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Ramipril - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ramipril?

Ramipril is the generic ingredient in two branded drugs marketed by West-ward Pharms Int, King Pharms, Aurobindo Pharma Ltd, Cipla, Actavis Elizabeth, Sandoz, Apotex, King Pfizer, Lupin, Zydus Pharms Usa, Invagen Pharms, Ranbaxy Labs Ltd, Watson Labs, Mylan Pharms Inc, Apotex Inc, Teva Pharms, Dr Reddys Labs Ltd, Accord Hlthcare Inc, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ramipril has forty-three patent family members in thirty-one countries.

There are nineteen drug master file entries for ramipril. Thirty-five suppliers are listed for this compound.

Summary for Generic Name: ramipril

Tradenames:2
Patents:2
Applicants:19
NDAs:19
Drug Master File Entries: see list19
Suppliers / Packagers: see list35
Bulk Api Vendors: see list58
Clinical Trials: see list33
Patent Applications: see list6,488
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ramipril at DailyMed

Pharmacology for Ingredient: ramipril

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
King Pfizer
ALTACE
ramipril
TABLET;ORAL022021-002Feb 27, 2007DISCNYesNo7,368,469► Subscribe ► Subscribe
Apotex
RAMIPRIL
ramipril
CAPSULE;ORAL079116-002Jun 20, 2008RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
RAMIPRIL
ramipril
TABLET;ORAL090650-002Jun 30, 2011DISCNNoNo► Subscribe► Subscribe
Apotex
RAMIPRIL
ramipril
CAPSULE;ORAL079116-004Jun 20, 2008RXNoNo► Subscribe► Subscribe
Actavis Elizabeth
RAMIPRIL
ramipril
CAPSULE;ORAL077513-004Jun 18, 2008DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ramipril

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pfizer
ALTACE
ramipril
TABLET;ORAL022021-002Feb 27, 20075,403,856► Subscribe
King Pharms
ALTACE
ramipril
CAPSULE;ORAL019901-004Jan 28, 19915,403,856► Subscribe
King Pharms
ALTACE
ramipril
CAPSULE;ORAL019901-001Jan 28, 19914,587,258► Subscribe
King Pharms
ALTACE
ramipril
CAPSULE;ORAL019901-004Jan 28, 19914,587,258► Subscribe
King Pfizer
ALTACE
ramipril
TABLET;ORAL022021-001Feb 27, 20075,061,722► Subscribe
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International Patent Family for Ingredient: ramipril

Country Document Number Estimated Expiration
Hungary0203326► Subscribe
World Intellectual Property Organization (WIPO)0115674► Subscribe
Hong Kong1048267► Subscribe
Denmark1216038► Subscribe
European Patent Office1216038► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RAMIPRIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
80030Netherlands► SubscribePRODUCT 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
C0001Belgium► SubscribePRODUCT NAME: FELODIPINUM + RAMIPRILUM; NATL. REGISTRATION NO/DATE: 354 IS 373 F 3 19981103; FIRST REGISTRATION: SE 13597 19970919
C/GB98/047United Kingdom► SubscribePRODUCT 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
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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