PROVENTIL-HFA Drug Patent Profile
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Which patents cover Proventil-hfa, and when can generic versions of Proventil-hfa launch?
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-five 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.
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Summary for PROVENTIL-HFA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 19 |
| Patent Applications: | 5,404 |
| 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 |
| Asthma Management Systems | Phase 4 |
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 | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| European Patent Office | 0960830 | ⤷ Sign Up | |
| European Patent Office | 0499344 | Formulations d'aérosols à usage médical comprenant salbutamol (Medicinal aerosol formulations comprising salbutamol) | ⤷ Sign Up |
| Japan | 2786493 | ⤷ Sign Up | |
| Mexico | 9203480 | FORMULACIONES MEDICINALES EN AEREOSOL. | ⤷ Sign Up |
| European Patent Office | 0995434 | ⤷ Sign Up | |
| European Patent Office | 0673857 | Dispositif d'émission d'un aérosol (Device for delivering an aerosol) | ⤷ Sign Up |
| South Africa | 8909290 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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