Trifarotene - Generic Drug Details

✉ Email this page to a colleague

What are the generic drug sources for trifarotene and what is the scope of freedom to operate?

Trifarotene is the generic ingredient in one branded drug marketed by Galderma Labs Lp and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trifarotene has sixty patent family members in twenty-eight countries.

There is one drug master file entry for trifarotene. One supplier is listed for this compound.

Summary for trifarotene

International Patents:	60
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	10
Patent Applications:	89
What excipients (inactive ingredients) are in trifarotene?	trifarotene excipients list
DailyMed Link:	trifarotene at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for trifarotene

Generic Entry Date for trifarotene^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for trifarotene

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Taro Pharmaceuticals USA	Phase 1
Teva Pharmaceuticals USA	Phase 3
Teva Pharmaceuticals, Inc.	Phase 3

See all trifarotene clinical trials

Pharmacology for trifarotene

Drug Class	Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for trifarotene

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for TRIFAROTENE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AKLIEF	Cream	trifarotene	0.005%	211527	2	2023-10-04

US Patents and Regulatory Information for trifarotene

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 trifarotene

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Spain	2691299		⤷ Sign Up
Austria	E542791		⤷ Sign Up
South Korea	20150028251	TOPICAL COMPOSITIONS IN THE FORM OF A GEL CONTAINING A PARTICULAR SOLUBILISED RETINOID	⤷ Sign Up
Slovenia	1831149		⤷ Sign Up
Japan	2015523342	レチノイドを含有する油／水エマルション型局所的組成物	⤷ Sign Up
Russian Federation	2440973	НОВЫЕ ЛИГАНДЫ, МОДУЛИРУЮЩИЕ RAR РЕЦЕПТОРЫ, И ИХ ПРИМЕНЕНИЕ В МЕДИЦИНЕ И В КОСМЕТИЧЕСКИХ ИЗДЕЛИЯХ (RAR RECEPTOR-MODULATING NOVEL LIGANDS, AND USE THEREOF IN MEDICINE AND COSMETIC PRODUCTS)	⤷ Sign Up
New Zealand	702472	Oil/water-emulsion-type topical compositions containing a retinoid	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for trifarotene

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1831149	CA 2020 00027	Denmark	⤷ Sign Up	PRODUCT NAME: TRIFAROTEN, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 61878 20200120; FIRST REG. NO/DATE: UK PL 10590/0071 20200113
1831149	20C1025	France	⤷ Sign Up	PRODUCT NAME: TRIFAROTENE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: CIS 6 363 190 8 20200217; FIRST REGISTRATION: GB - PL 10590/0071 20200113
1831149	2090021-3	Sweden	⤷ Sign Up	PRODUCT NAME: TRIFAROTENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: MT NR:58467 20200131; FIRST REG.: GB PL 10590/0071 20200113
1831149	2020C/525	Belgium	⤷ Sign Up	PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224
1831149	132020000000088	Italy	⤷ Sign Up	PRODUCT NAME: TRIFAROTENE, FACOLTATIVAMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(SELGAMIS); AUTHORISATION NUMBER(S) AND DATE(S): PL 10590/0071 - 0001, 20200113;047209010-022-034-046, 20200520
1831149	301042	Netherlands	⤷ Sign Up	PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATIONAL REGISTRATION NO/DATE: RVG 124058 20200310; FIRST REGISTRATION: GB PL 10590/0071 20200113
1831149	719	Finland	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.