TAMIFLU Drug Patent Profile
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When do Tamiflu patents expire, and when can generic versions of Tamiflu launch?
Tamiflu is a drug marketed by Roche and is included in two NDAs.
The generic ingredient in TAMIFLU is oseltamivir phosphate. There are eight drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tamiflu
A generic version of TAMIFLU was approved as oseltamivir phosphate by NATCO on August 3rd, 2016.
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Summary for TAMIFLU
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 96 |
| Clinical Trials: | 71 |
| Patent Applications: | 2,963 |
| Drug Prices: | Drug price information for TAMIFLU |
| Drug Sales Revenues: | Drug sales revenues for TAMIFLU |
| What excipients (inactive ingredients) are in TAMIFLU? | TAMIFLU excipients list |
| DailyMed Link: | TAMIFLU at DailyMed |
Recent Clinical Trials for TAMIFLU
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Hospital of Philadelphia | Phase 4 |
| Genentech, Inc. | Phase 4 |
| Weill Medical College of Cornell University | Phase 4 |
Pharmacology for TAMIFLU
| Drug Class | Neuraminidase Inhibitor |
| Mechanism of Action | Neuraminidase Inhibitors |
Paragraph IV (Patent) Challenges for TAMIFLU
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TAMIFLU | for Oral Suspension | oseltamivir phosphate | 6 mg/mL | 021246 | 1 | 2015-06-18 |
| TAMIFLU | Capsules | oseltamivir phosphate | 30 mg and 45 mg | 021087 | 1 | 2011-08-02 |
| TAMIFLU | Capsules | oseltamivir phosphate | 75 mg | 021087 | 1 | 2010-11-15 |
US Patents and Regulatory Information for TAMIFLU
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-003 | Jul 2, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-002 | Mar 21, 2011 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-002 | Jul 2, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-001 | Oct 27, 1999 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-001 | Dec 14, 2000 | 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 TAMIFLU
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-001 | Dec 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-002 | Mar 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-003 | Jul 2, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-002 | Jul 2, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-002 | Jul 2, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-001 | Oct 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TAMIFLU
See the table below for patents covering TAMIFLU around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Chile | 2004001291 | ⤷ Sign Up | |
| Hong Kong | 1088594 | ⤷ Sign Up | |
| Poland | 322000 | ⤷ Sign Up | |
| Hong Kong | 1120494 | ⤷ Sign Up | |
| Germany | 69635231 | ⤷ Sign Up | |
| Germany | 69607704 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TAMIFLU
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0759917 | 0290024-9 | Sweden | ⤷ Sign Up | |
| 0759917 | CA 2002 00027 | Denmark | ⤷ Sign Up | |
| 0759917 | 90991 | Luxembourg | ⤷ Sign Up | |
| 0759917 | SPC031/2002 | Ireland | ⤷ Sign Up | SPC031/2002: 20021107, EXPIRES: 20160226 |
| 0759917 | 38/2002 | Austria | ⤷ Sign Up | PRODUCT NAME: OSELTAMIVIR PHOSPHAT; REGISTRATION NO/DATE: EU/1/02/222/001 EU/1/02/222/002 20020620 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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