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Last Updated: March 5, 2021

DrugPatentWatch Database Preview

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
Drug Prices for captopril

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Recent Clinical Trials for captopril

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

SponsorPhase
Case Comprehensive Cancer CenterPhase 1/Phase 2
Kafrelsheikh UniversityPhase 2
Assistance Publique - Hôpitaux de ParisPhase 2

See all captopril clinical trials

Pharmacology for captopril
Medical Subject Heading (MeSH) Categories for captopril
Paragraph IV (Patent) Challenges for CAPTOPRIL
Tradename Dosage Ingredient NDA Submissiondate
CAPOTEN TABLET;ORAL captopril 018343

US Patents and Regulatory Information for captopril

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

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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Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Colorcon
McKesson
Harvard Business School
Johnson and Johnson

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