ZENATANE Drug Patent Profile
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Which patents cover Zenatane, and what generic alternatives are available?
Zenatane is a drug marketed by Dr Reddys Labs Ltd and is included in one NDA.
The generic ingredient in ZENATANE 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 Zenatane
A generic version of ZENATANE was approved as isotretinoin by AMNEAL PHARMS NY on September 29th, 2017.
Summary for ZENATANE
Recent Clinical Trials for ZENATANE
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 ZENATANE
| Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for ZENATANE
US Patents and Regulatory Information for ZENATANE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Ltd | ZENATANE | isotretinoin | CAPSULE;ORAL | 202099-001 | Mar 25, 2013 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys Labs Ltd | ZENATANE | isotretinoin | CAPSULE;ORAL | 202099-003 | Mar 25, 2013 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys Labs Ltd | ZENATANE | isotretinoin | CAPSULE;ORAL | 202099-002 | Mar 25, 2013 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys Labs Ltd | ZENATANE | isotretinoin | CAPSULE;ORAL | 202099-004 | Feb 23, 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 |
