DESLORATADINE Drug Patent Profile
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When do Desloratadine patents expire, and when can generic versions of Desloratadine launch?
Desloratadine is a drug marketed by Taro, Reddys, Belcher Pharms, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Orbion Pharms, Perrigo, and Sun Pharm Inds. and is included in twelve NDAs.
The generic ingredient in DESLORATADINE is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.
Summary for DESLORATADINE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 141 |
| Clinical Trials: | 68 |
| Patent Applications: | 4,322 |
| Drug Prices: | Drug price information for DESLORATADINE |
| DailyMed Link: | DESLORATADINE at DailyMed |
See drug prices for DESLORATADINE
Recent Clinical Trials for DESLORATADINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eurofarma Laboratorios S.A. | Phase 3 |
| University of Victoria | N/A |
| J. Uriach and Company | Phase 1 |
Pharmacology for DESLORATADINE
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for DESLORATADINE
Paragraph IV (Patent) Challenges for DESLORATADINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CLARINEX | Oral Solution | desloratadine | 0.5 mg/mL | 021300 | 1 | 2008-05-08 |
| CLARINEX | Orally Disintegrating Tablets | desloratadine | 2.5 mg and 5 mg | 021165 | 3 | 2006-06-21 |
US Patents and Regulatory Information for DESLORATADINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taro | DESLORATADINE | desloratadine | SOLUTION;ORAL | 202592-001 | Jun 30, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dash Pharms | DESLORATADINE | desloratadine | TABLET;ORAL | 078351-001 | Feb 10, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Reddys | DESLORATADINE | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 078367-002 | Jul 12, 2010 | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for DESLORATADINE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Actavis Group PTC ehf | Desloratadine Actavis | desloratadine | EMEA/H/C/002435 Treatment of allergic rhinitis and urticaria. |
Authorised | yes | no | no | 2012-01-13 | |
| N.V. Organon | Azomyr | desloratadine | EMEA/H/C/000310 Azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5.1)urticaria (see section 5.1) |
Authorised | no | no | no | 2001-01-15 | |
| Ratiopharm GmbH | Desloratadine ratiopharm | desloratadine | EMEA/H/C/002404 Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician |
Authorised | yes | no | no | 2012-01-13 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
