VARDENAFIL HYDROCHLORIDE Drug Patent Profile
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Which patents cover Vardenafil Hydrochloride, and when can generic versions of Vardenafil Hydrochloride launch?
Vardenafil Hydrochloride is a drug marketed by Alembic, Macleods Pharms Ltd, Crossmedika Sa, Stevens J, Teva Pharms, and Zydus Pharms. and is included in eight NDAs.
The generic ingredient in VARDENAFIL HYDROCHLORIDE is vardenafil hydrochloride. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Vardenafil Hydrochloride
A generic version of VARDENAFIL HYDROCHLORIDE was approved as vardenafil hydrochloride by TEVA PHARMS on May 3rd, 2012.
Summary for VARDENAFIL HYDROCHLORIDE
Recent Clinical Trials for VARDENAFIL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AriBio Co., Ltd. | Phase 3 |
| Respira Therapeutics, Inc. | Phase 1 |
| Johns Hopkins University | Phase 1/Phase 2 |
Pharmacology for VARDENAFIL HYDROCHLORIDE
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for VARDENAFIL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for VARDENAFIL HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| STAXYN | Orally Disintegrating Tablets | vardenafil hydrochloride | 10 mg | 200179 | 1 | 2011-12-22 |
| 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 VARDENAFIL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 208324-001 | Nov 16, 2018 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms | VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 091347-001 | May 3, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 208960-003 | Oct 31, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Crossmedika Sa | VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 209057-001 | Oct 31, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
