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. Eleven 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.
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Questions you can ask:
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Summary for VARDENAFIL HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 82 |
| Patent Applications: | 17 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VARDENAFIL HYDROCHLORIDE |
| DailyMed Link: | VARDENAFIL HYDROCHLORIDE at DailyMed |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms | VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 091347-001 | May 3, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 208960-003 | Oct 31, 2018 | AB | RX | 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 |
