Paricalcitol - Generic Drug Details
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What are the generic drug sources for paricalcitol and what is the scope of patent protection?
Paricalcitol
is the generic ingredient in two branded drugs marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Abbvie, Accord Hlthcare, Amneal Pharms Co, Epic Pharma Llc, Eugia Pharma, Hikma Pharms, Hospira, and Sandoz, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for paricalcitol. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for paricalcitol
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 16 |
NDAs: | 19 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 67 |
Clinical Trials: | 96 |
Patent Applications: | 2,685 |
Drug Prices: | Drug price trends 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 |
Recent Clinical Trials for paricalcitol
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cedars-Sinai Medical Center | Early Phase 1 |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Early Phase 1 |
Chengdu Suncadia Medicine Co., Ltd. | Phase 3 |
Generic filers with tentative approvals for PARICALCITOL
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 10MCG/ML | INJECTABLE; INJECTION |
⤷ Sign Up | ⤷ Sign Up | 5MCG/ML | INJECTABLE; INJECTION |
⤷ Sign Up | ⤷ Sign Up | 2MCG/ML | INJECTABLE; INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for paricalcitol
Drug Class | Vitamin D Analog Vitamin D2 Analog Vitamin D3 Analog |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Epic Pharma Llc | PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 207692-001 | Oct 16, 2017 | DISCN | 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 | |||
Teva Pharms Usa | PARICALCITOL | paricalcitol | CAPSULE;ORAL | 090829-003 | Sep 27, 2013 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma Pharms | PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 205917-001 | Nov 18, 2014 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lotus Pharm Co Ltd | PARICALCITOL | paricalcitol | CAPSULE;ORAL | 206710-001 | Feb 24, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-003 | Feb 1, 2000 | AP | RX | Yes | Yes | ⤷ 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 paricalcitol
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-002 | Feb 1, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-003 | Feb 1, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-001 | Apr 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-002 | May 26, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-003 | May 26, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-003 | Feb 1, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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