Ramipril - Generic Drug Details

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What are the generic drug sources for ramipril and what is the scope of patent protection?

Ramipril is the generic ingredient in two branded drugs marketed by King Pharms Llc, Accord Hlthcare, Actavis Elizabeth, Apotex, Aurobindo Pharma Ltd, Chartwell Molecular, Cipla, Dr Reddys Labs Ltd, Hikma, Lupin, Ranbaxy Labs Ltd, Teva Pharms, Watson Labs, Yaopharma Co Ltd, Zydus Pharms Usa, King Pfizer, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are nineteen drug master file entries for ramipril. Twenty-two suppliers are listed for this compound.

Summary for ramipril

International Patents:	47
US Patents:	1
Tradenames:	2
Applicants:	18
NDAs:	19
Drug Master File Entries:	19
Suppliers / Packagers:	22
Bulk Api Vendors:	83
Clinical Trials:	145
Patent Applications:	6,940
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ramipril
Drug Sales Revenues:	Drug sales revenues for ramipril
What excipients (inactive ingredients) are in ramipril?	ramipril excipients list
DailyMed Link:	ramipril at DailyMed

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See drug sales revenues for ramipril

Recent Clinical Trials for ramipril

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Sponsor	Phase
University of Bari	Phase 4
Fondazione Schena	Phase 4
University of California, San Diego	Phase 2

See all ramipril clinical trials

Pharmacology for ramipril

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

Medical Subject Heading (MeSH) Categories for ramipril

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents

Paragraph IV (Patent) Challenges for RAMIPRIL

Tradename	Dosage	Ingredient	NDA	Submissiondate
ALTACE	CAPSULE;ORAL	ramipril	019901

US Patents and Regulatory Information for ramipril

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	RAMIPRIL	ramipril	CAPSULE;ORAL	091604-002	Jun 8, 2011	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Cipla	RAMIPRIL	ramipril	CAPSULE;ORAL	077004-004	Aug 7, 2008		DISCN	No	No	Start Trial	Start Trial				Start Trial
Dr Reddys Labs Ltd	RAMIPRIL	ramipril	CAPSULE;ORAL	078191-004	Jun 18, 2008	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Aurobindo Pharma Ltd	RAMIPRIL	ramipril	CAPSULE;ORAL	091604-001	Jun 8, 2011	AB	RX	No	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 ramipril

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-003	Feb 27, 2007	Start Trial	Start Trial
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-001	Feb 27, 2007	Start Trial	Start Trial
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-004	Jan 28, 1991	Start Trial	Start Trial
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-002	Jan 28, 1991	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ramipril

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Country	Patent Number	Estimated Expiration
Germany	60022525	Start Trial
Hong Kong	1048267	Start Trial
Israel	148127	Start Trial
Czech Republic	300687	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ramipril

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0265685	99C0001	Belgium	Start Trial	PRODUCT NAME: FELODIPINUM + RAMIPRILUM; NATL. REGISTRATION NO/DATE: 354 IS 373 F 3 19981103; FIRST REGISTRATION: SE 13597 19970919
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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