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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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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 verification 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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