AMNESTEEM Drug Patent Profile
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Which patents cover Amnesteem, and what generic alternatives are available?
Amnesteem is a drug marketed by Mylan Pharms Inc and is included in one NDA.
The generic ingredient in AMNESTEEM is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amnesteem
A generic version of AMNESTEEM was approved as isotretinoin by AMNEAL PHARMS NY on September 29th, 2017.
Summary for AMNESTEEM
Recent Clinical Trials for AMNESTEEM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Oncology Group | Phase 2 |
| Dr. Reddy's Laboratories Limited | Phase 1 |
| Children's Oncology Group | N/A |
Pharmacology for AMNESTEEM
| Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for AMNESTEEM
US Patents and Regulatory Information for AMNESTEEM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Pharms Inc | AMNESTEEM | isotretinoin | CAPSULE;ORAL | 075945-001 | Nov 8, 2002 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan Pharms Inc | AMNESTEEM | isotretinoin | CAPSULE;ORAL | 075945-002 | Nov 8, 2002 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan Pharms Inc | AMNESTEEM | isotretinoin | CAPSULE;ORAL | 075945-003 | Nov 8, 2002 | AB1 | RX | 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 |
