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Azelastine hydrochloride - Generic Drug Details
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What are the generic drug sources for azelastine hydrochloride and what is the scope of freedom to operate?
Azelastine hydrochloride
is the generic ingredient in six branded drugs marketed by Akorn, Alembic Pharms Ltd, Apotex Inc, Gland Pharma Ltd, Sandoz Inc, Somerset Theraps Llc, Sun Pharm, Mylan Speciality Lp, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Breckenridge, Hikma, Perrigo Israel, Upsher Smith Labs, Zydus Pharms, and Apotex, and is included in twenty-eight NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Azelastine hydrochloride has fifty patent family members in twenty-four countries.
There are twelve drug master file entries for azelastine hydrochloride. Nineteen suppliers are listed for this compound.
Summary for azelastine hydrochloride
| International Patents: | 50 |
| US Patents: | 7 |
| Tradenames: | 6 |
| Applicants: | 17 |
| NDAs: | 28 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 19 |
| Bulk Api Vendors: | 89 |
| Clinical Trials: | 37 |
| Patent Applications: | 1,248 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for azelastine hydrochloride |
| DailyMed Link: | azelastine hydrochloride at DailyMed |
Recent Clinical Trials for azelastine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kahramanmaras Sutcu Imam University | Phase 3 |
| Diskapi Yildirim Beyazit Education and Research Hospital | Phase 3 |
| Istanbul Training and Research Hospital | Phase 3 |
Pharmacology for azelastine hydrochloride
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ASTEPRO | SPRAY, METERED;NASAL | azelastine hydrochloride | 022203 | 2011-12-15 |
| OPTIVAR | SOLUTION/DROPS;OPHTHALMIC | azelastine hydrochloride | 021127 | 2006-12-13 |
| ASTELIN | SPRAY, METERED;NASAL | azelastine hydrochloride | 020114 | 2005-11-14 |
US Patents and Regulatory Information for azelastine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gland Pharma Ltd | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 210092-001 | Feb 25, 2020 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hikma | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 207243-001 | Sep 22, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Amneal | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 208199-001 | Dec 15, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >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 azelastine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127-001 | May 22, 2000 | Start Trial | Start Trial |
| Mylan Speciality Lp | OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127-001 | May 22, 2000 | Start Trial | Start Trial |
| Mylan Speciality Lp | ASTELIN | azelastine hydrochloride | SPRAY, METERED;NASAL | 020114-001 | Nov 1, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for azelastine hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20070104884 | Start Trial |
| Lithuania | 2486942 | Start Trial |
| Spain | 2617255 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for azelastine hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1519731 | 13C0067 | France | Start Trial | 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 | Start Trial | PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218 |
| 1519731 | 92269 | Luxembourg | Start Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| >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.
ISSN: 2162-2639
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