BUTRANS Drug Patent Profile
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When do Butrans patents expire, and what generic alternatives are available?
Butrans is a drug marketed by Purdue Pharma Lp and is included in one NDA.
The generic ingredient in BUTRANS is buprenorphine. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Butrans
A generic version of BUTRANS was approved as buprenorphine by WATSON LABS TEVA on November 20th, 2018.
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Summary for BUTRANS
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 19 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,976 |
| Drug Prices: | Drug price information for BUTRANS |
| Drug Sales Revenues: | Drug sales revenues for BUTRANS |
| What excipients (inactive ingredients) are in BUTRANS? | BUTRANS excipients list |
| DailyMed Link: | BUTRANS at DailyMed |
Recent Clinical Trials for BUTRANS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Massachusetts General Hospital | Phase 4 |
| Purdue Pharma LP | Phase 1 |
| Purdue Pharma LP | Phase 2 |
Pharmacology for BUTRANS
| Drug Class | Partial Opioid Agonist |
| Mechanism of Action | Partial Opioid Agonists |
Paragraph IV (Patent) Challenges for BUTRANS
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BUTRANS | Transdermal System | buprenorphine | 15 mcg/hr | 021306 | 1 | 2013-12-16 |
| BUTRANS | Transdermal System | buprenorphine | 5 mcg/hr 10 mcg/hr 20 mcg/hr | 021306 | 1 | 2013-06-06 |
US Patents and Regulatory Information for BUTRANS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-001 | Jun 30, 2010 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-004 | Jul 25, 2013 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-005 | Jun 30, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-002 | Jun 30, 2010 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-003 | Jun 30, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 BUTRANS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-003 | Jun 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-002 | Jun 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-005 | Jun 30, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-003 | Jun 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-005 | Jun 30, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-001 | Jun 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BUTRANS
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A. | Sixmo | buprenorphine | EMEA/H/C/004743 Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment. |
Authorised | no | no | no | 2019-06-19 | |
| Camurus AB | Buvidal | buprenorphine | EMEA/H/C/004651 Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over. |
Authorised | no | no | no | 2018-11-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for BUTRANS
See the table below for patents covering BUTRANS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2301494 | ⤷ Sign Up | |
| European Patent Office | 2305194 | Un timbre transdermique comprenant de la buprenorphine pour son utilisation dans le traitement de la douleur pour un interval de dosage d'au moins 7 jours (A buprenorphine transdermal patch for use in the treatment of pain for a dosing interval of at least 7 days) | ⤷ Sign Up |
| European Patent Office | 1570823 | Un timbre transdermique comprenant de la buprenorphine pour son utilisation dans le traitement de la douleur pour un interval de dosage d'au moins 4 jours (A buprenorphine transdermal patch for use in the treatment of pain for a dosing interval of at least 4 days) | ⤷ Sign Up |
| Israel | 201437 | TRANSDERMAL DELIVERY SYSTEMS OF BUPRENORPHINE FOR USE IN TREATING PAIN | ⤷ Sign Up |
| Japan | H10512551 | ⤷ Sign Up | |
| European Patent Office | 0430019 | Système thérapeutique transdermique contenant de la buprénorphine comme composant actif (Transdermal therapeutic system containing buprenorphine as an active component) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >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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