NILANDRON Drug Patent Profile
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When do Nilandron patents expire, and when can generic versions of Nilandron launch?
Nilandron is a drug marketed by Concordia and is included in one NDA.
The generic ingredient in NILANDRON 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 Nilandron
A generic version of NILANDRON was approved as nilutamide by ANI PHARMS on July 15th, 2016.
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Questions you can ask:
- What is the 5 year forecast for NILANDRON?
- What are the global sales for NILANDRON?
- What is Average Wholesale Price for NILANDRON?
Summary for NILANDRON
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 112 |
| Clinical Trials: | 6 |
| Patent Applications: | 2,894 |
| Drug Prices: | Drug price information for NILANDRON |
| What excipients (inactive ingredients) are in NILANDRON? | NILANDRON excipients list |
| DailyMed Link: | NILANDRON at DailyMed |
Recent Clinical Trials for NILANDRON
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Southwest Oncology Group | Phase 3 |
| NRG Oncology | Phase 2/Phase 3 |
| National Cancer Institute (NCI) | Phase 2/Phase 3 |
Pharmacology for NILANDRON
| Drug Class | Androgen Receptor Inhibitor |
| Mechanism of Action | Androgen Receptor Antagonists |
US Patents and Regulatory Information for NILANDRON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Concordia | NILANDRON | nilutamide | TABLET;ORAL | 020169-001 | Sep 19, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Concordia | NILANDRON | nilutamide | TABLET;ORAL | 020169-002 | Apr 30, 1999 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
