NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for naloxone hydrochloride; oxycodone hydrochloride and what is the scope of patent protection?
Naloxone hydrochloride; oxycodone hydrochloride
is the generic ingredient in one branded drug marketed by Purdue Pharma Lp and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Naloxone hydrochloride; oxycodone hydrochloride has one hundred and fifty-one patent family members in forty-one countries.
Summary for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
| International Patents: | 151 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 51 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE |
| DailyMed Link: | NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Murdoch Childrens Research Institute | Phase 4 |
| Ensysce Biosciences | Phase 1 |
| Dr. Vince Clinical Research | Phase 1 |
See all NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
US Patents and Regulatory Information for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-001 | Jul 23, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-003 | Jul 23, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-002 | Jul 23, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-001 | Jul 23, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-003 | Jul 23, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-002 | Jul 23, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-003 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-003 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-001 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-003 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-002 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-002 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-003 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | 201231469 | Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone and oxycodone hydrochloride composition, pharmaceutical dosage form, sustained release oral dosage form and pharmaceutically acceptable package having less than 25 | ⤷ Sign Up |
| Slovenia | 2305683 | ⤷ Sign Up | |
| South Korea | 20100069719 | PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE | ⤷ Sign Up |
| Spain | 2535618 | ⤷ Sign Up | |
| Malaysia | 154985 | OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE | ⤷ Sign Up |
| South Korea | 20140021716 | PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE | ⤷ Sign Up |
| Australia | 2013202453 | Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1685839 | 92292 | Luxembourg | ⤷ Sign Up | 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 |
