PRIMAQUINE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Primaquine, and what generic alternatives are available?
Primaquine is a drug marketed by Sanofi Aventis Us, Alvogen, Bayshore Pharms Llc, and Novast Labs. and is included in four NDAs.
The generic ingredient in PRIMAQUINE is primaquine phosphate. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the primaquine phosphate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Primaquine
A generic version of PRIMAQUINE was approved as primaquine phosphate by BAYSHORE PHARMS LLC on February 25th, 2014.
Summary for PRIMAQUINE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 132 |
| Patent Applications: | 3,961 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PRIMAQUINE |
| DailyMed Link: | PRIMAQUINE at DailyMed |
Recent Clinical Trials for PRIMAQUINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shoklo Malaria Research Unit | Phase 4 |
| Syamsudin Abdillah,Ph.D, Pharm D | Phase 2 |
| Centre Hospitalier de Cayenne | N/A |
Pharmacology for PRIMAQUINE
| Drug Class | Antimalarial |
Anatomical Therapeutic Chemical (ATC) Classes for PRIMAQUINE
US Patents and Regulatory Information for PRIMAQUINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | PRIMAQUINE | primaquine phosphate | TABLET;ORAL | 008316-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novast Labs | PRIMAQUINE PHOSPHATE | primaquine phosphate | TABLET;ORAL | 206043-001 | Jun 23, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alvogen | PRIMAQUINE PHOSPHATE | primaquine phosphate | TABLET;ORAL | 203924-001 | Feb 3, 2014 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bayshore Pharms Llc | PRIMAQUINE PHOSPHATE | primaquine phosphate | TABLET;ORAL | 204476-001 | Feb 25, 2014 | 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 |
