PARICALCITOL Drug Patent Profile
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Which patents cover Paricalcitol, and when can generic versions of Paricalcitol launch?
Paricalcitol is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Accord Hlthcare, Amneal Pharms Co, Epic Pharma Llc, Eugia Pharma, Hikma Pharms, Hospira, and Sandoz. and is included in seventeen NDAs.
The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Paricalcitol
A generic version of PARICALCITOL was approved as paricalcitol by SANDOZ on July 27th, 2011.
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Questions you can ask:
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Summary for PARICALCITOL
| US Patents: | 0 |
| Applicants: | 15 |
| NDAs: | 17 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 96 |
| Patent Applications: | 1,758 |
| Drug Prices: | Drug price information for PARICALCITOL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PARICALCITOL |
| What excipients (inactive ingredients) are in PARICALCITOL? | PARICALCITOL excipients list |
| DailyMed Link: | PARICALCITOL at DailyMed |
See drug prices for PARICALCITOL
Recent Clinical Trials for PARICALCITOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Early Phase 1 |
| Cedars-Sinai Medical Center | Early Phase 1 |
| Chengdu Suncadia Medicine Co., Ltd. | Phase 3 |
Pharmacology for PARICALCITOL
Anatomical Therapeutic Chemical (ATC) Classes for PARICALCITOL
Paragraph IV (Patent) Challenges for PARICALCITOL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ZEMPLAR | Injection | paricalcitol | 0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials | 020819 | 1 | 2008-11-28 |
| ZEMPLAR | Capsules | paricalcitol | 1 mcg and 2 mcg | 021606 | 1 | 2008-10-14 |
| ZEMPLAR | Capsules | paricalcitol | 4 mcg | 021606 | 1 | 2008-08-25 |
US Patents and Regulatory Information for PARICALCITOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 201657-001 | Oct 21, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys | PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 204910-002 | Aug 17, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 091108-003 | Jul 27, 2011 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 203897-002 | Nov 2, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal Pharms Co | PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 206699-001 | Mar 9, 2017 | AP | 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 |
