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Generated: September 26, 2017
What are the generic drug sources for oxycodone hydrochloride and what is the scope of oxycodone hydrochloride freedom to operate?
Oxycodone hydrochloride is the generic ingredient in five branded drugs marketed by Novel Labs Inc, Mayne Pharma Inc, West-ward Pharms Int, Wes Pharma Inc, Mallinckrodt Inc, Vintage Pharms, Alvogen Malta, Hi-tech Pharmacal, Ascent Pharms Inc, Ken Lifescience, Pharm Assoc, Lannett Holdings Inc, Roxane, Lehigh Valley, Actavis Elizabeth, Vistapharm, Amneal Pharms, Ani Pharms Inc, Wockhardt Bio Ag, Sun Pharm Inds Inc, Aurolife Pharma Llc, Epic Pharma Llc, Purdue Pharma Lp, Avanthi Inc, Daiichi Sankyo Inc, Egalet Us Inc, Nesher Pharms, Rhodes Pharms, and Abhai Llc, and is included in forty-four NDAs. There are twenty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 5 |
| Patents: | 24 |
| Applicants: | 29 |
| NDAs: | 44 |
| Drug Master File Entries: see list | 17 |
| Suppliers / Packagers: see list | 59 |
| Bulk Api Vendors: see list | 24 |
| Clinical Trials: see list | 2,554 |
| Patent Applications: see list | 6,391 |
| Therapeutic Class: | Analgesics |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | oxycodone hydrochloride at DailyMed |
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 80MG | TABLET, EXTENDED RELEASE; ORAL |
| ► Subscribe | ► Subscribe | 80MG | TABLET, EXTENDED RELEASE; ORAL |
| ► Subscribe | ► Subscribe | 40MG | TABLET, EXTENDED RELEASE; ORAL |
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,337,888 | Pharmaceutical formulation containing gelling agent | ► Subscribe | |||||||||||||
| 8,017,148 | Pharmaceutical formulation containing opioid agonist, opioid antagonist and irritant agent | ► Subscribe | |||||||||||||
| 8,192,722 | Abuse-proof dosage form | ► Subscribe | |||||||||||||
| 9,387,174 | Pharmaceutical formulation containing gelling agent | ► Subscribe | |||||||||||||
| 9,561,225 | Pharmaceutical formulation containing opioid agonist, opioid antagonist and gelling agent | ► Subscribe | |||||||||||||
| 8,652,515 | Pharmaceutical formulation containing an opioid agonist, opioid antagonist and irritant agent | ► Subscribe | |||||||||||||
| 9,040,084 | Pharmaceutical formulation containing gelling agent | ► Subscribe | |||||||||||||
| 9,492,390 | Tamper resistant dosage forms | ► Subscribe | |||||||||||||
| 9,757,341 | Pharmaceutical formulation containing gelling agent | ► Subscribe | |||||||||||||
| 8,911,719 | Tamper resistant dosage forms | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2005534664 | ► Subscribe | |||||||||||||
| European Patent Office | 1014941 | ► Subscribe | |||||||||||||
| Cyprus | 1114104 | ► Subscribe | |||||||||||||
| Japan | 2017125052 | ► Subscribe | |||||||||||||
| Australia | 2015200009 | ► Subscribe | |||||||||||||
| China | 1960994 | ► Subscribe | |||||||||||||
| Slovenia | EP2305683 | ► Subscribe | |||||||||||||
| Germany | 502004010368 | ► Subscribe | |||||||||||||
| Portugal | 2311459 | ► Subscribe | |||||||||||||
| Japan | 2012229249 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 292 | Luxembourg | ► Subscribe | 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 | ||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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