Details for New Drug Application (NDA): 021306
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NDA 021306 describes BUTRANS, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from two suppliers. Additional details are available on the BUTRANS profile page.
The generic ingredient in BUTRANS is buprenorphine. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
The generic ingredient in BUTRANS is buprenorphine. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
Summary for 021306
| Tradename: | BUTRANS |
| Applicant: | Purdue Pharma Lp |
| Ingredient: | buprenorphine |
| Patents: | 0 |
Pharmacology for NDA: 021306
| Mechanism of Action | Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 021306
Suppliers and Packaging for NDA: 021306
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306 | NDA AUTHORIZED GENERIC | Rhodes Pharmaceuticals L.P. | 42858-353 | 42858-353-40 | 4 POUCH in 1 CARTON (42858-353-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH |
| BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306 | NDA AUTHORIZED GENERIC | Rhodes Pharmaceuticals L.P. | 42858-493 | 42858-493-40 | 4 POUCH in 1 CARTON (42858-493-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 5MCG/HR | ||||
| Approval Date: | Jun 30, 2010 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 10MCG/HR | ||||
| Approval Date: | Jun 30, 2010 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 20MCG/HR | ||||
| Approval Date: | Jun 30, 2010 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021306
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-002 | Jun 30, 2010 | 5,240,711 | ⤷ Start Trial |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-002 | Jun 30, 2010 | RE41489 | ⤷ Start Trial |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-003 | Jun 30, 2010 | 6,344,211 | ⤷ Start Trial |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-005 | Jun 30, 2014 | 9,642,850 | ⤷ Start Trial |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-001 | Jun 30, 2010 | 5,240,711 | ⤷ Start Trial |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-005 | Jun 30, 2014 | 6,264,980 | ⤷ Start Trial |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-004 | Jul 25, 2013 | 6,264,980 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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