FAMCICLOVIR Drug Patent Profile
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When do Famciclovir patents expire, and what generic alternatives are available?
Famciclovir is a drug marketed by Apotex, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd V, Hikma, Macleods Pharms Ltd, Natco Pharma, and Teva Pharms. and is included in eight NDAs.
The generic ingredient in FAMCICLOVIR is famciclovir. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the famciclovir profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Famciclovir
A generic version of FAMCICLOVIR was approved as famciclovir by TEVA PHARMS on August 24th, 2007.
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Questions you can ask:
- What is the 5 year forecast for FAMCICLOVIR?
- What are the global sales for FAMCICLOVIR?
- What is Average Wholesale Price for FAMCICLOVIR?
Summary for FAMCICLOVIR
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 137 |
| Clinical Trials: | 19 |
| Patent Applications: | 4,159 |
| Drug Prices: | Drug price information for FAMCICLOVIR |
| DailyMed Link: | FAMCICLOVIR at DailyMed |
Recent Clinical Trials for FAMCICLOVIR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Queen Mary University of London | Phase 2 |
| EMS | Phase 3 |
| House Clinic, Inc. | Phase 3 |
Pharmacology for FAMCICLOVIR
| Drug Class | Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor |
| Mechanism of Action | DNA Polymerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for FAMCICLOVIR
Paragraph IV (Patent) Challenges for FAMCICLOVIR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FAMVIR | Tablets | famciclovir | 125 mg, 250 mg and 500 mg | 020363 | 1 | 2004-12-28 |
US Patents and Regulatory Information for FAMCICLOVIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | FAMCICLOVIR | famciclovir | TABLET;ORAL | 091480-001 | Jul 22, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | FAMCICLOVIR | famciclovir | TABLET;ORAL | 201022-003 | Jan 12, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms | FAMCICLOVIR | famciclovir | TABLET;ORAL | 077487-003 | Aug 24, 2007 | AB | RX | No | 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 |
