MYORISAN Drug Patent Profile
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Which patents cover Myorisan, and when can generic versions of Myorisan launch?
Myorisan is a drug marketed by Upsher Smith Labs and is included in one NDA.
The generic ingredient in MYORISAN 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 Myorisan
A generic version of MYORISAN was approved as isotretinoin by AMNEAL PHARMS NY on September 29th, 2017.
Summary for MYORISAN
Recent Clinical Trials for MYORISAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Oncology Group | Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
| National Cancer Institute (NCI) | Phase 1 |
Pharmacology for MYORISAN
| Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for MYORISAN
US Patents and Regulatory Information for MYORISAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Upsher Smith Labs | MYORISAN | isotretinoin | CAPSULE;ORAL | 076485-001 | Jan 19, 2012 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Upsher Smith Labs | MYORISAN | isotretinoin | CAPSULE;ORAL | 076485-003 | Jan 19, 2012 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Upsher Smith Labs | MYORISAN | isotretinoin | CAPSULE;ORAL | 076485-002 | Jan 19, 2012 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Upsher Smith Labs | MYORISAN | isotretinoin | CAPSULE;ORAL | 076485-004 | Aug 25, 2015 | 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 |
