Buprenorphine hydrochloride - Generic Drug Details
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What are the generic drug sources for buprenorphine hydrochloride and what is the scope of patent protection?
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 1.4MG BASE;EQ 0.36MG BASE | TABLET;SUBLINGUAL |
⤷ Try a Trial | ⤷ Try a Trial | EQ 0.7MG BASE;EQ 0.18MG 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 |
Anatomical Therapeutic Chemical (ATC) Classes for buprenorphine hydrochloride
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
Expired US Patents for buprenorphine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-007 | 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 |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | 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 |
>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 | |
Mexico | 2009000745 | DISPOSITIVOS DE SUMINISTRO TRANSMUCOSA CON ADMISION MEJORADA. (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE.) | ⤷ Try a Trial |
Eurasian Patent Organization | 034529 | СПОСОБ ЛЕЧЕНИЯ ХРОНИЧЕСКОЙ БОЛИ У СУБЪЕКТА, ПРИНИМАВШЕГО ОПИОИДЫ, С ПРИМЕНЕНИЕМ ТРАНСМУКОЗАЛЬНОГО УСТРОЙСТВА ДЛЯ ДОСТАВКИ ЛЕКАРСТВ (METHOD OF TREATING CHRONIC PAIN IN AN OPIOID EXPERIENCED SUBJECT USING A TRANSMUCOSAL DRUG DELIVERY DEVICE) | ⤷ Try a Trial |
Australia | 2017258916 | Transmucosal drug delivery devices for use in chronic pain relief | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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