ASTELIN Drug Patent Profile
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When do Astelin patents expire, and what generic alternatives are available?
Astelin is a drug marketed by Norvium Bioscience and is included in one NDA.
The generic ingredient in ASTELIN is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Astelin
A generic version of ASTELIN was approved as azelastine hydrochloride by APOTEX INC on April 30th, 2009.
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Summary for ASTELIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 6 |
| Patent Applications: | 1,692 |
| What excipients (inactive ingredients) are in ASTELIN? | ASTELIN excipients list |
| DailyMed Link: | ASTELIN at DailyMed |
Recent Clinical Trials for ASTELIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| MEDA Pharma GmbH & Co. KG | Phase 1 |
| Prolytic GmbH | Phase 1 |
| ClinResearch, GmbH | Phase 1 |
Paragraph IV (Patent) Challenges for ASTELIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ASTELIN | Nasal Spray | azelastine hydrochloride | 0.125 mg base/spray | 020114 | 1 | 2005-11-14 |
US Patents and Regulatory Information for ASTELIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Norvium Bioscience | ASTELIN | azelastine hydrochloride | SPRAY, METERED;NASAL | 020114-001 | Nov 1, 1996 | DISCN | Yes | 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 ASTELIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Norvium Bioscience | ASTELIN | azelastine hydrochloride | SPRAY, METERED;NASAL | 020114-001 | Nov 1, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ASTELIN
See the table below for patents covering ASTELIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 0316633 | MEDICINE CONTAINING AZELASTINE FOR APPLICATION IN THE NOSE AND/OR AT THE EYE | ⤷ Sign Up |
| Germany | 3877904 | ⤷ Sign Up | |
| Denmark | 630188 | ⤷ Sign Up | |
| Australia | 2506388 | ⤷ Sign Up | |
| Japan | 2956029 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ASTELIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1519731 | 92269 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| 1519731 | C300740 | Netherlands | ⤷ Sign Up | PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215 |
| 1519731 | 13C0067 | France | ⤷ Sign Up | PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215 |
| 0316633 | 99C0012 | Belgium | ⤷ Sign Up | PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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