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 Woodward, 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 nine drug master file entries for carvedilol phosphate. Seven 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: | 9 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 43 |
Clinical Trials: | 5 |
Patent Applications: | 237 |
Formulation / Manufacturing: | see details |
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 |
GlaxoSmithKline | Phase 1/Phase 2 |
University of Minnesota - Clinical and Translational Science Institute | 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 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Woodward | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-002 | Oct 20, 2006 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Sun Pharm Industries | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 090132-002 | Oct 25, 2017 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Impax Labs Inc | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 204717-002 | May 7, 2018 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 |
---|---|---|---|---|---|---|---|
Woodward | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-004 | Oct 20, 2006 | See Plans and Pricing | See Plans and Pricing |
Woodward | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-003 | Oct 20, 2006 | See Plans and Pricing | See Plans and Pricing |
Woodward | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-002 | Oct 20, 2006 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for carvedilol phosphate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | PA04012923 | SALES DE FOSFATO DE CARVEDILOL Y/O SOLVATOS DE LAS MISMAS, COMPOSICIONES CORRESPONDIENTES Y/O METODOS DE TRATAMIENTO. (CARVEDILOL PHOSPHATE SALTS AND/OR SOLVATES THEREOF, CORRESPONDINQ COMPOSITIONS, AND/OR METHODS OF TREATMENT.) | See Plans and Pricing |
South Korea | 20100063825 | GALENIC MICROPARTICULATE ORAL FORMULATION FOR DELAYED AND CONTROLLED RELEASE OF PHARMACEUTICAL ACTIVE PRINCIPLES | See Plans and Pricing |
South Africa | 200410011 | Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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