Buprenorphine hydrochloride; naloxone hydrochloride - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for buprenorphine hydrochloride; naloxone hydrochloride and what is the scope of patent protection?
Buprenorphine hydrochloride; naloxone hydrochloride
is the generic ingredient in five branded drugs marketed by Bdsi, Alvogen, Aveva, Dr Reddys Labs Sa, Mylan Technologies, Indivior, Teva Pharms Usa, Actavis Elizabeth, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Wes Pharma Inc, and Orexo Us Inc, and is included in twenty-three NDAs. There are eighteen patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Buprenorphine hydrochloride; naloxone hydrochloride has three hundred and thirty-six patent family members in thirty-seven countries.
Twenty-four suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for buprenorphine hydrochloride; naloxone hydrochloride
International Patents: | 336 |
US Patents: | 18 |
Tradenames: | 5 |
Applicants: | 18 |
NDAs: | 23 |
Finished Product Suppliers / Packagers: | 24 |
Clinical Trials: | 130 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for buprenorphine hydrochloride; naloxone hydrochloride |
DailyMed Link: | buprenorphine hydrochloride; naloxone hydrochloride at DailyMed |
Recent Clinical Trials for buprenorphine hydrochloride; naloxone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bicycle Health | Phase 4 |
Royal Victoria Hospital, Canada | Phase 4 |
Wake Forest University Health Sciences | Phase 2 |
See all buprenorphine hydrochloride; naloxone hydrochloride clinical trials
Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL |
⤷ Try a Trial | ⤷ Try a Trial | EQ 0.7MG BASE;EQ 0.18MG BASE | TABLET;SUBLINGUAL |
⤷ Try a Trial | ⤷ Try a Trial | EQ 2.9MG BASE;EQ 0.71MG BASE | TABLET;SUBLINGUAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for buprenorphine hydrochloride; naloxone hydrochloride
Drug Class | Opioid Antagonist Partial Opioid Agonist |
Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US Patents and Regulatory Information for buprenorphine hydrochloride; naloxone hydrochloride
Expired US Patents for buprenorphine hydrochloride; naloxone hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Indivior | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-001 | Aug 30, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Indivior | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-002 | Aug 30, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Indivior | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-001 | Aug 30, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Indivior | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-003 | Aug 10, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for buprenorphine hydrochloride; naloxone hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2473970 | COUCHES MINCES UNIFORMES SERVANT A DISSOUDRE RAPIDEMENT UNE FORME GALENIQUE INCORPORANT DES COMPOSITIONS DE MASQUAGE DE GOUT (UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING COMPOSITIONS) | ⤷ Try a Trial |
Japan | 2017171687 | オピオイド依存を治療するための新規乱用耐性医薬組成物 (NEW ABUSE-RESISTANT PHARMACEUTICAL COMPOSITION FOR TREATMENT OF OPIOID DEPENDENCE) | ⤷ Try a Trial |
European Patent Office | 1407314 | REVETEMENTS INTERFERENTIELS A COUCHES MINCES, A INDICE ACCORDABLE (INDEX TUNABLE THIN FILM INTERFERENCE COATINGS) | ⤷ Try a Trial |
Japan | 2011050394 | MULTI-LAYER FILM HAVING UNIFORM CONTENT | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.