Pulmicort Flexhaler is a drug owned by Cheplapharm Arzneimittel Gmbh. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 08, 2018. Details of Pulmicort Flexhaler's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6142145 | Inhalation device |
May, 2018
(8 years ago) |
Expired
|
| US7143764 | Inhalation device |
Mar, 2018
(8 years ago) |
Expired
|
| US6027714 | Formulation for inhalation |
Jan, 2018
(8 years ago) |
Expired
|
| US6287540 | Formulation for inhalation |
Jan, 2018
(8 years ago) |
Expired
|
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Pulmicort Flexhaler and ongoing
litigations to
help you estimate the early arrival of Pulmicort Flexhaler generic.
Pulmicort Flexhaler's Litigations
Pulmicort Flexhaler been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 31, 2005, against patent number US7143764. The petitioner , challenged the validity of this patent, with ALLAN DAGSLAND et al as the respondent. Click below to track the latest information on how companies are challenging Pulmicort Flexhaler's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7143764 | May, 2005 |
Decision
(31 Mar, 2006) | ALLAN DAGSLAND et al | |
US patents provide insights into the exclusivity only within the United States, but
Pulmicort Flexhaler is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Pulmicort Flexhaler's family patents as well as insights into
ongoing legal events
on those patents.
Pulmicort Flexhaler's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Pulmicort Flexhaler:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Pulmicort Flexhaler's generic launch date based on the expiry of its last outstanding patent is estimated to be May 08, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pulmicort Flexhaler Generic API suppliers:
Budesonide is the generic name for the brand Pulmicort Flexhaler. 22 different companies have already filed for the generic of Pulmicort Flexhaler, with Sandoz having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pulmicort Flexhaler's generic
Alternative Brands for Pulmicort Flexhaler
Pulmicort Flexhaler which is used for long-term management of asthma in adults and children aged 6 and older, including those needing oral corticosteroids., has several other brand drugs using the same active ingredient (Budesonide). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |||||
|---|---|---|---|---|---|---|
| Astrazeneca |
| |||||
| Astrazeneca Ab |
| |||||
| Calliditas |
| |||||
| Padagis Us |
| |||||
| Salix |
| |||||
| Sun Pharm Inds Inc |
| |||||
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Budesonide, Pulmicort Flexhaler's active ingredient. Check the complete list of approved generic manufacturers for Pulmicort Flexhaler
About Pulmicort Flexhaler
Pulmicort Flexhaler is a drug owned by Cheplapharm Arzneimittel Gmbh. It is used for long-term management of asthma in adults and children aged 6 and older, including those needing oral corticosteroids. Pulmicort Flexhaler uses Budesonide as an active ingredient. Pulmicort Flexhaler was launched by Cheplapharm in 2006.
Approval Date:
Pulmicort Flexhaler was approved by FDA for market use on 12 July, 2006.
Active Ingredient:
Pulmicort Flexhaler uses Budesonide as the active ingredient. Check out other Drugs and Companies using Budesonide ingredient
Treatment:
Pulmicort Flexhaler is used for long-term management of asthma in adults and children aged 6 and older, including those needing oral corticosteroids.
Dosage:
Pulmicort Flexhaler is available in powder, metered form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.16MG/INH | POWDER, METERED | Prescription | INHALATION |
| 0.08MG/INH | POWDER, METERED | Prescription | INHALATION |