and is also approved for metastatic Merkel cell carcinoma; it enhances T‑cell activity to target and slow tumor growth.
Elfabrio	elfabrio	Pegunigalsidase Alfa-Iwxj	pegunigalsidase-alfa-iwxj	09-May-23	09-May-35	09-May-27	PROTALIX BIOTHERAPEUTICS, INC.	Injection	20mg/10ml	Antimetabolic Disorder	To Treat Confirmed Fabry Disease	NA	29	NA	NA	NA	NA	50	NA	NA	Elfabrio is the first PEGylated enzyme replacement therapy approved by the FDA for adults with Fabry disease. It provides exogenous alpha‑galactosidase A to reduce globotriaosylceramide accumulation and improve organ function.
Epkinly	epkinly	Epcoritamab-Bysp	epcoritamab-bysp	19-May-23	19-May-35	19-May-27	GENMAB AND ABBVIE	Injection	4 mg/0.8 mL and 48 mg/0.8 mL	Anticancer	To Treat Relapsed Or Refractory Diffuse Large B-Cell Lymphoma (Not Otherwise Specified) And High-Grade B-Cell Lymphoma After Two Or More Lines Of Systemic Therapy	399	734	1,236	1,971	2,608	3,190	3,668	4,080	59.89%	Epkinly is an injection used for certain types of blood cancer like large B-cell lymphoma. It helps immune cells find and destroy cancer cells.

***Last Updated : 2025-Nov-17 13:00:00

**Note: Blank records are currently unavailable and will be updated in future versions.

**Disclaimer: Data is sourced from trusted, industry-standard databases for informational purposes only.

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