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ULTRAM Drug Profile
When do Ultram patents expire, and when can generic versions of Ultram launch?
Ultram is a drug marketed by Janssen Pharms and Valeant Pharms and is included in two NDAs. There is one patent protecting this drug and three Paragraph IV challenges.
The generic ingredient in ULTRAM is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
Summary for ULTRAM
| US Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 15 |
| Clinical Trials: | 17 |
| Patent Applications: | 124 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ULTRAM |
| Drug Sales Revenues: | Drug sales revenues for ULTRAM |
| DailyMed Link: | ULTRAM at DailyMed |
Recent Clinical Trials for ULTRAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rush University Medical Center | Phase 3 |
| PRA Health Sciences | Phase 1 |
| DF/Net Rearch | Phase 1 |
Pharmacology for ULTRAM
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Synonyms for ULTRAM
| (1RS,2RS)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-cyclo-hexanol |
| (1RS,2RS)-2-dimethylaminomethyl-1-(3-methoxy-phenyl)-cyclohexanol |
| 1-(m-Methoxyphenyl)-2-(dimethylaminomethyl)cyclohexane-1-ol |
| 2-((Dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexan-1-ol |
| 2-(dimethylaminomethyl)-1-(3-methoxyphenyl)cyclohexan-1-ol |
| 2-[(DIMETHYLAMINO)METHYL]-1-(3-METHOXYPHENYL)CYCLOHEXAN-1-OL |
| 2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol |
| 2-Dimethylaminomethyl-1-(m-methoxyphenyl)cyclohexanol |
| 2914-77-4 |
| AC1L1KJ8 |
| AC1Q7AST |
| ACM2914774 |
| AKOS022507395 |
| AN-32783 |
| CHEBI:75722 |
| CHEMBL1237044 |
| COR0000099 |
| CTK4G2807 |
| Cyclohexanol, 2-(dimethylaminomethyl)-1-(m-methoxyphenyl)- |
| Cyclohexanol, 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)- |
| Cyclohexanol,2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)- |
| EINECS 220-831-4 |
| GTPL8286 |
| L000985 |
| LS-57112 |
| LS-57113 |
| LS-57114 |
| Maxitram |
| MCULE-1882520267 |
| SCHEMBL57496 |
| Tilodol |
| TVYLLZQTGLZFBW-UHFFFAOYSA-N |
Paragraph IV (Patent) Challenges for ULTRAM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ULTRAM | TABLET;ORAL | tramadol hydrochloride | 020281 |
US Patents and Regulatory Information for ULTRAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-002 | Mar 3, 1995 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-002 | Sep 8, 2005 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-001 | Mar 3, 1995 | DISCN | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-001 | Sep 8, 2005 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-003 | Sep 8, 2005 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
