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Carvedilol phosphate - Generic Drug Details
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What are the generic drug sources for carvedilol phosphate and what is the scope of freedom to operate?
Carvedilol phosphate
is the generic ingredient in two branded drugs marketed by Impax Labs Inc, Sun Pharm Industries, and Smithkline Beecham, and is included in three NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Carvedilol phosphate has fifty-one patent family members in seventeen countries.
There are thirty-seven drug master file entries for carvedilol phosphate. Four suppliers are listed for this compound.
Summary for carvedilol phosphate
| International Patents: | 51 |
| US Patents: | 2 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 37 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 146 |
| Clinical Trials: | 5 |
| Patent Applications: | 6,290 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for carvedilol phosphate |
| DailyMed Link: | carvedilol phosphate at DailyMed |
Recent Clinical Trials for carvedilol phosphate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 1 |
| University of Minnesota - Clinical and Translational Science Institute | Phase 1/Phase 2 |
| GlaxoSmithKline | Phase 1/Phase 2 |
Pharmacology for carvedilol phosphate
| 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 PHOSPHATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| COREG CR | CAPSULE, EXTENDED RELEASE;ORAL | carvedilol phosphate | 022012 | 2008-03-18 |
| COREG CR | CAPSULE, EXTENDED RELEASE;ORAL | carvedilol phosphate | 022012 | 2007-12-21 |
| COREG CR | CAPSULE, EXTENDED RELEASE;ORAL | carvedilol phosphate | 022012 | 2007-11-19 |
US Patents and Regulatory Information for carvedilol phosphate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Industries | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 090132-003 | Oct 25, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Impax Labs Inc | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 204717-003 | May 7, 2018 | AB | RX | No | 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 phosphate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Smithkline Beecham | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-004 | Oct 20, 2006 | Start Trial | Start Trial |
| Smithkline Beecham | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-001 | Oct 20, 2006 | Start Trial | Start Trial |
| Smithkline Beecham | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-003 | Oct 20, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for carvedilol phosphate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | PI0213175 | Start Trial |
| Japan | 5422545 | Start Trial |
| South Korea | 20130042047 | Start Trial |
| >Country | >Patent Number | >Estimated 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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