CARVEDILOL PHOSPHATE Drug Patent Profile
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When do Carvedilol Phosphate patents expire, and when can generic versions of Carvedilol Phosphate launch?
Carvedilol Phosphate is a drug marketed by Impax Labs Inc and Sun Pharm Industries and is included in two NDAs.
The generic ingredient in CARVEDILOL PHOSPHATE is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Carvedilol Phosphate
A generic version of CARVEDILOL PHOSPHATE was approved as carvedilol phosphate by SUN PHARM INDUSTRIES on October 25th, 2017.
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Questions you can ask:
- What is the 5 year forecast for CARVEDILOL PHOSPHATE?
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- What is Average Wholesale Price for CARVEDILOL PHOSPHATE?
Summary for CARVEDILOL PHOSPHATE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 52 |
| Clinical Trials: | 5 |
| Patent Applications: | 127 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax Labs Inc | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 204717-001 | May 7, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm Industries | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 090132-003 | Oct 25, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Impax Labs Inc | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 204717-004 | May 7, 2018 | 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
