FLUNISOLIDE - Generic Drug Details
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What are the generic sources for flunisolide and what is the scope of freedom to operate?
Flunisolide
is the generic ingredient in five branded drugs marketed by Roche Palo, Mylan Speciality Lp, Apotex, Bausch, Riconpharma Llc, Rising, Ivax Res, and Teva Branded Pharm, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.There are twelve drug master file entries for flunisolide. Two suppliers are listed for this compound.
Summary for FLUNISOLIDE
| US Patents: | 0 |
| Tradenames: | 5 |
| Applicants: | 8 |
| NDAs: | 8 |
| Drug Master File Entries: | 12 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 4 |
| Patent Applications: | 7,258 |
| Drug Prices: | Drug price trends for FLUNISOLIDE |
| Drug Sales Revenues: | Drug sales revenues for FLUNISOLIDE |
| What excipients (inactive ingredients) are in FLUNISOLIDE? | FLUNISOLIDE excipients list |
| DailyMed Link: | FLUNISOLIDE at DailyMed |
Recent Clinical Trials for FLUNISOLIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Meda Pharmaceuticals | N/A |
| University of Louisville | N/A |
| GlaxoSmithKline | Phase 3 |
Pharmacology for FLUNISOLIDE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for FLUNISOLIDE
US Patents and Regulatory Information for FLUNISOLIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | FLUNISOLIDE | flunisolide | SPRAY, METERED;NASAL | 074805-001 | Feb 20, 2002 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | FLUNISOLIDE | flunisolide | SPRAY, METERED;NASAL | 077704-001 | Aug 3, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Speciality Lp | AEROSPAN HFA | flunisolide | AEROSOL, METERED;INHALATION | 021247-001 | Jan 27, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | FLUNISOLIDE | flunisolide | SPRAY, METERED;NASAL | 077436-001 | Aug 9, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roche Palo | AEROBID | flunisolide | AEROSOL, METERED;INHALATION | 018340-001 | Aug 17, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ivax Res | NASALIDE | flunisolide | SPRAY, METERED;NASAL | 018148-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Branded Pharm | NASAREL | flunisolide | SPRAY, METERED;NASAL | 020409-001 | Mar 8, 1995 | DISCN | No | No | ⤷ 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 FLUNISOLIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Roche Palo | AEROBID | flunisolide | AEROSOL, METERED;INHALATION | 018340-001 | Aug 17, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| Ivax Res | NASALIDE | flunisolide | SPRAY, METERED;NASAL | 018148-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Branded Pharm | NASAREL | flunisolide | SPRAY, METERED;NASAL | 020409-001 | Mar 8, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Branded Pharm | NASAREL | flunisolide | SPRAY, METERED;NASAL | 020409-001 | Mar 8, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Branded Pharm | NASAREL | flunisolide | SPRAY, METERED;NASAL | 020409-001 | Mar 8, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Speciality Lp | AEROSPAN HFA | flunisolide | AEROSOL, METERED;INHALATION | 021247-001 | Jan 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Speciality Lp | AEROSPAN HFA | flunisolide | AEROSOL, METERED;INHALATION | 021247-001 | Jan 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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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