ELAVIL Drug Patent Profile
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Which patents cover Elavil, and when can generic versions of Elavil launch?
Elavil is a drug marketed by Astrazeneca and is included in two NDAs.
The generic ingredient in ELAVIL is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Elavil
A generic version of ELAVIL was approved as amitriptyline hydrochloride by SUN PHARM INDS INC on July 14th, 1987.
Summary for ELAVIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 54 |
| Clinical Trials: | 11 |
| Patent Applications: | 1,941 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ELAVIL at DailyMed |
Recent Clinical Trials for ELAVIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Missouri, Kansas City | Phase 3 |
| National Institute of Neurological Disorders and Stroke (NINDS) | Phase 2 |
| National Center for Complementary and Integrative Health (NCCIH) | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ELAVIL
US Patents and Regulatory Information for ELAVIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | ELAVIL | amitriptyline hydrochloride | INJECTABLE;INJECTION | 012704-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | ELAVIL | amitriptyline hydrochloride | TABLET;ORAL | 012703-007 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | ELAVIL | amitriptyline hydrochloride | TABLET;ORAL | 012703-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
Expired US Patents for ELAVIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | ELAVIL | amitriptyline hydrochloride | TABLET;ORAL | 012703-007 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | ELAVIL | amitriptyline hydrochloride | TABLET;ORAL | 012703-003 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | ELAVIL | amitriptyline hydrochloride | TABLET;ORAL | 012703-004 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
