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Last Updated: December 3, 2020

DrugPatentWatch Database Preview

ALTACE Drug Profile

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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 24th, 2005.

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Drug patent expirations by year for ALTACE
Drug Prices for ALTACE

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Drug Sales Revenue Trends for ALTACE

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Recent Clinical Trials for ALTACE

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

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

See all ALTACE clinical trials

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

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

Supplementary Protection Certificates for ALTACE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0050800 96C0028 Belgium   Start Trial PRODUCT NAME: PORFIMERE SODIQUE; NAT. REGISTRATION NO/DATE: NL 19150 19960409; FIRST REGISTRATION: NL - RVG 16652 19940411
0265685 SPC/GB98/047 United Kingdom   Start Trial 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   Start Trial 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   Start Trial SPC/GB93/145, EXPIRES: 20040109
0265685 99C0001 Belgium   Start Trial PRODUCT NAME: FELODIPINUM + RAMIPRILUM; NATL. REGISTRATION NO/DATE: 354 IS 373 F 3 19981103; FIRST REGISTRATION: SE 13597 19970919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Johnson and Johnson
Mallinckrodt
Baxter
McKinsey

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