NILUTAMIDE Drug Patent Profile
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Which patents cover Nilutamide, and when can generic versions of Nilutamide launch?
Nilutamide is a drug marketed by Ani Pharms and is included in one NDA.
The generic ingredient in NILUTAMIDE is nilutamide. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nilutamide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nilutamide
A generic version of NILUTAMIDE was approved as nilutamide by ANI PHARMS on July 15th, 2016.
Summary for NILUTAMIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 112 |
| Clinical Trials: | 15 |
| Patent Applications: | 4,394 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NILUTAMIDE |
| What excipients (inactive ingredients) are in NILUTAMIDE? | NILUTAMIDE excipients list |
| DailyMed Link: | NILUTAMIDE at DailyMed |
Recent Clinical Trials for NILUTAMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| PPD | Phase 3 |
| Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair | Phase 3 |
| Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair | Phase 3 |
Pharmacology for NILUTAMIDE
| Drug Class | Androgen Receptor Inhibitor |
| Mechanism of Action | Androgen Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for NILUTAMIDE
US Patents and Regulatory Information for NILUTAMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | NILUTAMIDE | nilutamide | TABLET;ORAL | 207631-001 | Jul 15, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
