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Last Updated: November 21, 2024

LORATADINE Drug Patent Profile

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Which patents cover Loratadine, and when can generic versions of Loratadine launch?

Loratadine is a drug marketed by Aurobindo Pharma, Bionpharma, Marksans Pharma, Strides Pharma, Taro, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, Perrigo, Pharm Assoc, Ranbaxy Labs Ltd, Teva, Wockhardt Bio Ag, Perrigo Pharma Intl, Sun Pharm, Actavis Labs Fl Inc, Glaxosmithkline, Rubicon, Tenshi, Anda Repository, Apotex Inc, Granules, Hetero Labs Ltd V, Mylan, Norvium Bioscience, Pld Acquisitions Llc, Sun Pharm Inds Ltd, Unique Pharm, Heritage Pharma, and P And L. and is included in forty-four NDAs.

The generic ingredient in LORATADINE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Loratadine

A generic version of LORATADINE was approved as loratadine; pseudoephedrine sulfate by PERRIGO PHARMA INTL on January 30^th, 2003.

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Summary for LORATADINE

US Patents:	0
Applicants:	30
NDAs:	44
Finished Product Suppliers / Packagers:	150
Raw Ingredient (Bulk) Api Vendors:	148
Clinical Trials:	62
Patent Applications:	3,970
Drug Prices:	Drug price information for LORATADINE
Drug Sales Revenues:	Drug sales revenues for LORATADINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LORATADINE
DailyMed Link:	LORATADINE at DailyMed

Drug patent expirations by year for LORATADINE

Drug Prices for LORATADINE

Recent Clinical Trials for LORATADINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AHS Cancer Control Alberta	Phase 2
King Edward Medical University	Phase 4
Ain Shams University	Phase 3

See all LORATADINE clinical trials

Medical Subject Heading (MeSH) Categories for LORATADINE

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists, Non-Sedating

Anatomical Therapeutic Chemical (ATC) Classes for LORATADINE

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for LORATADINE

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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
Perrigo Pharma Intl	LORATADINE AND PSEUDOEPHEDRINE SULFATE	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	076050-001	Jan 30, 2003		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	LORATADINE	loratadine	TABLET;ORAL	078447-001	Aug 12, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Granules	LORATADINE	loratadine	TABLET;ORAL	210722-001	Dec 23, 2019		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Perrigo	LORATADINE	loratadine	TABLET;ORAL	076301-001	Jun 25, 2004		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	LORATADINE	loratadine	TABLET;ORAL	211718-001	Jul 28, 2023		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	LORATADINE	loratadine	CAPSULE;ORAL	211900-001	Mar 24, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl Inc	LORATADINE	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	075990-001	Nov 3, 2003		DISCN	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

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