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Carvedilol - Generic Drug Details
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What are the generic sources for carvedilol and what is the scope of freedom to operate?
Carvedilol
is the generic ingredient in four branded drugs marketed by Aurobindo Pharma, Beximco Usa, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Generics, Hikma, Lupin, Mylan, Pliva Hrvatska Doo, Rubicon, Sandoz, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Taro, Teva, Wockhardt Ltd, Zydus Pharms Usa Inc, Smithkline Beecham, Impax Labs Inc, and Sun Pharm Industries, and is included in twenty-one NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are thirty-seven drug master file entries for carvedilol. Thirty-eight suppliers are listed for this compound.
Summary for carvedilol
US Patents: | 2 |
Tradenames: | 4 |
Applicants: | 20 |
NDAs: | 21 |
Drug Master File Entries: | 37 |
Suppliers / Packagers: | 38 |
Bulk Api Vendors: | 124 |
Clinical Trials: | 160 |
Patent Applications: | 6,632 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for carvedilol |
Drug Sales Revenues: | Drug sales revenues for carvedilol |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for carvedilol |
What excipients (inactive ingredients) are in carvedilol? | carvedilol excipients list |
DailyMed Link: | carvedilol at DailyMed |
Recent Clinical Trials for carvedilol
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Weill Medical College of Cornell University | Phase 4 |
National Institute on Aging (NIA) | Phase 4 |
University of Alabama at Birmingham | Phase 4 |
Pharmacology for carvedilol
Drug Class | alpha-Adrenergic Blocker beta-Adrenergic Blocker |
Mechanism of Action | Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists |
Paragraph IV (Patent) Challenges for CARVEDILOL
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
COREG | TABLET;ORAL | carvedilol | 020297 |
US Patents and Regulatory Information for carvedilol
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Beximco Usa | CARVEDILOL | carvedilol | TABLET;ORAL | 078384-002 | Sep 5, 2007 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Taro | CARVEDILOL | carvedilol | TABLET;ORAL | 077780-002 | Sep 5, 2007 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Rubicon | CARVEDILOL | carvedilol | TABLET;ORAL | 078165-001 | Sep 5, 2007 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Hikma | CARVEDILOL | carvedilol | TABLET;ORAL | 077887-003 | Sep 7, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-003 | Sep 14, 1995 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Smithkline Beecham | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-002 | Oct 20, 2006 | AB | RX | Yes | No | Start Trial | Start Trial | Y | 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 carvedilol
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-001 | Sep 14, 1995 | Start Trial | Start Trial |
Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-003 | Sep 14, 1995 | Start Trial | Start Trial |
Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-004 | May 29, 1997 | Start Trial | Start Trial |
Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-004 | May 29, 1997 | Start Trial | Start Trial |
Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-001 | Sep 14, 1995 | Start Trial | Start Trial |
Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-001 | Sep 14, 1995 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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