TRETINOIN MICROSPHERE Drug Patent Profile
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When do Tretinoin Microsphere patents expire, and when can generic versions of Tretinoin Microsphere launch?
Tretinoin Microsphere is a drug marketed by Encube and is included in one NDA.
The generic ingredient in TRETINOIN MICROSPHERE is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tretinoin Microsphere
A generic version of TRETINOIN MICROSPHERE was approved as tretinoin by PADAGIS US on December 24th, 1998.
Summary for TRETINOIN MICROSPHERE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 6 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | TRETINOIN MICROSPHERE at DailyMed |
Recent Clinical Trials for TRETINOIN MICROSPHERE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Taro Pharmaceuticals USA | Early Phase 1 |
| Galderma Laboratories, L.P. | Phase 4 |
| Spear Pharmaceuticals | Phase 3 |
Pharmacology for TRETINOIN MICROSPHERE
| Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for TRETINOIN MICROSPHERE
US Patents and Regulatory Information for TRETINOIN MICROSPHERE
TRETINOIN MICROSPHERE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting TRETINOIN MICROSPHERE
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Encube | TRETINOIN MICROSPHERE | tretinoin | GEL;TOPICAL | 215609-001 | Aug 22, 2023 | AB | 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 |
