CUTIVATE Drug Patent Profile

Which patents cover Cutivate, and when can generic versions of Cutivate launch?

Cutivate is a drug marketed by Fougera Pharms and is included in three NDAs.

The generic ingredient in CUTIVATE is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cutivate

A generic version of CUTIVATE was approved as fluticasone propionate by FOUGERA PHARMS on May 14^th, 2004.

Summary for CUTIVATE

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	3
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CUTIVATE
What excipients (inactive ingredients) are in CUTIVATE?	CUTIVATE excipients list
DailyMed Link:	CUTIVATE at DailyMed

See drug prices for CUTIVATE

Recent Clinical Trials for CUTIVATE

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

Sponsor	Phase
Fougera Pharmaceuticals Inc.	Phase 4
Children's Hospital of Philadelphia	Phase 4
Novartis Pharmaceuticals	Phase 4

See all CUTIVATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CUTIVATE

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for CUTIVATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CUTIVATE	Lotion	fluticasone propionate	0.05%	021152	1	2008-07-28

US Patents and Regulatory Information for CUTIVATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms	CUTIVATE	fluticasone propionate	CREAM;TOPICAL	019958-001	Dec 18, 1990		DISCN	Yes	No
Fougera Pharms	CUTIVATE	fluticasone propionate	LOTION;TOPICAL	021152-001	Mar 31, 2005		DISCN	Yes	No
Fougera Pharms	CUTIVATE	fluticasone propionate	OINTMENT;TOPICAL	019957-001	Dec 14, 1990		DISCN	Yes	No

Expired US Patents for CUTIVATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	CUTIVATE	fluticasone propionate	CREAM;TOPICAL	019958-001	Dec 18, 1990
Fougera Pharms	CUTIVATE	fluticasone propionate	OINTMENT;TOPICAL	019957-001	Dec 14, 1990
Fougera Pharms	CUTIVATE	fluticasone propionate	LOTION;TOPICAL	021152-001	Mar 31, 2005

International Patents for CUTIVATE

See the table below for patents covering CUTIVATE around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	850000969
Turkey	200101109
Mexico	9202717	CARBOTIOATOS DE ANDROSTANO Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN.

Supplementary Protection Certificates for CUTIVATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117