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Risperdal Consta®(risperidone) Extended-release Injection
Company JANSSEN
Date of First Filing Not applicableParagraph IV Applicant: Luye Pharma Group
Case Name: ALKERMES PHARMA IRELAND LIMITED et al v. LUYE PHARMA GROUP LTD et al
Court/Case #: Delaware District Court (dedc) 1:2019cv01340
Date Filed: 7/17/19
Judge: Stark
Product…Read more
Bryhali(tm)(halobetasol) Lotion
Company BAUSCH HEALTH
Date of First Filing March 20, 2019Paragraph IV Applicant: Glenmark
Case Name: BAUSCH HEALTH IRELAND LIMITED v. GLENMARK PHARMACEUTICALS LIMITED
Court/Case #: New Jersey District Court (njdc) 3:2019cv14502
Date Filed: 6/28/19
Judge: Wolfson
Product Strength: 0.01%
Litigated…Read more
The Paragraph Four Report®
Paragraph IV Activity for June 2019New Certifications as reported by FDA on June 18, 2019
1. Bryahli®(halobetasol) Lotion 0.01% on 3/20/2019
2. Horizant®(gabapentin) Extended-release Tablets on 4/29/2019Comments: While the molecules from the June 18 FDA List have seen PIV action in the past, it is worthy to…Read more
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Latest Updates
Risperdal Consta®(risperidone) Extended-release Injection
Company JANSSEN
Date of First Filing Not applicableParagraph IV Applicant: Luye Pharma Group
Case Name: ALKERMES PHARMA IRELAND LIMITED et al v. LUYE PHARMA GROUP LTD et al
Court/Case #: Delaware District Court (dedc) 1:2019cv01340
Date Filed: 7/17/19
Judge: Stark
Product…Read more
Bryhali(tm)(halobetasol) Lotion
Company BAUSCH HEALTH
Date of First Filing March 20, 2019Paragraph IV Applicant: Glenmark
Case Name: BAUSCH HEALTH IRELAND LIMITED v. GLENMARK PHARMACEUTICALS LIMITED
Court/Case #: New Jersey District Court (njdc) 3:2019cv14502
Date Filed: 6/28/19
Judge: Wolfson
Product Strength: 0.01%
Litigated…Read more
The Paragraph Four Report®
Paragraph IV Activity for June 2019New Certifications as reported by FDA on June 18, 2019
1. Bryahli®(halobetasol) Lotion 0.01% on 3/20/2019
2. Horizant®(gabapentin) Extended-release Tablets on 4/29/2019Comments: While the molecules from the June 18 FDA List have seen PIV action in the past, it is worthy to…Read more
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Latest updates
Risperdal Consta®(risperidone) Extended-release Injection
Company JANSSEN
Date of First Filing Not applicableParagraph IV Applicant: Luye Pharma Group
Case Name: ALKERMES PHARMA IRELAND LIMITED et al v. LUYE PHARMA GROUP LTD et al
Court/Case #: Delaware District Court (dedc) 1:2019cv01340
Date Filed: 7/17/19
Judge: Stark
Product…Read more
Bryhali(tm)(halobetasol) Lotion
Company BAUSCH HEALTH
Date of First Filing March 20, 2019Paragraph IV Applicant: Glenmark
Case Name: BAUSCH HEALTH IRELAND LIMITED v. GLENMARK PHARMACEUTICALS LIMITED
Court/Case #: New Jersey District Court (njdc) 3:2019cv14502
Date Filed: 6/28/19
Judge: Wolfson
Product Strength: 0.01%
Litigated…Read more
The Paragraph Four Report®
Paragraph IV Activity for June 2019New Certifications as reported by FDA on June 18, 2019
1. Bryahli®(halobetasol) Lotion 0.01% on 3/20/2019
2. Horizant®(gabapentin) Extended-release Tablets on 4/29/2019Comments: While the molecules from the June 18 FDA List have seen PIV action in the past, it is worthy to…Read more
Login
Latest updates
Risperdal Consta®(risperidone) Extended-release Injection
Company JANSSEN
Date of First Filing Not applicableParagraph IV Applicant: Luye Pharma Group
Case Name: ALKERMES PHARMA IRELAND LIMITED et al v. LUYE PHARMA GROUP LTD et al
Court/Case #: Delaware District Court (dedc) 1:2019cv01340
Date Filed: 7/17/19
Judge: Stark
Product…Read more
Bryhali(tm)(halobetasol) Lotion
Company BAUSCH HEALTH
Date of First Filing March 20, 2019Paragraph IV Applicant: Glenmark
Case Name: BAUSCH HEALTH IRELAND LIMITED v. GLENMARK PHARMACEUTICALS LIMITED
Court/Case #: New Jersey District Court (njdc) 3:2019cv14502
Date Filed: 6/28/19
Judge: Wolfson
Product Strength: 0.01%
Litigated…Read more
The Paragraph Four Report®
Paragraph IV Activity for June 2019New Certifications as reported by FDA on June 18, 2019
1. Bryahli®(halobetasol) Lotion 0.01% on 3/20/2019
2. Horizant®(gabapentin) Extended-release Tablets on 4/29/2019Comments: While the molecules from the June 18 FDA List have seen PIV action in the past, it is worthy to…Read more
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