Details for New Drug Application (NDA): 204242
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NDA 204242 describes ZUBSOLV, which is a drug marketed by Orexo Us Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug and four Paragraph IV challenges. Additional details are available on the ZUBSOLV profile page.
The generic ingredient in ZUBSOLV 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 ZUBSOLV 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 204242
| Tradename: | ZUBSOLV |
| Applicant: | Orexo Us Inc |
| Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
| Patents: | 10 |
Pharmacology for NDA: 204242
| Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Suppliers and Packaging for NDA: 204242
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242 | NDA | Orexo US, Inc. | 54123-114 | 54123-114-30 | 3 BLISTER PACK in 1 CARTON (54123-114-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242 | NDA | Orexo US, Inc. | 54123-907 | 54123-907-30 | 3 BLISTER PACK in 1 CARTON (54123-907-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 1.4MG BASE;EQ 0.36MG BASE | ||||
| Approval Date: | Jul 3, 2013 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 18, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 18, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 18, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE | ||||||||
Expired US Patents for NDA 204242
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-005 | Jun 4, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-006 | Oct 4, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-002 | Jul 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-001 | Jul 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-003 | Dec 11, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-004 | Dec 11, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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