PENCICLOVIR Drug Patent Profile
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Which patents cover Penciclovir, and when can generic versions of Penciclovir launch?
Penciclovir is a drug marketed by Teva Pharms Usa and Torrent and is included in two NDAs.
The generic ingredient in PENCICLOVIR 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 Penciclovir
A generic version of PENCICLOVIR was approved as penciclovir by TEVA PHARMS USA on November 9th, 2022.
Summary for PENCICLOVIR
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 3 |
| Patent Applications: | 4,669 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PENCICLOVIR |
| What excipients (inactive ingredients) are in PENCICLOVIR? | PENCICLOVIR excipients list |
| DailyMed Link: | PENCICLOVIR at DailyMed |
Recent Clinical Trials for PENCICLOVIR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Squarex, LLC | Phase 2 |
| EMS | Phase 3 |
| Novartis | Phase 4 |
Pharmacology for PENCICLOVIR
| Drug Class | Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor |
| Mechanism of Action | DNA Polymerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PENCICLOVIR
US Patents and Regulatory Information for PENCICLOVIR
PENCICLOVIR is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting PENCICLOVIR
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | PENCICLOVIR | penciclovir | CREAM;TOPICAL | 212710-001 | Nov 9, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Torrent | PENCICLOVIR | penciclovir | CREAM;TOPICAL | 216981-001 | Aug 7, 2023 | 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 |
