DrugPatentWatch Database Preview

ALTACE Drug Profile

« Back to Dashboard

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

Altace is a drug marketed by King Pharms Llc and King Pfizer and is included in two NDAs. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

The generic ingredient in ALTACE is ramipril. There are nineteen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ramipril profile page.

US ANDA Litigation and Generic Entry Outlook for Altace

A generic version of ALTACE was approved as ramipril by WATSON LABS on October 24^th, 2005.

Summary for ALTACE

International Patents:	47
US Patents:	1
Applicants:	2
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	80
Clinical Trials:	15
Patent Applications:	2,622
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ALTACE
DailyMed Link:	ALTACE at DailyMed

See drug prices for ALTACE

See drug sales revenues for ALTACE

Recent Clinical Trials for ALTACE

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Wake Forest University Health Sciences	Phase 2
Ferrer Internacional S.A.	Phase 2

See all ALTACE clinical trials

Pharmacology for ALTACE

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Paragraph IV (Patent) Challenges for ALTACE

Tradename	Dosage	Ingredient	NDA	Submissiondate
ALTACE	CAPSULE;ORAL	ramipril	019901

US Patents and Regulatory Information for ALTACE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-001	Jan 28, 1991	AB	RX	Yes	No
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-003	Feb 27, 2007		DISCN	Yes	No
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-004	Jan 28, 1991	AB	RX	Yes	Yes
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-004	Feb 27, 2007		DISCN	Yes	No
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-002	Jan 28, 1991	AB	RX	Yes	No
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-003	Jan 28, 1991	AB	RX	Yes	No

Expired US Patents for ALTACE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-002	Feb 27, 2007
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-004	Feb 27, 2007
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-003	Jan 28, 1991
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-003	Feb 27, 2007
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-004	Jan 28, 1991
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-003	Feb 27, 2007

International Patents for ALTACE

Country	Patent Number	Estimated Expiration
Greece	77381
Mexico	PA02001694
Slovakia	2692002
Japan	H0745410
South Africa	200201470
South Korea	840002354

Supplementary Protection Certificates for ALTACE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0050800	96C0028	Belgium		PRODUCT NAME: PORFIMERE SODIQUE; NAT. REGISTRATION NO/DATE: NL 19150 19960409; FIRST REGISTRATION: NL - RVG 16652 19940411
0265685	SPC/GB98/047	United Kingdom		PRODUCT NAME: COMBINATIONS OF RAMIPRIL, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND FELODIPINE, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: SE 13596 19970919; SE 13597 19970919; UK 00017/0402 19980825; UK 00017/0403 19980825
0265685	C980030	Netherlands		PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919
0079022	SPC/GB93/145	United Kingdom		SPC/GB93/145, EXPIRES: 20040109
0265685	99C0001	Belgium		PRODUCT NAME: FELODIPINUM + RAMIPRILUM; NATL. REGISTRATION NO/DATE: 354 IS 373 F 3 19981103; FIRST REGISTRATION: SE 13597 19970919