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OXAYDO Drug Profile
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When do Oxaydo patents expire, and what generic alternatives are available?
Oxaydo is a drug marketed by Zyla and is included in one NDA. There are six patents protecting this drug.
This drug has thirteen patent family members in six countries.
The generic ingredient in OXAYDO is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Oxaydo
A generic version of OXAYDO was approved as oxycodone hydrochloride by ACTAVIS ELIZABETH on January 20th, 2020.
Summary for OXAYDO
| International Patents: | 13 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 8 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OXAYDO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OXAYDO |
| DailyMed Link: | OXAYDO at DailyMed |
Recent Litigation for OXAYDO
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Purdue Pharma L.P. v. Amneal Pharmaceuticals, LLC | 2013-05-17 |
| Purdue Pharma L.P. v. Impax Laboratories, Inc. | 2013-05-10 |
| Acura Pharmaceuticals Inc. v. Ranbaxy Inc. | 2013-04-29 |
Pharmacology for OXAYDO
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Synonyms for OXAYDO
| (4R,4aS,7aR,12bS)-4a-hydroxy-9-methoxy-1,2,3,4,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride |
| 4,5-Epoxy-14-hydroxy-3-methoxy-17-methyl-morphinan-6-one, hydrochloride, (5-alpha)- (9CI) |
| 4,5alpha-Epoxy-14-hydroxy-3-methoxymorphinan-6-one Hydrochloride (Noroxycodone Hydrochloride) |
| 52446-25-0 |
| Dinarkon |
| Noroxycodone Hydrochloride |
| Noroxycodone Hydrochloride 1.0 mg/ml in Methanol (as free base) |
| Noroxycodone hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material |
| Oxecta |
| Oxycodone hydrochloride [USAN:USP:JAN] |
| Oxycodone XR |
| Rexista |
US Patents and Regulatory Information for OXAYDO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-001 | Jun 17, 2011 | RX | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-002 | Jun 17, 2011 | RX | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-001 | Jun 17, 2011 | RX | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-002 | Jun 17, 2011 | RX | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-002 | Jun 17, 2011 | RX | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-001 | Jun 17, 2011 | RX | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for OXAYDO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2005053587 | Start Trial |
| Australia | 2017239544 | Start Trial |
| Australia | 2010200979 | Start Trial |
| European Patent Office | 2402004 | Start Trial |
| Australia | 2015264950 | Start Trial |
| Spain | 2637338 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OXAYDO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1685839 | 92292 | Luxembourg | Start Trial | PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
