LORATADINE - Generic Drug Details

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What are the generic sources for loratadine and what is the scope of patent protection?

Loratadine is the generic ingredient in eleven branded drugs marketed by Bayer Healthcare Llc, 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, Fdn Consumer, Actavis Labs Fl Inc, Glaxosmithkline, Rubicon, Tenshi, Sun Pharm Inds Ltd, Anda Repository, Apotex Inc, Granules, Hetero Labs Ltd V, Mylan, Norvium Bioscience, Pld Acquisitions Llc, Unique Pharm, Heritage Pharma, and P And L, and is included in fifty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for loratadine. One hundred and fifty-five suppliers are listed for this compound.

Summary for LORATADINE

US Patents:	0
Tradenames:	11
Applicants:	32
NDAs:	53
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	155
Raw Ingredient (Bulk) Api Vendors:	148
Clinical Trials:	62
Patent Applications:	6,659
Drug Prices:	Drug price trends for LORATADINE
Drug Sales Revenues:	Drug sales revenues for LORATADINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LORATADINE
What excipients (inactive ingredients) are in LORATADINE?	LORATADINE excipients list
DailyMed Link:	LORATADINE at DailyMed

See drug prices for LORATADINE

Drug Sales Revenue Trends for LORATADINE

See drug sales revenues 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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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
Anda Repository	LORATADINE	loratadine	TABLET;ORAL	207569-001	Mar 12, 2019		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	LORATADINE	loratadine	TABLET;ORAL	076134-001	Aug 18, 2003		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Healthcare Llc	CLARITIN HIVES RELIEF REDITAB	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704-003	Nov 19, 2003		OTC	Yes	Yes	⤷ 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
Pharm Assoc	LORATADINE	loratadine	SYRUP;ORAL	075565-001	Oct 5, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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
>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 LORATADINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN REDITABS	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Healthcare Llc	CLARITIN REDITABS	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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