AVITA Drug Patent Profile

When do Avita patents expire, and when can generic versions of Avita launch?

Avita is a drug marketed by Mylan Pharms Inc and Mylan and is included in two NDAs.

The generic ingredient in AVITA is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Avita

A generic version of AVITA was approved as tretinoin by PADAGIS US on December 24^th, 1998.

Summary for AVITA

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	142
Patent Applications:	1,465
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AVITA
Drug Sales Revenues:	Drug sales revenues for AVITA
What excipients (inactive ingredients) are in AVITA?	AVITA excipients list
DailyMed Link:	AVITA at DailyMed

See drug prices for AVITA

See drug sales revenues for AVITA

Anatomical Therapeutic Chemical (ATC) Classes for AVITA

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

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

US Patents and Regulatory Information for AVITA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Pharms Inc	AVITA	tretinoin	CREAM;TOPICAL	020404-003	Jan 14, 1997	AB	RX	No	No
Mylan	AVITA	tretinoin	GEL;TOPICAL	020400-001	Jan 29, 1998		DISCN	No	No

Expired US Patents for AVITA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Pharms Inc	AVITA	tretinoin	CREAM;TOPICAL	020404-003	Jan 14, 1997
Mylan Pharms Inc	AVITA	tretinoin	CREAM;TOPICAL	020404-003	Jan 14, 1997

International Patents for AVITA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0299758	Compositions augmentant la pénétration cutanée d'agents pharmaceutiquement actifs. (Compositions for enhancing the cutaneous penetration of pharmacologically active agents.)
Ireland	66710	Compositions for enhancing the cutaneous penetration of pharmacologically active agents
New Zealand	225416	CUTANEOUS PENETRATION-ENHANCING COMPOUNDS, PREPARATION AND COMPOSITIONS THEREOF, AND METHOD OF USE TOGETHER WITH AN ACTIVE AGENT
Israel	87133	POLYOXYALKYLENE-POLYURETHANE CONTAINING COMPOSITION FOR ENHANCING THE CUTANEOUS PENETRATION OF PHARMACOLOGICALLY ACTIVE COMPOUNDS
Canada	1331861	METHODE ET COMPOSITIONS POUR AUGMENTER LA PENETRATION CUTANEE D'AGENTS PHARMACEUTIQUES ACTIFS (METHOD AND COMPOSITIONS FOR ENHANCING THE CUTANEOUS PENETRATION OF PHARMACOLOGICALLY ACTIVE AGENTS)

Supplementary Protection Certificates for AVITA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992	PA2013025	Lithuania		PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
0617614	2001/009	Ireland		PRODUCT NAME: PANRETIN-ALITRETINOIN
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE