By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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TRI-LUMA Drug Profile
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Which patents cover Tri-luma, and when can generic versions of Tri-luma launch?
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.
DrugPatentWatch® 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRI-LUMA |
| What excipients (inactive ingredients) are in TRI-LUMA? | TRI-LUMA excipients list |
| DailyMed Link: | TRI-LUMA at DailyMed |
DrugPatentWatch® Estimated 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 |
ATC Classes for TRI-LUMA
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 | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| >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 |
|---|---|---|
| Spain | 2565317 | Get Started Free |
| Hong Kong | 1223040 | Get Started Free |
| Japan | 5528973 | Get Started Free |
| South Korea | 20050083828 | Get Started Free |
| Denmark | 1562531 | Get Started Free |
| Russian Federation | 2350313 | Get Started Free |
| Poland | 376715 | Get Started Free |
| >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 | Get Started Free | 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 |
