METHADONE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Methadone Hydrochloride, and what generic alternatives are available?
Methadone Hydrochloride is a drug marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm Llc, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Vistapharm, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Epic Pharma Llc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc. and is included in twenty-eight NDAs.
The generic ingredient in METHADONE HYDROCHLORIDE is methadone hydrochloride. There are thirteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Methadone Hydrochloride
A generic version of METHADONE HYDROCHLORIDE was approved as methadone hydrochloride by ROXANE on March 8th, 1983.
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Questions you can ask:
- What is the 5 year forecast for METHADONE HYDROCHLORIDE?
- What are the global sales for METHADONE HYDROCHLORIDE?
- What is Average Wholesale Price for METHADONE HYDROCHLORIDE?
Summary for METHADONE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 15 |
| NDAs: | 28 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 29 |
| Clinical Trials: | 372 |
| Patent Applications: | 2,986 |
| Drug Prices: | Drug price information 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 |
|---|---|
| BC Centre on Substance Use | Phase 2 |
| Canadian Institutes of Health Research (CIHR) | Phase 2 |
| The University of Texas Health Science Center, Houston | Phase 4 |
Pharmacology for METHADONE HYDROCHLORIDE
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for METHADONE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specgx Llc | METHADONE HYDROCHLORIDE | methadone hydrochloride | TABLET;ORAL | 040517-002 | Apr 27, 2004 | AA | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Roxane | METHADONE HYDROCHLORIDE | methadone hydrochloride | TABLET;ORAL | 088108-001 | Mar 8, 1983 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm Industries | METHADONE HYDROCHLORIDE | methadone hydrochloride | TABLET;ORAL | 208305-001 | Mar 30, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roxane | METHADONE HYDROCHLORIDE | methadone hydrochloride | TABLET;ORAL | 088109-001 | Mar 8, 1983 | AA | RX | No | No | ⤷ 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 |
