ZIANA Drug Patent Profile

When do Ziana patents expire, and what generic alternatives are available?

Ziana is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in ZIANA is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ziana

A generic version of ZIANA was approved as clindamycin phosphate; tretinoin by ACTAVIS MID ATLANTIC on June 12^th, 2015.

Summary for ZIANA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	14
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZIANA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZIANA
What excipients (inactive ingredients) are in ZIANA?	ZIANA excipients list
DailyMed Link:	ZIANA at DailyMed

See drug prices for ZIANA

Pharmacology for ZIANA

Drug Class	Lincosamide Antibacterial Retinoid
Physiological Effect	Decreased Sebaceous Gland Activity

Anatomical Therapeutic Chemical (ATC) Classes for ZIANA

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

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

G01AA	Antibiotics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01FF	Lincosamides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

L01XF	Retinoids for cancer treatment
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ZIANA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIANA	Gel	clindamycin phosphate; tretinoin	1.2%/0.025%	050802	1	2010-12-17

US Patents and Regulatory Information for ZIANA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	AB1	RX	Yes	Yes

Expired US Patents for ZIANA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006

International Patents for ZIANA

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

Country	Patent Number	Title	Estimated Expiration
Australia	7900201
Japan	2004505900
Portugal	1304992
Germany	60138549
Denmark	2052714

Supplementary Protection Certificates for ZIANA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	474	Finland
1304992	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322