PROVENTIL-HFA Drug Patent Profile
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When do Proventil-hfa patents expire, and what generic alternatives are available?
Proventil-hfa is a drug marketed by Kindeva and is included in one NDA.
The generic ingredient in PROVENTIL-HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Proventil-hfa
A generic version of PROVENTIL-HFA was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5th, 1989.
Summary for PROVENTIL-HFA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 81 |
Clinical Trials: | 19 |
Patent Applications: | 5,573 |
Formulation / Manufacturing: | see details |
DailyMed Link: | PROVENTIL-HFA at DailyMed |
Recent Clinical Trials for PROVENTIL-HFA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
AstraZeneca | Phase 2 |
University Medical Center of Southern Nevada | N/A |
West Penn Allegheny Health System | Phase 4 |
Pharmacology for PROVENTIL-HFA
Drug Class | beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists |
Paragraph IV (Patent) Challenges for PROVENTIL-HFA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PROVENTIL-HFA | Inhalation Aerosol | albuterol sulfate | 0.09 mg base per actuation | 020503 | 1 | 2015-05-20 |
US Patents and Regulatory Information for PROVENTIL-HFA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | AB1 | RX | Yes | 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 |
Expired US Patents for PROVENTIL-HFA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROVENTIL-HFA
See the table below for patents covering PROVENTIL-HFA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | H02200627 | MEDICAL AEROSOL PREPARATION | ⤷ Try a Trial |
Canada | 2004598 | AEROSOLS MEDICINAUX (MEDICINAL AEROSOL FORMULATIONS) | ⤷ Try a Trial |
Spain | 2045470 | ⤷ Try a Trial | |
Denmark | 0562032 | ⤷ Try a Trial | |
New Zealand | 243056 | AEROSOL FORMULATION CONTAINING A MEDICAMENT, TETRAFLUOROETHANE AND ISOPROPYL MYRISTATE | ⤷ Try a Trial |
South Africa | 9110143 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |