Details for New Drug Application (NDA): 022410
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NDA 022410 describes SUBOXONE, which is a drug marketed by Indivior and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the SUBOXONE profile page.
The generic ingredient in SUBOXONE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
The generic ingredient in SUBOXONE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 022410
| Tradename: | SUBOXONE |
| Applicant: | Indivior |
| Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
| Patents: | 3 |
Pharmacology for NDA: 022410
| Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Suppliers and Packaging for NDA: 022410
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410 | NDA | INDIVIOR INC. | 12496-1202 | 12496-1202-3 | 30 POUCH in 1 CARTON (12496-1202-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1) |
| SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410 | NDA | INDIVIOR INC. | 12496-1204 | 12496-1204-3 | 30 POUCH in 1 CARTON (12496-1204-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1204-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL, SUBLINGUAL | Strength | EQ 2MG BASE;EQ 0.5MG BASE | ||||
| Approval Date: | Aug 30, 2010 | TE: | AB | RLD: | Yes | ||||
| Patent: | 11,135,216 | Patent Expiration: | Aug 7, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATING OPIOID USE DISORDER | ||||||||
| Patent: | 8,475,832 | Patent Expiration: | Mar 26, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE | ||||||||
| Patent: | 9,687,454 | Patent Expiration: | Aug 7, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION | ||||||||
Expired US Patents for NDA 022410
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Indivior | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-003 | Aug 10, 2012 | 9,855,221 | ⤷ Get Started Free |
| Indivior | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-003 | Aug 10, 2012 | 8,017,150 | ⤷ Get Started Free |
| Indivior | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-004 | Aug 10, 2012 | 8,017,150 | ⤷ Get Started Free |
| Indivior | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-002 | Aug 30, 2010 | 9,931,305 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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