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TRI-LUMA Drug Profile
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See Plans and PricingWhich patents cover Tri-luma, and what generic alternatives are available?
Tri-luma is a drug marketed by Galderma Labs Lp and is included in one NDA. There are four patents protecting this drug.
This drug has twenty-nine patent family members in eighteen countries.
The generic ingredient in TRI-LUMA is fluocinolone acetonide; hydroquinone; tretinoin. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluocinolone acetonide; hydroquinone; tretinoin profile page.
US ANDA Litigation and Generic Entry Outlook for Tri-luma
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 25, 2022. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TRI-LUMA
| International Patents: | 29 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 37 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRI-LUMA |
| DailyMed Link: | TRI-LUMA at DailyMed |
Generic Entry Opportunity Date for TRI-LUMA
Generic Entry Date for TRI-LUMA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CREAM;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for TRI-LUMA
| Drug Class | Corticosteroid Melanin Synthesis Inhibitor Retinoid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists Melanin Synthesis Inhibitors |
| Physiological Effect | Depigmenting Activity |
US Patents and Regulatory Information for TRI-LUMA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for TRI-LUMA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1223040 | Start Trial |
| Mexico | PA05004404 | Start Trial |
| Russian Federation | 2005115856 | Start Trial |
| Hong Kong | 1088831 | Start Trial |
| Spain | 2565317 | Start Trial |
| European Patent Office | 3002004 | Start Trial |
| Poland | 219020 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TRI-LUMA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2233112 | 132014902285293 | Italy | Start Trial | PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
