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Generated: June 27, 2017
What are the generic drug sources for buprenorphine hydrochloride and what is the scope of buprenorphine hydrochloride patent protection?
Buprenorphine hydrochloride is the generic ingredient in nine branded drugs marketed by 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-seven NDAs. There are seventeen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 9 |
| Patents: | 17 |
| Applicants: | 19 |
| NDAs: | 27 |
| Drug Master File Entries: see list | 28 |
| Suppliers / Packagers: see list | 21 |
| Bulk Api Vendors: see list | 21 |
| Clinical Trials: see list | 2,563 |
| Patent Applications: see list | 1,028 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | buprenorphine hydrochloride 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Elizabeth | BUPRENORPHINE HYDROCHLORIDE | buprenorphine hydrochloride | TABLET;SUBLINGUAL | 090819-001 | Feb 19, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-002 | Jun 6, 2014 | RX | Yes | No | 7,579,019 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 020733-001 | Oct 8, 2002 | DISCN | Yes | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-003 | Dec 11, 2014 | RX | Yes | No | 8,940,330 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Amneal Pharms | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 203136-001 | Feb 22, 2013 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | 6,159,498 | ► Subscribe | ||||||||||||||||||||||
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-002 | Oct 23, 2015 | 6,159,498 | ► Subscribe | ||||||||||||||||||||||
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | 6,159,498 | ► Subscribe | ||||||||||||||||||||||
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-007 | Oct 23, 2015 | 6,159,498 | ► Subscribe | ||||||||||||||||||||||
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-004 | Oct 23, 2015 | 6,159,498 | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,800,832 | Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces | ► Subscribe | |||||||||||||||||||||||||||
| 9,597,288 | Transmucosal delivery devices with enhanced uptake | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Austria | 288743 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 2054031 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2561860 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | PA04011875 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 973497 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ biopharmaceutical companies globally:
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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