PARICALCITOL - Generic Drug Details

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What are the generic sources for paricalcitol and what is the scope of freedom to operate?

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

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Drug Sales Revenue Trends for PARICALCITOL

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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

See all PARICALCITOL clinical trials

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

H05BX	Other anti-parathyroid agents
H05B	ANTI-PARATHYROID AGENTS
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	PARICALCITOL	paricalcitol	CAPSULE;ORAL	091412-001	Jun 24, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Pharms	PARICALCITOL	paricalcitol	SOLUTION;INTRAVENOUS	205917-003	Nov 18, 2014	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Pharms	PARICALCITOL	paricalcitol	SOLUTION;INTRAVENOUS	205917-002	Nov 18, 2014	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-001	Apr 17, 1998	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-001	Apr 17, 1998	⤷ Sign Up	⤷ Sign Up
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-002	Feb 1, 2000	⤷ Sign Up	⤷ Sign Up
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-002	Feb 1, 2000	⤷ Sign Up	⤷ Sign Up
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606-001	May 26, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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