LEVITRA Drug Patent Profile
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Which patents cover Levitra, and what generic alternatives are available?
Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges.
This drug has fifty-four patent family members in thirty-one countries.
The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Levitra
A generic version of LEVITRA was approved as vardenafil hydrochloride by TEVA PHARMS on May 3rd, 2012.
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Summary for LEVITRA
| International Patents: | 54 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 26 |
| Patent Applications: | 4,858 |
| Drug Prices: | Drug price information for LEVITRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEVITRA |
| What excipients (inactive ingredients) are in LEVITRA? | LEVITRA excipients list |
| DailyMed Link: | LEVITRA at DailyMed |
Recent Clinical Trials for LEVITRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Respira Therapeutics, Inc. | Phase 1 |
| Tritech Biopharmaceuticals Co., Ltd. | Phase 1/Phase 2 |
| A2 Healthcare Taiwan Corporation | Phase 1/Phase 2 |
Paragraph IV (Patent) Challenges for LEVITRA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LEVITRA | Tablets | vardenafil hydrochloride | 2.5 mg | 021400 | 1 | 2009-09-04 |
| LEVITRA | Tablets | vardenafil hydrochloride | 5 mg and 10 mg | 021400 | 1 | 2009-07-10 |
| LEVITRA | Tablets | vardenafil hydrochloride | 20 mg | 021400 | 1 | 2009-03-05 |
US Patents and Regulatory Information for LEVITRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-003 | Aug 19, 2003 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | DISCN | Yes | 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 LEVITRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-002 | Aug 19, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-002 | Aug 19, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEVITRA
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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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