ALTRENO Drug Patent Profile

Which patents cover Altreno, and what generic alternatives are available?

Altreno is a drug marketed by Dow Pharm and is included in one NDA. There are two patents protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in ALTRENO 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 Altreno

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

Summary for ALTRENO

International Patents:	6
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	2
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ALTRENO
What excipients (inactive ingredients) are in ALTRENO?	ALTRENO excipients list
DailyMed Link:	ALTRENO at DailyMed

See drug prices for ALTRENO

Recent Clinical Trials for ALTRENO

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

Sponsor	Phase
Beth Israel Deaconess Medical Center	Phase 4
Ortho Dermatologics	Phase 4
Goldman, Butterwick, Fitzpatrick and Groff	Phase 4

See all ALTRENO clinical trials

Pharmacology for ALTRENO

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for ALTRENO

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 ALTRENO

ALTRENO is protected by two US patents.

Patents protecting ALTRENO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018		RX	Yes	Yes			Y
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018		RX	Yes	Yes

Expired US Patents for ALTRENO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018

International Patents for ALTRENO

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20030057526
Japan	2004505900
Slovenia	1304992
Canada	3095937	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINEES A TRAITER DES AFFECTIONS CUTANEES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)
Denmark	1304992

Supplementary Protection Certificates for ALTRENO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1304992	474	Finland
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
0617614	C300043	Netherlands		PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506