DrugPatentWatch Database Preview
LAZANDA Drug Profile
» See Plans and Pricing
Which patents cover Lazanda, and when can generic versions of Lazanda launch?
Lazanda is a drug marketed by Btcp Pharma and is included in one NDA. There are five patents protecting this drug.
This drug has sixty-two patent family members in thirty countries.
The generic ingredient in LAZANDA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
US ANDA Litigation and Generic Entry Outlook for Lazanda
A generic version of LAZANDA was approved as fentanyl citrate by HOSPIRA on January 12th, 1985.
Summary for LAZANDA
| International Patents: | 62 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 26 |
| Clinical Trials: | 5 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LAZANDA |
| DailyMed Link: | LAZANDA at DailyMed |
Recent Clinical Trials for LAZANDA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Diego | Phase 2 |
| Depomed | Phase 4 |
| Defense and Veterans Center for Integrative Pain Management | Phase 4 |
US Patents and Regulatory Information for LAZANDA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-001 | Jun 30, 2011 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-003 | Dec 21, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-001 | Jun 30, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >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 LAZANDA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-001 | Jun 30, 2011 | Start Trial | Start Trial |
| Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-002 | Jun 30, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LAZANDA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| United Kingdom | 0300531 | Start Trial |
| San Marino | T201600352 | Start Trial |
| Portugal | 2670674 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LAZANDA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0836511 | CA 2006 00019 | Denmark | Start Trial | PRODUCT NAME: FENTANYL HYDROCHLORID |
| 1635783 | 132014902242643 | Italy | Start Trial | PRODUCT NAME: FENTANIL IN QUALSIASI FORMA PROTETTA DAL BREVETTO DI BASE(PECFENT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/10/644/001-004, 20100831 |
| 0836511 | 122006000022 | Germany | Start Trial | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
