FLUTICASONE PROPIONATE Drug Patent Profile
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When do Fluticasone Propionate patents expire, and what generic alternatives are available?
Fluticasone Propionate is a drug marketed by Cosette, Encube, Fougera Pharms, Nesher Pharms, Padagis Israel, Glenmark Pharms Ltd, Bright, Taro Pharm Inds, Apotex, Apotex Inc, Chartwell Rx, Hikma, and Teva Pharms Usa. and is included in twenty-one NDAs.
The generic ingredient in FLUTICASONE PROPIONATE is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fluticasone Propionate
A generic version of FLUTICASONE PROPIONATE was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17th, 2020.
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Questions you can ask:
- What is the 5 year forecast for FLUTICASONE PROPIONATE?
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- What is Average Wholesale Price for FLUTICASONE PROPIONATE?
Summary for FLUTICASONE PROPIONATE
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 73 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 365 |
| Patent Applications: | 5,456 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FLUTICASONE PROPIONATE |
| Drug Sales Revenues: | Drug sales revenues for FLUTICASONE PROPIONATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FLUTICASONE PROPIONATE |
| What excipients (inactive ingredients) are in FLUTICASONE PROPIONATE? | FLUTICASONE PROPIONATE excipients list |
| DailyMed Link: | FLUTICASONE PROPIONATE at DailyMed |
See drug prices for FLUTICASONE PROPIONATE
Recent Clinical Trials for FLUTICASONE PROPIONATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eurofarma Laboratorios S.A. | Phase 3 |
| Humanis Saglık Anonim Sirketi | Phase 1 |
| Emory University | Phase 3 |
Pharmacology for FLUTICASONE PROPIONATE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for FLUTICASONE PROPIONATE
Paragraph IV (Patent) Challenges for FLUTICASONE PROPIONATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FLOVENT HFA | Inhalation Aerosol | fluticasone propionate | 0.22 mg/inh | 021433 | 1 | 2021-10-29 |
| FLOVENT HFA | Inhalation Aerosol | fluticasone propionate | 0.11 mg/inh | 021433 | 1 | 2016-12-23 |
| CUTIVATE | Lotion | fluticasone propionate | 0.05% | 021152 | 1 | 2008-07-28 |
US Patents and Regulatory Information for FLUTICASONE PROPIONATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cosette | FLUTICASONE PROPIONATE | fluticasone propionate | CREAM;TOPICAL | 077055-001 | Jun 30, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 207957-001 | May 26, 2016 | OTC | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms Usa | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 213948-002 | Dec 13, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Padagis Israel | FLUTICASONE PROPIONATE | fluticasone propionate | LOTION;TOPICAL | 091553-001 | Jul 30, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Nesher Pharms | FLUTICASONE PROPIONATE | fluticasone propionate | CREAM;TOPICAL | 076865-001 | Sep 10, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Taro Pharm Inds | FLUTICASONE PROPIONATE | fluticasone propionate | OINTMENT;TOPICAL | 077145-001 | Jun 14, 2005 | 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 |
