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Serving leading biopharmaceutical companies globally:

Chubb
Fish and Richardson
Mallinckrodt
Boehringer Ingelheim
Covington
US Department of Justice
UBS
QuintilesIMS
Healthtrust
Cipla

Generated: January 16, 2018

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Albuterol sulfate - Generic Drug Details

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What are the generic sources for albuterol sulfate and what is the scope of albuterol sulfate patent protection?

Albuterol sulfate
is the generic ingredient in fifteen branded drugs marketed by Teva Branded Pharm, 3m Drug Delivery, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharma Global, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, G And W Labs Inc, Mova, Teva, Vintage, Vistapharm, Mylan, Muro, Dava Pharms Inc, Am Therap, Pliva, Sandoz, Sun Pharm Industries, Ucb Inc, Warner Chilcott, Boehringer Ingelheim, Cipla Ltd, Sandoz Inc, and Watson Labs Teva, and is included in eighty-five NDAs. There are fifty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate has four hundred and thirty-three patent family members in forty-two countries.

There are thirty-seven drug master file entries for albuterol sulfate. Forty-five suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for albuterol sulfate
Pharmacology for albuterol sulfate
Tentative approvals for ALBUTEROL SULFATE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ SubscribeEQ 0.083% BASE;0.017%SOLUTION;INHALATION

US Patents and Regulatory Information for albuterol sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dava Pharms Inc VOSPIRE ER albuterol sulfate TABLET, EXTENDED RELEASE;ORAL 076130-003 Sep 26, 2002 AB RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Watson Labs ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 077772-001 Sep 25, 2007 AN RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Schering PROVENTIL albuterol sulfate SOLUTION;INHALATION 019243-001 Jan 14, 1987 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
3m Drug Delivery PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996 BX RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 BX RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Schering PROVENTIL albuterol sulfate TABLET;ORAL 017853-001 May 7, 1982 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mova ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074302-001 Sep 30, 1994 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072765-001 Aug 28, 1991 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for albuterol sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Muro VOLMAX albuterol sulfate TABLET, EXTENDED RELEASE;ORAL 019604-001 Dec 23, 1992 ➤ Subscribe ➤ Subscribe
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-002 Jul 10, 1986 ➤ Subscribe ➤ Subscribe
Muro VOLMAX albuterol sulfate TABLET, EXTENDED RELEASE;ORAL 019604-001 Dec 23, 1992 ➤ Subscribe ➤ Subscribe
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ➤ Subscribe ➤ Subscribe
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ➤ Subscribe ➤ Subscribe
Schering PROVENTIL albuterol sulfate SOLUTION;INHALATION 019243-001 Jan 14, 1987 ➤ Subscribe ➤ Subscribe
Glaxosmithkline VENTOLIN ROTACAPS albuterol sulfate CAPSULE;INHALATION 019489-001 May 4, 1988 ➤ Subscribe ➤ Subscribe
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-002 Jul 10, 1986 ➤ Subscribe ➤ Subscribe
Schering PROVENTIL albuterol sulfate SYRUP;ORAL 018062-001 Jan 19, 1983 ➤ Subscribe ➤ Subscribe
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-001 Jul 10, 1986 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for albuterol sulfate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,533,111 Dose counters for inhalers, inhalers and methods of assembly thereof ➤ Subscribe
6,030,682 Container for aerosol formulation ➤ Subscribe
9,108,010 Dose counters for inhalers, inhalers and methods of assembly thereof ➤ Subscribe
6,655,381 Pre-metered dose magazine for breath-actuated dry powder inhaler ➤ Subscribe
6,743,413 Suspension aerosol formulations ➤ Subscribe
6,656,453 Medicaments ➤ Subscribe
9,174,013 Dose counters for inhalers, inhalers and methods of assembly thereof ➤ Subscribe
9,737,674 Dose counters for inhalers, inhalers and methods of assembly thereof ➤ Subscribe
9,526,851 Dose counters for inhalers, inhalers and methods of assembly thereof ➤ Subscribe
9,526,850 Dose counters for inhalers, inhalers and methods of assembly thereof ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for albuterol sulfate

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Serving leading biopharmaceutical companies globally:

Accenture
Federal Trade Commission
Colorcon
Moodys
Deloitte
Cantor Fitzgerald
Healthtrust
UBS
Mallinckrodt

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 verifification 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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