DENAVIR Drug Patent Profile
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When do Denavir patents expire, and when can generic versions of Denavir launch?
Denavir is a drug marketed by Mylan and is included in one NDA.
The generic ingredient in DENAVIR is penciclovir. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the penciclovir profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Denavir
A generic version of DENAVIR was approved as penciclovir by TEVA PHARMS USA on November 9th, 2022.
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Summary for DENAVIR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,952 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DENAVIR |
| What excipients (inactive ingredients) are in DENAVIR? | DENAVIR excipients list |
| DailyMed Link: | DENAVIR at DailyMed |
Recent Clinical Trials for DENAVIR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Squarex, LLC | Phase 2 |
Pharmacology for DENAVIR
| Drug Class | Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor |
| Mechanism of Action | DNA Polymerase Inhibitors |
US Patents and Regulatory Information for DENAVIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | AB | RX | Yes | Yes | ⤷ 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 DENAVIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DENAVIR
See the table below for patents covering DENAVIR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 972688 | ⤷ Sign Up | |
| Japan | 2519882 | ⤷ Sign Up | |
| Australia | 697290 | ⤷ Sign Up | |
| Denmark | 0804199 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DENAVIR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0141927 | 97C0033 | Belgium | ⤷ Sign Up | PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: 981 IS 110 F 7; 19970206; FIRST REGISTRATION: GB 10592/0078 19960228 |
| 0182024 | SPC/GB94/002 | United Kingdom | ⤷ Sign Up | SPC/GB94/002: 20050910, EXPIRES: 20081209 |
| 0141927 | SPC/GB96/014 | United Kingdom | ⤷ Sign Up | SPC/GB96/014: 20040810, EXPIRES: 20090809 |
| 0296560 | 98C0015 | Belgium | ⤷ Sign Up | PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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