NATCO Pharma has submitted Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (USFDA) for the generic version of Erdafitinib Tablets 3 mg, 4 mg, and 5 mg strengths. Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC). Erdafitinib Tablets are marketed in the United States (US) by Janssen Biotech under brand Balversa. NATCO has been named as defendant in a lawsuit filed in the US district court of New Jersey by Janssen Pharmaceutica NV, Janssen Biotech and Otsuka holdings’ Astex Therapeutics.
NATCO believes that the ANDA is possibly sole first-to-file based on its filing date and may be eligible for 180 days of marketing exclusivity at the time of launch. Balversa has recorded sales of $36.5 million in the US market for the year ending December 2022, as per IQVIA database.
Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1847.30 |
| Dr. Reddys Lab | 1293.25 |
| Cipla | 1347.70 |
| Zydus Lifesciences | 938.90 |
| Lupin | 2377.90 |
| View more.. | |
MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.
To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.
MoneyWorks4Me ensures this through: