Desloratadine - Generic Drug Details
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What are the generic drug sources for desloratadine and what is the scope of freedom to operate?
Desloratadine
is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Taro, Organon, Reddys, Belcher Pharms, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Orbion Pharms, Perrigo, Sun Pharm Inds, and Organon Llc, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.There are sixteen drug master file entries for desloratadine. Eight suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for desloratadine
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 13 |
NDAs: | 17 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 141 |
Clinical Trials: | 68 |
Patent Applications: | 5,946 |
Drug Prices: | Drug price trends for desloratadine |
What excipients (inactive ingredients) are in desloratadine? | desloratadine excipients list |
DailyMed Link: | desloratadine at DailyMed |
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 |
Generic filers with tentative approvals for DESLORATADINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 5MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 5MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Pharms | DESLORATADINE | desloratadine | TABLET;ORAL | 078352-001 | Oct 25, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Orbion Pharms | DESLORATADINE | desloratadine | TABLET;ORAL | 078357-001 | Feb 19, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Reddys | DESLORATADINE | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 078367-002 | Jul 12, 2010 | RX | No | Yes | ⤷ 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 desloratadine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-002 | Jul 14, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Organon | CLARINEX | desloratadine | TABLET;ORAL | 021165-001 | Dec 21, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Organon | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
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