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Generated: May 29, 2017
What are the generic sources for buprenorphine and what is the scope of buprenorphine patent protection?
Buprenorphine is the generic ingredient in ten branded drugs marketed by Purdue Pharma Lp, Indivior Inc, Actavis Elizabeth, Ethypharm, Luitpold, West-ward Pharms Int, Bdsi, Hospira, Braeburn Pharms Inc, Barr, Sun Pharm Inds Ltd, Mylan Pharms Inc, Rhodes Pharms, Sandoz Inc, Par Sterile Products, Kremers Urban Pharms, Ethypharm Usa Corp, Amneal Pharms, Orexo Us Inc, and Teva Pharms Usa, and is included in twenty-eight NDAs. There are twenty patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 10 |
| Patents: | 20 |
| Applicants: | 20 |
| NDAs: | 28 |
| Drug Master File Entries: see list | 28 |
| Suppliers / Packagers: see list | 3 |
| Bulk Api Vendors: see list | 9 |
| Clinical Trials: see list | 139 |
| Patent Applications: see list | 12,948 |
| Therapeutic Class: | Analgesics |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | buprenorphine at DailyMed |
| Drug Class | Partial Opioid Agonist |
| Mechanism of Action | Partial Opioid Agonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | RX | Yes | Yes | 8,147,866 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-004 | Dec 11, 2014 | RX | Yes | Yes | 9,439,900 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-002 | Aug 30, 2010 | RX | Yes | No | 8,475,832 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | RX | Yes | No | 8,147,866 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-005 | Jun 30, 2014 | RX | Yes | No | RE41408 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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Paragraph IV Activity
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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 verifification 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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