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Oxycodone hydrochloride - Generic Drug Details
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What are the generic sources for oxycodone hydrochloride and what is the scope of freedom to operate?
Oxycodone hydrochloride
is the generic ingredient in five branded drugs marketed by Ani Pharms Inc, Avanthi Inc, Genus Lifesciences, Lannett Co Inc, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Akorn, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Eywa, Hikma, Pharm Assoc, Rhodes Pharms, Specgx Llc, Vistapharm, Wockhardt Bio Ag, Purdue Pharma Lp, Roxane, Zyla, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Sun Pharm Inds Inc, Vintage Pharms, and Ohemo Life, and is included in fifty-one NDAs. There are thirty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Oxycodone hydrochloride has five hundred and ninety-eight patent family members in forty-eight countries.
There are nineteen drug master file entries for oxycodone hydrochloride. Forty-one suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for oxycodone hydrochloride
| International Patents: | 598 |
| US Patents: | 31 |
| Tradenames: | 5 |
| Applicants: | 30 |
| NDAs: | 51 |
| Drug Master File Entries: | 19 |
| Suppliers / Packagers: | 41 |
| Bulk Api Vendors: | 19 |
| Clinical Trials: | 478 |
| Patent Applications: | 5,434 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for oxycodone hydrochloride |
| DailyMed Link: | oxycodone hydrochloride at DailyMed |
Recent Clinical Trials for oxycodone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Oklahoma | Early Phase 1 |
| Washington University School of Medicine | N/A |
| NYU Langone Health | Phase 4 |
Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 80MG | TABLET, EXTENDED RELEASE; ORAL |
| Start Trial | Start Trial | 80MG | TABLET, EXTENDED RELEASE; ORAL |
| Start Trial | Start Trial | 40MG | TABLET, EXTENDED RELEASE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for oxycodone hydrochloride
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Paragraph IV (Patent) Challenges for OXYCODONE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OXAYDO | TABLET;ORAL | oxycodone hydrochloride | 202080 |
US Patents and Regulatory Information for oxycodone hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma Inc | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | TABLET;ORAL | 091313-004 | Apr 29, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Specgx Llc | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 210758-002 | Apr 30, 2018 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Ohemo Life | ROXYBOND | oxycodone hydrochloride | TABLET;ORAL | 209777-003 | Apr 20, 2017 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-005 | Apr 5, 2010 | RX | Yes | Yes | 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 |
Expired US Patents for oxycodone hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-005 | Apr 5, 2010 | Start Trial | Start Trial |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-004 | Apr 5, 2010 | Start Trial | Start Trial |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-001 | Apr 5, 2010 | Start Trial | Start Trial |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-007 | Apr 5, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for oxycodone hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20200000499 | Start Trial |
| Israel | 213889 | Start Trial |
| Slovenia | 2343071 | Start Trial |
| Malaysia | 154985 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for oxycodone hydrochloride
| 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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