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Last Updated: March 19, 2024

LORATADINE; PSEUDOEPHEDRINE SULFATE - Generic Drug Details


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

Loratadine; pseudoephedrine sulfate is the generic ingredient in three branded drugs marketed by Bayer Healthcare Llc, Heritage Pharma, P And L, Perrigo Pharma Intl, and Sun Pharm Inds Ltd, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-five suppliers are listed for this compound.

Summary for LORATADINE; PSEUDOEPHEDRINE SULFATE
Recent Clinical Trials for LORATADINE; PSEUDOEPHEDRINE SULFATE

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

SponsorPhase
BayerPhase 1
BayerPhase 4
Azidus BrasilPhase 3

See all LORATADINE; PSEUDOEPHEDRINE SULFATE clinical trials

Pharmacology for LORATADINE; PSEUDOEPHEDRINE SULFATE

US Patents and Regulatory Information for LORATADINE; PSEUDOEPHEDRINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Healthcare Llc CLARITIN-D loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019670-002 Nov 27, 2002 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo Pharma Intl LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076050-001 Jan 30, 2003 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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; PSEUDOEPHEDRINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc CLARITIN-D loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019670-002 Nov 27, 2002 ⤷  Try a Trial ⤷  Try a Trial
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002 ⤷  Try a Trial ⤷  Try a Trial
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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