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OXYCONTIN Drug Profile
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Which patents cover Oxycontin, and when can generic versions of Oxycontin launch?
Oxycontin is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are twenty-three patents protecting this drug and seven Paragraph IV challenges.
This drug has five hundred and sixty-two patent family members in forty-eight countries.
The generic ingredient in OXYCONTIN is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Oxycontin
A generic version of OXYCONTIN was approved as oxycodone hydrochloride by ACTAVIS ELIZABETH on February 6th, 2004.
Summary for OXYCONTIN
| International Patents: | 562 |
| US Patents: | 23 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 7 |
| Bulk Api Vendors: | 19 |
| Clinical Trials: | 53 |
| Patent Applications: | 4,413 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OXYCONTIN |
| Drug Sales Revenues: | Drug sales revenues for OXYCONTIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OXYCONTIN |
| DailyMed Link: | OXYCONTIN at DailyMed |
Recent Clinical Trials for OXYCONTIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Karolinska Institutet | Phase 3 |
| Khashayar Vaziri | Phase 2 |
| Chinese University of Hong Kong | N/A |
Pharmacology for OXYCONTIN
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
US Patents and Regulatory Information for OXYCONTIN
| 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 | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-004 | Apr 5, 2010 | RX | Yes | No | Start Trial | Start Trial | Y | 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 | |||
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-002 | Apr 5, 2010 | RX | Yes | No | Start Trial | Start Trial | 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 OXYCONTIN
| 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 | 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 | 022272-003 | Apr 5, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OXYCONTIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69739343 | Start Trial |
| Poland | 1699440 | Start Trial |
| Chile | 2017000669 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OXYCONTIN
| 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 |
