CARVEDILOL PHOSPHATE - Generic Drug Details
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What are the generic drug sources for carvedilol phosphate and what is the scope of patent protection?
Carvedilol phosphate
is the generic ingredient in two branded drugs marketed by Impax Labs Inc, Sun Pharm Industries, and Waylis Therap, and is included in three NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Carvedilol phosphate has twenty-four patent family members in fourteen countries.
There are nine drug master file entries for carvedilol phosphate. Ten suppliers are listed for this compound.
Summary for CARVEDILOL PHOSPHATE
International Patents: | 24 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 52 |
Clinical Trials: | 5 |
Patent Applications: | 191 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CARVEDILOL PHOSPHATE |
What excipients (inactive ingredients) are in CARVEDILOL PHOSPHATE? | CARVEDILOL PHOSPHATE excipients list |
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 |
University of Minnesota | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for CARVEDILOL PHOSPHATE
Paragraph IV (Patent) Challenges for CARVEDILOL PHOSPHATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
COREG CR | Extended-release Capsules | carvedilol phosphate | 10 mg and 20 mg | 022012 | 1 | 2008-03-18 |
COREG CR | Extended-release Capsules | carvedilol phosphate | 40 mg | 022012 | 1 | 2007-12-21 |
COREG CR | Extended-release Capsules | carvedilol phosphate | 80 mg | 022012 | 1 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Waylis Therap | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-002 | Oct 20, 2006 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Waylis Therap | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-001 | Oct 20, 2006 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Sun Pharm Industries | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 090132-002 | Oct 25, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm Industries | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 090132-004 | Oct 25, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Impax Labs Inc | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 204717-002 | May 7, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 |
---|---|---|---|---|---|---|---|
Waylis Therap | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-003 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Waylis Therap | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-003 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Waylis Therap | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-002 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Waylis Therap | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-001 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Waylis Therap | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-004 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CARVEDILOL PHOSPHATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1976682 | Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active component | ⤷ Sign Up |
China | 1568181 | Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles | ⤷ Sign Up |
China | 100341493 | ⤷ Sign Up | |
Brazil | 0213175 | Forma galênica oral macroparticular para a liberação retardada e controlada de princìpios ativos farmacêuticos | ⤷ Sign Up |
Japan | 2005506336 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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