METHADONE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for methadone hydrochloride and what is the scope of freedom to operate?
Methadone hydrochloride
is the generic ingredient in five branded drugs marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Sandoz, Ascent Pharms Inc, Aurolife Pharma Llc, Epic Pharma Llc, Nostrum Labs Inc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for methadone hydrochloride. Eighteen suppliers are listed for this compound.
Summary for METHADONE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 15 |
NDAs: | 33 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 18 |
Raw Ingredient (Bulk) Api Vendors: | 29 |
Clinical Trials: | 369 |
Patent Applications: | 7,810 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for METHADONE HYDROCHLORIDE |
What excipients (inactive ingredients) are in METHADONE HYDROCHLORIDE? | METHADONE HYDROCHLORIDE excipients list |
DailyMed Link: | METHADONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for METHADONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Phase 2 |
Parnassia Addiction Research Centre | Phase 2 |
Leiden University Medical Center | Phase 2 |
Pharmacology for METHADONE HYDROCHLORIDE
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for METHADONE HYDROCHLORIDE
US Patents and Regulatory Information for METHADONE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Roxane | METHADONE HYDROCHLORIDE | methadone hydrochloride | TABLET;ORAL | 074081-001 | Apr 28, 1995 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | DOLOPHINE HYDROCHLORIDE | methadone hydrochloride | TABLET;ORAL | 006134-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Vistapharm | METHADONE HYDROCHLORIDE | methadone hydrochloride | TABLET;ORAL | 040241-002 | May 29, 1998 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mallinckrodt Inc | METHADONE HYDROCHLORIDE | methadone hydrochloride | POWDER;FOR RX COMPOUNDING | 006383-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan Institutional | METHADONE HYDROCHLORIDE | methadone hydrochloride | INJECTABLE;INJECTION | 021624-001 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ 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 |
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