Captopril - Generic Drug Details

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What are the generic drug sources for captopril and what is the scope of freedom to operate?

Captopril is the generic ingredient in seven branded drugs marketed by Par Pharm, Ajanta Pharma Ltd, Annora Pharma, Apothecon, Boscogen, Cosette, Dava Pharms Inc, Egis Pharms, G And W Labs Inc, Hikma Intl Pharms, Mylan, Oxford Pharms, Prinston Inc, Purepac Pharm, Sandoz, Seton Pharms, Teva, Watson Labs, Wockhardt Ltd, Yaopharma Co Ltd, Ivax Sub Teva Pharms, and Vintage Pharms Llc, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for captopril. Thirteen suppliers are listed for this compound.

Summary for captopril

US Patents:	0
Tradenames:	7
Applicants:	22
NDAs:	32
Drug Master File Entries:	15
Suppliers / Packagers:	13
Bulk Api Vendors:	106
Clinical Trials:	41
Patent Applications:	6,978
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for captopril
What excipients (inactive ingredients) are in captopril?	captopril excipients list
DailyMed Link:	captopril at DailyMed

See drug prices for captopril

Recent Clinical Trials for captopril

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

Sponsor	Phase
Case Comprehensive Cancer Center	Phase 1/Phase 2
Kafrelsheikh University	Phase 2
Assistance Publique - Hôpitaux de Paris	Phase 2

See all captopril clinical trials

Pharmacology for captopril

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

Medical Subject Heading (MeSH) Categories for captopril

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents

Paragraph IV (Patent) Challenges for CAPTOPRIL

Tradename	Dosage	Ingredient	NDA	Submissiondate
CAPOTEN	TABLET;ORAL	captopril	018343

US Patents and Regulatory Information for captopril

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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
Vintage Pharms Llc	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	captopril; hydrochlorothiazide	TABLET;ORAL	074788-003	Dec 29, 1997		DISCN	No	No	Start Trial	Start Trial				Start Trial
Teva	CAPTOPRIL	captopril	TABLET;ORAL	074322-003	Feb 13, 1996		DISCN	No	No	Start Trial	Start Trial				Start Trial
Vintage Pharms Llc	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	captopril; hydrochlorothiazide	TABLET;ORAL	074788-001	Dec 29, 1997		DISCN	No	No	Start Trial	Start Trial				Start Trial
Seton Pharms	CAPTOPRIL	captopril	TABLET;ORAL	212223-001	Oct 30, 2019		DISCN	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 captopril

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-004	Jun 13, 1995	Start Trial	Start Trial
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-007	Jun 13, 1995	Start Trial	Start Trial
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-005	Jan 17, 1985	Start Trial	Start Trial
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-002	Approved Prior to Jan 1, 1982	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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