Loratadine - Generic Drug Details
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What are the generic drug 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 |
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 |
Medical Subject Heading (MeSH) Categories for loratadine
Anatomical Therapeutic Chemical (ATC) Classes for loratadine
US Patents and Regulatory Information for loratadine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hetero Labs Ltd Iii | LORATADINE | loratadine | SYRUP;ORAL | 210409-001 | May 7, 2021 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | LORATADINE | loratadine | TABLET;ORAL | 075790-001 | Nov 7, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | LORATADINE | loratadine | TABLET;ORAL | 076154-001 | Aug 20, 2003 | OTC | No | No | ⤷ 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 | ||||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
