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LYRICA CR Drug Profile
Which patents cover Lyrica Cr, and what generic alternatives are available?
Lyrica Cr is a drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this drug and four Paragraph IV challenges.
This drug has one hundred and four patent family members in forty-five countries.
The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for LYRICA CR
| International Patents: | 104 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 85 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LYRICA CR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LYRICA CR |
| DailyMed Link: | LYRICA CR at DailyMed |
Recent Clinical Trials for LYRICA CR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Missouri-Columbia | Phase 2/Phase 3 |
| University of Utah | Phase 4 |
| University of Missouri-Columbia | Phase 3 |
Recent Litigation for LYRICA CR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Pfizer Inc. v. Alphapharm Pty Ltd. | 2010-03-12 |
| Pfizer Inc. v. Teva Pharmaceuticals USA Inc. | 2009-04-29 |
| Pfizer Inc. v. Lupin Ltd. | 2009-04-29 |
Paragraph IV (Patent) Challenges for LYRICA CR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LYRICA CR | TABLET, EXTENDED RELEASE;ORAL | pregabalin | 209501 | 2018-02-02 |
| LYRICA CR | TABLET, EXTENDED RELEASE;ORAL | pregabalin | 209501 | 2018-01-29 |
US Patents and Regulatory Information for LYRICA CR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pf Prism Cv | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-001 | Oct 11, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Pf Prism Cv | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Pf Prism Cv | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-001 | Oct 11, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pf Prism Cv | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-001 | Oct 11, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Pf Prism Cv | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-002 | Oct 11, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Pf Prism Cv | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Pf Prism Cv | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-002 | Oct 11, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for LYRICA CR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 641330 | Start Trial |
| Japan | 3693258 | Start Trial |
| New Zealand | 567414 | Start Trial |
| Japan | H07508288 | Start Trial |
| European Patent Office | 0641330 | Start Trial |
| Serbia | 20080181 | Start Trial |
| Denmark | 0641330 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LYRICA CR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0934061 | PA2004017 | Lithuania | Start Trial | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS) |
| 0934061 | PA2004017,C0934061 | Lithuania | Start Trial | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725 |
| 0641330 | 27/2004 | Austria | Start Trial | PRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706 |
| 0641330 | CR 2004 00036 | Denmark | Start Trial | PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706 |
| 0641330 | 91112 | Luxembourg | Start Trial | 91112, EXPIRES: 20180518 |
| 0641330 | CA 2004 00036 | Denmark | Start Trial | |
| 0641330 | SPC/GB04/034 | United Kingdom | Start Trial | PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/ |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
