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Buprenorphine - Generic Drug Details
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What are the generic sources for buprenorphine and what is the scope of freedom to operate?
Buprenorphine
is the generic ingredient in thirteen branded drugs marketed by Amneal, Watson Labs Teva, Purdue Pharma Lp, Indivior Inc, Bdsi, Titan Pharms, Am Regent, Hospira, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Barr, Ethypharm, Hikma, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, Alvogen Pine Brook, Dr Reddys Labs Sa, Mylan Technologies, Teva Pharms Usa, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Mayne Pharma Inc, Specgx Llc, Wes Pharma Inc, and Orexo Us Inc, and is included in forty-one NDAs. There are twenty-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Buprenorphine has forty-four patent family members in twenty-eight countries.
There are twenty-nine drug master file entries for buprenorphine. Six suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for buprenorphine
| International Patents: | 44 |
| US Patents: | 29 |
| Tradenames: | 13 |
| Applicants: | 29 |
| NDAs: | 41 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 9 |
| Clinical Trials: | 432 |
| Patent Applications: | 6,917 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for buprenorphine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for buprenorphine |
| What excipients (inactive ingredients) are in buprenorphine? | buprenorphine excipients list |
| DailyMed Link: | buprenorphine at DailyMed |
Recent Clinical Trials for buprenorphine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Centre Hospitalier Universitaire de Nīmes | Phase 3 |
| VA Connecticut Healthcare System | Early Phase 1 |
| The Wistar Institute | Phase 2 |
Generic filers with tentative approvals for BUPRENORPHINE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL |
| Start Trial | Start Trial | 8MG | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS |
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
| Drug Class | Partial Opioid Agonist |
| Mechanism of Action | Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for buprenorphine
Paragraph IV (Patent) Challenges for BUPRENORPHINE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BUTRANS | FILM, EXTENDED RELEASE;TRANSDERMAL | buprenorphine | 021306 | 2013-12-16 |
| BUTRANS | FILM, EXTENDED RELEASE;TRANSDERMAL | buprenorphine | 021306 | 2013-06-06 |
US Patents and Regulatory Information for buprenorphine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-003 | Dec 11, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Ethypharm | BUPRENORPHINE HYDROCHLORIDE | buprenorphine hydrochloride | TABLET;SUBLINGUAL | 090622-002 | Sep 24, 2010 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-002 | Jun 6, 2014 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-003 | Aug 10, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for buprenorphine
| 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 | Start Trial | Start Trial |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-003 | Jun 30, 2010 | Start Trial | Start Trial |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-002 | Jun 30, 2010 | Start Trial | Start Trial |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-005 | Jun 30, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for buprenorphine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Chile | 2012003462 | Start Trial |
| Poland | 2579874 | Start Trial |
| Hungary | E038275 | Start Trial |
| European Patent Office | 2579874 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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.
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