Details for New Drug Application (NDA): 022272
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NDA 022272 describes OXYCONTIN, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from three suppliers. There are eighteen patents protecting this drug and seven Paragraph IV challenges. Additional details are available on the OXYCONTIN profile page.
The generic ingredient in OXYCONTIN is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
The generic ingredient in OXYCONTIN is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
Summary for 022272
| Tradename: | OXYCONTIN |
| Applicant: | Purdue Pharma Lp |
| Ingredient: | oxycodone hydrochloride |
| Patents: | 18 |
Pharmacology for NDA: 022272
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 022272
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-5731 | 0093-5731-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-5731-01) |
| OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-5732 | 0093-5732-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-5732-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 5, 2010 | TE: | RLD: | Yes | |||||
| Patent: | 10,407,434 | Patent Expiration: | Mar 30, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 10,696,684 | Patent Expiration: | Mar 30, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 11,304,908 | Patent Expiration: | Aug 24, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022272
| 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 | 10,369,109 | ⤷ Subscribe |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-004 | Apr 5, 2010 | 6,488,963 | ⤷ Subscribe |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-007 | Apr 5, 2010 | 10,675,278 | ⤷ Subscribe |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-005 | Apr 5, 2010 | 9,675,610 | ⤷ Subscribe |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-003 | Apr 5, 2010 | 9,675,610 | ⤷ Subscribe |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-001 | Apr 5, 2010 | 9,675,610 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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