METHADOSE Drug Patent Profile
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Which patents cover Methadose, and what generic alternatives are available?
Methadose is a drug marketed by Specgx Llc and is included in three NDAs.
The generic ingredient in METHADOSE is methadone hydrochloride. There are thirteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Methadose
A generic version of METHADOSE was approved as methadone hydrochloride by ROXANE on March 8th, 1983.
Summary for METHADOSE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 30 |
| Clinical Trials: | 7 |
| Patent Applications: | 3,075 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for METHADOSE |
| What excipients (inactive ingredients) are in METHADOSE? | METHADOSE excipients list |
| DailyMed Link: | METHADOSE at DailyMed |
Recent Clinical Trials for METHADOSE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The Ottawa Hospital | Phase 3 |
| Bruyere Research Institute | Phase 3 |
| Ottawa Hospital Research Institute | Phase 3 |
Pharmacology for METHADOSE
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for METHADOSE
US Patents and Regulatory Information for METHADOSE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specgx Llc | METHADOSE | methadone hydrochloride | CONCENTRATE;ORAL | 017116-002 | Approved Prior to Jan 1, 1982 | AA | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Specgx Llc | METHADOSE | methadone hydrochloride | TABLET;ORAL | 040050-002 | Apr 15, 1993 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Specgx Llc | METHADOSE | methadone hydrochloride | TABLET, FOR SUSPENSION;ORAL | 074184-001 | Apr 29, 1993 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Specgx Llc | METHADOSE | methadone hydrochloride | TABLET;ORAL | 040050-001 | Apr 15, 1993 | DISCN | 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 |
