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Generated: September 23, 2017
What is the patent landscape for Suboxone, and when can generic versions of Suboxone launch?
Suboxone is a drug marketed by Indivior Inc and is included in two NDAs. There are four patents protecting this drug and three Paragraph IV challenges.| Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 5 |
| Clinical Trials: see list | 58 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | SUBOXONE at DailyMed |
| Drug Class | Partial Opioid Agonist Opioid Antagonist |
| Mechanism of Action | Partial Opioid Agonists Opioid Antagonists |
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| buprenorphine hydrochloride and naloxone hydrochloride | Sulingual Film | 12 mg/3 mg | Suboxone | 3/26/2014 |
| buprenorphine hydrochloride and naloxone hydrochloride | Sublingual Film | 2 mg/0.5 mg and 8 mg/2 mg | Suboxone | 10/15/2012 |
| buprenorphine hydrochloride and naloxone hydrochloride | Sublingual Film | 4 mg/1 mg | Suboxone | 5/14/2013 |
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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,685,437 | Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom | ► Subscribe | |||||||||||||
| 8,765,167 | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions | ► Subscribe | |||||||||||||
| 9,108,340 | Process for manufacturing a resulting multi-layer pharmaceutical film | ► Subscribe | |||||||||||||
| 2,016,206,639 | ► Subscribe | ||||||||||||||
| 7,824,588 | Method of making self-supporting therapeutic active-containing film | ► Subscribe | |||||||||||||
| 7,666,337 | Polyethylene oxide-based films and drug delivery systems made therefrom | ► Subscribe | |||||||||||||
| 8,900,497 | Process for making a film having a substantially uniform distribution of components | ► Subscribe | |||||||||||||
| 7,425,292 | Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom | ► Subscribe | |||||||||||||
| 8,906,277 | Process for manufacturing a resulting pharmaceutical film | ► Subscribe | |||||||||||||
| 8,663,687 | Film compositions for delivery of actives | ► 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2473967 | ► Subscribe | |||||||||||||
| Japan | 5819827 | ► Subscribe | |||||||||||||
| Japan | 2005528328 | ► Subscribe | |||||||||||||
| European Patent Office | 1799453 | ► Subscribe | |||||||||||||
| Japan | 4879458 | ► Subscribe | |||||||||||||
| Japan | 5165888 | ► Subscribe | |||||||||||||
| Japan | 2011140507 | ► Subscribe | |||||||||||||
| Brazil | PI0410956 | ► Subscribe | |||||||||||||
| Japan | 5538905 | ► Subscribe | |||||||||||||
| Austria | 536869 | ► Subscribe | |||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
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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