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-one suppliers are listed for this compound.
Summary for loratadine; pseudoephedrine sulfate
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 6 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 31 |
| 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 | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Bayer Healthcare Llc | CLARITIN-D 24 HOUR | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 020470-002 | Nov 27, 2002 | OTC | Yes | Yes | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Bionpharma | LORATADINE AND PSEUDOEPHEDRINE SULFATE | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 218017-001 | May 14, 2024 | OTC | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Bayer Healthcare Llc | CLARITIN-D | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 019670-002 | Nov 27, 2002 | OTC | Yes | Yes | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Heritage Pharma | LORATADINE AND PSEUDOEPHEDRINE SULFATE | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 076208-001 | Jan 28, 2004 | DISCN | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| >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 | 4,659,716*PED | ⤷ Get Started Free |
| Bayer Healthcare Llc | CLARITIN-D 24 HOUR | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 020470-002 | Nov 27, 2002 | 4,863,931*PED | ⤷ Get Started Free |
| Bayer Healthcare Llc | CLARITIN-D 24 HOUR | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 020470-002 | Nov 27, 2002 | 5,314,697*PED | ⤷ Get Started Free |
| Bayer Healthcare Llc | CLARITIN-D 24 HOUR | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 020470-002 | Nov 27, 2002 | 4,659,716*PED | ⤷ Get Started Free |
| Bayer Healthcare Llc | CLARITIN-D | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 019670-002 | Nov 27, 2002 | 4,863,931*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Market Dynamics and Financial Trajectory for Loratadine and Pseudoephedrine Sulfate
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