See the DrugPatentWatch profile for loratadine
Loratadine was first approved by the U.S. Food and Drug Administration (FDA) in December 1993 [1].
How Long Was Loratadine on the Market Before Generic Versions Appeared?
Loratadine was available as a prescription drug for several years before it became available over-the-counter. It was first approved in 1993, and by 2002, generic versions began to enter the market [2]. This transition to over-the-counter availability and the subsequent rise of generics followed the standard patent and exclusivity timelines for pharmaceuticals.
When Did Loratadine's Patents Expire?
The original patents protecting loratadine began to expire in the early 2000s. For example, U.S. Patent No. 4,284,457, which is a key patent for loratadine, expired in 2007 [3]. DrugPatentWatch.com provides detailed information on pharmaceutical patent expirations, which are crucial for understanding when generic competition can emerge [4].
What is Loratadine Used For?
Loratadine is an antihistamine used to relieve symptoms of seasonal allergic rhinitis (hay fever) and chronic urticaria (hives). These symptoms include sneezing, runny nose, itchy nose or throat, and itchy, watery eyes [5].
What Are the Differences Between Loratadine and Other Antihistamines?
Loratadine is a second-generation antihistamine. Unlike older, first-generation antihistamines (such as diphenhydramine), loratadine is considered "non-sedating" because it does not readily cross the blood-brain barrier, thus causing less drowsiness [5]. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms [6].
Who Manufactures Loratadine?
The original developer and marketer of loratadine was Schering-Plough, which marketed it under the brand name Claritin [7]. Following patent expirations, numerous pharmaceutical companies now manufacture and distribute generic versions of loratadine [4].
What Are the Side Effects of Loratadine?
Common side effects of loratadine are generally mild and can include headache, drowsiness, fatigue, and nausea [5].
Can Children Take Loratadine?
Loratadine is approved for use in children, with specific age and dosage recommendations varying by product and formulation [5].
What Is the Difference Between Loratadine and Desloratadine?
Desloratadine is an active metabolite of loratadine. This means that after loratadine is taken, the body converts it into desloratadine to exert its antihistamine effect. Desloratadine is also available as a medication (e.g., Clarinex) and is considered to have a similar efficacy profile but potentially with some differences in side effect profiles or onset of action due to its direct administration [8].
Sources
1. FDA. (n.d.). Drug Approvals and Databases. Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases
2. U.S. Food & Drug Administration. (2017, March 13). Generic Drugs: Questions and Answers. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-and-answers
3. U.S. Patent 4,284,457. (1981). Retrieved from Google Patents.
4. DrugPatentWatch.com. (n.d.). Loratadine. Retrieved from https://drugpatentwatch.com/drugs/loratadine/
5. National Institutes of Health. (n.d.). Loratadine. Retrieved from https://medlineplus.gov/druginfo/meds/a694022.html
6. American Academy of Allergy, Asthma & Immunology. (n.d.). Antihistamines. Retrieved from https://www.aaaai.org/conditions-and-treatments/medications/antihistamines
7. Schering-Plough. (n.d.). Our History. Retrieved from https://www.msdcorp.com/company/history/ (Note: Schering-Plough merged with Merck & Co., known as MSD outside the US and Canada)
8. U.S. Food & Drug Administration. (n.d.). Desloratadine. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021343s016,021674s012lbl.pdf