Buprenorphine hydrochloride - Generic Drug Details
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What are the generic drug sources for buprenorphine hydrochloride and what is the scope of freedom to operate?
Buprenorphine hydrochloride
is the generic ingredient in ten branded drugs marketed by Bdsi, Alvogen, Titan Pharms, Indivior, Am Regent, Hikma, Hospira, Par Sterile Products, Actavis Elizabeth, Barr, Ethypharm, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, Aveva, Dr Reddys Labs Sa, Mylan Technologies, Teva Pharms Usa, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Wes Pharma Inc, and Orexo Us Inc, and is included in forty NDAs. There are twenty patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Buprenorphine hydrochloride has ninety-two patent family members in twenty-eight countries.
There are sixteen drug master file entries for buprenorphine hydrochloride. Twenty suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for buprenorphine hydrochloride
| International Patents: | 92 |
| US Patents: | 20 |
| Tradenames: | 10 |
| Applicants: | 26 |
| NDAs: | 40 |
| Drug Master File Entries: | 16 |
| Finished Product Suppliers / Packagers: | 20 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 490 |
| Patent Applications: | 2 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for buprenorphine hydrochloride |
| What excipients (inactive ingredients) are in buprenorphine hydrochloride? | buprenorphine hydrochloride excipients list |
| DailyMed Link: | buprenorphine hydrochloride at DailyMed |
Recent Clinical Trials for buprenorphine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Gangnam Severance Hospital | N/A |
| Washington University School of Medicine | Phase 3 |
| Loyola University | Phase 4 |
Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL |
| ⤷ Try a Trial | ⤷ Try a Trial | EQ 0.7MG BASE;EQ 0.18MG BASE | TABLET;SUBLINGUAL |
| ⤷ Try a Trial | ⤷ Try a Trial | EQ 2.9MG BASE;EQ 0.71MG BASE | TABLET;SUBLINGUAL |
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 hydrochloride
| Drug Class | Partial Opioid Agonist |
| Mechanism of Action | Partial Opioid Agonists |
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BELBUCA | Buccal Film | buprenorphine hydrochloride | 75 mcg and 150 mcg | 207932 | 1 | 2016-10-24 |
| BELBUCA | Buccal Film | buprenorphine hydrochloride | 300 mcg, 450 mcg, 600 mcg and 750 mcg | 207932 | 1 | 2016-10-04 |
| BELBUCA | Buccal Film | buprenorphine hydrochloride | 900 mcg | 207932 | 1 | 2016-09-12 |
US Patents and Regulatory Information for buprenorphine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indivior | SUBUTEX | buprenorphine hydrochloride | TABLET;SUBLINGUAL | 020732-002 | Oct 8, 2002 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-001 | Jul 3, 2013 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Hikma | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 203326-001 | Jun 27, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-002 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for buprenorphine hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 5448814 | ⤷ Try a Trial | |
| Japan | 6255349 | ⤷ Try a Trial | |
| Ukraine | 118540 | ПРИСТРОЇ ДЛЯ ТРАНСМУКОЗАЛЬНОЇ ДОСТАВКИ ЛІКІВ ДЛЯ ЗАСТОСУВАННЯ У ПОЛЕГШЕННІ ХРОНІЧНОГО БОЛЮ (TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF) | ⤷ Try a Trial |
| >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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