Albuterol sulfate; ipratropium bromide - Generic Drug Details
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What are the generic drug sources for albuterol sulfate; ipratropium bromide and what is the scope of freedom to operate?
Albuterol sulfate; ipratropium bromide
is the generic ingredient in four branded drugs marketed by Boehringer Ingelheim, Apotex Inc, Cipla, Fosun Pharma, Luoxin Aurovitas, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, Watson Labs Teva, and Norvium Bioscience, and is included in twelve NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Albuterol sulfate; ipratropium bromide has one hundred and eighteen patent family members in thirty-six countries.
Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for albuterol sulfate; ipratropium bromide
International Patents: | 118 |
US Patents: | 6 |
Tradenames: | 4 |
Applicants: | 11 |
NDAs: | 12 |
Finished Product Suppliers / Packagers: | 15 |
Clinical Trials: | 4 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for albuterol sulfate; ipratropium bromide |
DailyMed Link: | albuterol sulfate; ipratropium bromide at DailyMed |
Recent Clinical Trials for albuterol sulfate; ipratropium bromide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
James J. Peters Veterans Affairs Medical Center | Phase 2 |
University of Texas Southwestern Medical Center | Phase 4 |
Dey | Phase 3 |
See all albuterol sulfate; ipratropium bromide clinical trials
Generic filers with tentative approvals for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION |
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 albuterol sulfate; ipratropium bromide
Drug Class | Anticholinergic beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for albuterol sulfate; ipratropium bromide
Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
COMBIVENT RESPIMAT | Inhalation Aerosol | albuterol sulfate; ipratropium bromide | 100 mcg/20 mcg per actuation | 021747 | 1 | 2023-03-30 |
US Patents and Regulatory Information for albuterol sulfate; ipratropium bromide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | COMBIVENT RESPIMAT | albuterol sulfate; ipratropium bromide | SPRAY, METERED;INHALATION | 021747-001 | Oct 7, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Boehringer Ingelheim | COMBIVENT RESPIMAT | albuterol sulfate; ipratropium bromide | SPRAY, METERED;INHALATION | 021747-001 | Oct 7, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Teva Pharms | ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 076724-001 | Dec 31, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Norvium Bioscience | DUONEB | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 020950-001 | Mar 21, 2001 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Boehringer Ingelheim | COMBIVENT RESPIMAT | albuterol sulfate; ipratropium bromide | SPRAY, METERED;INHALATION | 021747-001 | Oct 7, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 albuterol sulfate; ipratropium bromide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | COMBIVENT RESPIMAT | albuterol sulfate; ipratropium bromide | SPRAY, METERED;INHALATION | 021747-001 | Oct 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | COMBIVENT RESPIMAT | albuterol sulfate; ipratropium bromide | SPRAY, METERED;INHALATION | 021747-001 | Oct 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | COMBIVENT RESPIMAT | albuterol sulfate; ipratropium bromide | SPRAY, METERED;INHALATION | 021747-001 | Oct 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | COMBIVENT | albuterol sulfate; ipratropium bromide | AEROSOL, METERED;INHALATION | 020291-001 | Oct 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | COMBIVENT RESPIMAT | albuterol sulfate; ipratropium bromide | SPRAY, METERED;INHALATION | 021747-001 | Oct 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for albuterol sulfate; ipratropium bromide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2651190 | PULVERISATEUR ET PROCEDE DE PULVERISATION D'UN FLUIDE (ATOMIZER AND METHOD OF ATOMIZING FLUID) | ⤷ Sign Up |
Ukraine | 85865 | ПРИСТРІЙ ДЛЯ КРІПЛЕННЯ СТРУМИННОЇ ДЕТАЛІ;устройство для крепления струйной детали (Device for fastening of fluidic component) | ⤷ Sign Up |
Brazil | 0313816 | Dispositivo de bloqueio para um mecanismo tensor de bloqueio com saìda ativada à mola | ⤷ Sign Up |
Japan | 4411209 | ⤷ Sign Up | |
Peru | 20040387 | DISPOSITIVO BLOQUEADOR PARA UN MECANISMO TENSOR DE BLOQUEO CON UNA TOMA DE FUERZA ACCIONADA POR RESORTE | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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