FLOLAN Drug Patent Profile
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When do Flolan patents expire, and when can generic versions of Flolan launch?
Flolan is a drug marketed by Glaxosmithkline Llc and is included in one NDA.
The generic ingredient in FLOLAN is epoprostenol sodium. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Flolan
A generic version of FLOLAN was approved as epoprostenol sodium by SUN PHARM on January 15th, 2021.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for FLOLAN?
- What are the global sales for FLOLAN?
- What is Average Wholesale Price for FLOLAN?
Summary for FLOLAN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 33 |
| Clinical Trials: | 16 |
| Patent Applications: | 1,769 |
| Drug Prices: | Drug price information for FLOLAN |
| What excipients (inactive ingredients) are in FLOLAN? | FLOLAN excipients list |
| DailyMed Link: | FLOLAN at DailyMed |
Recent Clinical Trials for FLOLAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Health Network, Toronto | Phase 4 |
| GlaxoSmithKline | Phase 4 |
| Rune Rasmussen | Phase 2 |
US Patents and Regulatory Information for FLOLAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-001 | Sep 20, 1995 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-002 | Sep 20, 1995 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >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 FLOLAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-001 | Sep 20, 1995 | 4,883,812 | ⤷ Start Trial |
| Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-001 | Sep 20, 1995 | 4,335,139 | ⤷ Start Trial |
| Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-002 | Sep 20, 1995 | 4,539,333 | ⤷ Start Trial |
| Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-001 | Sep 20, 1995 | 4,539,333 | ⤷ Start Trial |
| Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-002 | Sep 20, 1995 | 4,883,812 | ⤷ Start Trial |
| Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-001 | Sep 20, 1995 | 4,338,325 | ⤷ Start Trial |
| Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-002 | Sep 20, 1995 | 4,335,139 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FLOLAN
See the table below for patents covering FLOLAN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 365926 | ⤷ Start Trial | |
| Austria | 4411 | ⤷ Start Trial | |
| Austria | A363479 | ⤷ Start Trial | |
| Australia | 4704279 | ⤷ Start Trial | |
| Australia | 525695 | ⤷ Start Trial | |
| Belgium | 876296 | ⤷ Start Trial | |
| Canada | 1141661 | PREPARATIONS PHARMACEUTIQUES CONTENANT DES PROSTAGLANDINES (PHARMACEUTICAL FORMULATIONS CONTAINING PROSTAGLANDIN COMPOUNDS) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
DrugChatter Q&A for FLOLAN
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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