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Oxycodone hydrochloride - Generic Drug Details
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This ingredient has four hundred and twenty-three patent family members in forty-four countries.
There are seventeen drug master file entries for oxycodone hydrochloride. Fifty-two suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for Generic Name: oxycodone hydrochloride
| Tradenames: | 4 |
| Patents: | 18 |
| Applicants: | 23 |
| NDAs: | 34 |
| Drug Master File Entries: see list | 17 |
| Suppliers / Packaging: see list | 52 |
| Therapeutic Class: | Analgesics |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: oxycodone hydrochloride
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Tentative approvals for OXYCODONE HYDROCHLORIDE
| Applicant | Application No. | Form | Dosage |
| <disabled> | <disabled> | TABLET, EXTENDED RELEASE; ORAL | 10MG |
| <disabled> | <disabled> | TABLET, EXTENDED RELEASE; ORAL | 20MG |
| <disabled> | <disabled> | TABLET, EXTENDED RELEASE; ORAL | 40MG |
Clinical Trials for: oxycodone hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mallinckrodt Inc | ROXICODONE | oxycodone hydrochloride | TABLET;ORAL | 021011-002 | Aug 31, 2000 | RX | No | ||||||||||||||||||||||
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-007 | Apr 5, 2010 | RX | No | 7,674,800 | Mar 30, 2025 | Y | |||||||||||||||||||
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-002 | Apr 5, 2010 | RX | No | Aug 13, 2018 | |||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: oxycodone hydrochloride
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-002 | Apr 5, 2010 | 5,508,042 | <disabled> | ||||||||||||||||||||||
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-003 | Apr 5, 2010 | 5,508,042 | <disabled> | ||||||||||||||||||||||
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-001 | Apr 5, 2010 | 5,508,042 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: oxycodone hydrochloride
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,652,497 | Pharmaceutical formulation containing irritant | <disabled in preview> | |||||||||||||||||||||||||||
| 8,192,722 | Abuse-proof dosage form | <disabled in preview> | |||||||||||||||||||||||||||
| 9,155,717 | Pharmaceutical formulation containing irritant | <disabled in preview> | |||||||||||||||||||||||||||
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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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International Patent Family for Ingredient: oxycodone hydrochloride
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 1014941 | <disabled in preview> | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 03013476 | <disabled in preview> | |||||||||||||||||||||||||||
| Argentina | 045353 | <disabled in preview> | |||||||||||||||||||||||||||
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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 Certificates for Tradename: OXYCODONE HYDROCHLORIDE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 292 | Luxembourg | <disabled> | 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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How are People Using DrugPatentWatch?
To find patent expirations in Russia
— Pharmaceutical company, Russia
For Information on historical patent expiration of small molecules by formulation
— Life science strategy consulting, USA
To get information about drug synthesis
— Chemical research, Spain
To get reliable data on drug patent information
— CFO, Pharmaceuticals, Singapore
To gain information on when to expect generics on the market in order to inform patients of when they can expect more affordable drugs
— Retail pharmacist, USA
To have rapid access to API suppliers, generic drug manufacturers, and patent information pertaining to any given drug product or drug substance.
— Pharmaceutical consulting, USA
For a comprehensive list of patents, along with their details, for some drug molecules
— Business analyst, India
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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