Vardenafil hydrochloride - Generic Drug Details
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What are the generic sources for vardenafil hydrochloride and what is the scope of freedom to operate?
Vardenafil hydrochloride
is the generic ingredient in three branded drugs marketed by Bayer Hlthcare, Alembic, Macleods Pharms Ltd, Crossmedika Sa, Stevens J, Teva Pharms, and Zydus Pharms, and is included in ten NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Vardenafil hydrochloride has one hundred and seven patent family members in forty-three countries.
There are six drug master file entries for vardenafil hydrochloride. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for vardenafil hydrochloride
International Patents: | 107 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 7 |
NDAs: | 10 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 82 |
Patent Applications: | 21 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for vardenafil hydrochloride |
What excipients (inactive ingredients) are in vardenafil hydrochloride? | vardenafil hydrochloride excipients list |
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 |
Generic filers with tentative approvals for VARDENAFIL HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL |
⤷ Sign Up | ⤷ Sign Up | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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
Expired US Patents for vardenafil hydrochloride
International Patents for vardenafil hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 200707320 | Pharmaceutical forms with improved pharmacokinetic properties | ⤷ Sign Up |
Costa Rica | 20130381 | FORMAS FARMACÉUTICAS CON PROPIEDADES FARMACOCINÉTICAS MEJORADAS | ⤷ Sign Up |
Cyprus | 1112460 | ⤷ Sign Up | |
Croatia | P20131002 | LIJEKOVI KOJI SADRŽAVAJU VARDENAFIL HIDROKLORID TRIHIDRAT (PHARMACEUTICAL COMPOSITIONS CONTAINING VARDENAFIL HYDROCHLORIDE TRIHYDRATE) | ⤷ Sign Up |
Israel | 232538 | ⤷ Sign Up | |
Japan | 5173113 | ⤷ Sign Up | |
Norway | 20050578 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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