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AMERGE Drug Profile
» See Plans and Pricing
When do Amerge patents expire, and when can generic versions of Amerge launch?
Amerge is a drug marketed by Glaxosmithkline Llc and is included in one NDA.
The generic ingredient in AMERGE is naratriptan hydrochloride. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.
Summary for AMERGE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 89 |
| Clinical Trials: | 4 |
| Patent Applications: | 422 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AMERGE |
| DailyMed Link: | AMERGE at DailyMed |
Recent Clinical Trials for AMERGE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hartford HealthCare | Phase 1/Phase 2 |
| GlaxoSmithKline | N/A |
| GlaxoSmithKline | Phase 4 |
Pharmacology for AMERGE
| Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
US Patents and Regulatory Information for AMERGE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | AMERGE | naratriptan hydrochloride | TABLET;ORAL | 020763-002 | Feb 10, 1998 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Glaxosmithkline Llc | AMERGE | naratriptan hydrochloride | TABLET;ORAL | 020763-001 | Feb 10, 1998 | AB | RX | Yes | Yes | 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 |
Expired US Patents for AMERGE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | AMERGE | naratriptan hydrochloride | TABLET;ORAL | 020763-002 | Feb 10, 1998 | Start Trial | Start Trial |
| Glaxosmithkline Llc | AMERGE | naratriptan hydrochloride | TABLET;ORAL | 020763-001 | Feb 10, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMERGE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| United Kingdom | 8719167 | Start Trial |
| European Patent Office | 0303506 | Start Trial |
| Czech Republic | 9104042 | Start Trial |
| Singapore | 65393 | Start Trial |
| Germany | 19775082 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AMERGE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0303507 | 97C0102 | Belgium | Start Trial | PRODUCT NAME: NARATRIPTAN HYDROCHLORIDUM; REGISTRATION NO/DATE: 725 IS 278 F 3 19970818; FIRST REGISTRATION: SE 13382 19970310 |
| 0303507 | 64/1997 | Austria | Start Trial | PRODUCT NAME: ''NARATRIPTAN'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATES EINSCHLIESSLICH DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-22059 19970731; FIRST REGISTRATION: SE 13382 19970310 |
| 0303507 | C970035 | Netherlands | Start Trial | PRODUCT NAME: NARATRIPTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAA RDBAAR ZOUT OF SOLVAAT, IN HET BIJZONDER NARATRIPTAN-HYDROCHLOR IDE; NAT. REGISTRATION NO/DATE: RVG 21444 19970801; FIRST REGISTRATION: SE 13382 19970310 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
