Loratadine; pseudoephedrine sulfate - Generic Drug Details
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What are the generic drug 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, Bionpharma, Heritage Pharma, P And L, Perrigo Pharma Intl, and Sun Pharm Inds Ltd, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.Thirty-two suppliers are listed for this compound.
Summary for loratadine; pseudoephedrine sulfate
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 6 |
NDAs: | 8 |
Finished Product Suppliers / Packagers: | 32 |
Clinical Trials: | 6 |
DailyMed Link: | loratadine; pseudoephedrine sulfate at DailyMed |
Recent Clinical Trials for loratadine; pseudoephedrine sulfate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bayer | Phase 1 |
Bayer | Phase 4 |
Azidus Brasil | Phase 3 |
Pharmacology for loratadine; pseudoephedrine sulfate
Drug Class | alpha-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Perrigo Pharma Intl | LORATADINE AND PSEUDOEPHEDRINE SULFATE | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 075989-001 | Mar 4, 2004 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bayer Healthcare Llc | CLARITIN-D | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 019670-002 | Nov 27, 2002 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
P And L | LORATADINE AND PSEUDOEPHEDRINE SULFATE | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 075706-001 | Feb 21, 2003 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Heritage Pharma | LORATADINE AND PSEUDOEPHEDRINE SULFATE | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 076208-001 | Jan 28, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bionpharma | LORATADINE AND PSEUDOEPHEDRINE SULFATE | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 218017-001 | May 14, 2024 | 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; pseudoephedrine sulfate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Healthcare Llc | CLARITIN-D 24 HOUR | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 020470-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Healthcare Llc | CLARITIN-D | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 019670-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Healthcare Llc | CLARITIN-D 24 HOUR | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 020470-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Healthcare Llc | CLARITIN-D 24 HOUR | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 020470-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Healthcare Llc | CLARITIN-D | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 019670-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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