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 | 076050-001 | Jan 30, 2003 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Inds Ltd | LORATADINE AND PSEUDOEPHEDRINE SULFATE | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 076557-001 | Sep 22, 2004 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Healthcare Llc | CLARITIN-D 24 HOUR | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 020470-002 | Nov 27, 2002 | OTC | Yes | Yes | ⤷ 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 | ||||
| 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 | ||||
| >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 | ⤷ 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 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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