Emgality (galcanezumab-gnlm)

BL 761063

Emgality (galcanezumab-gnlm)

BL 761063

U.S. License Holder:

Eli Lilly & Co.

Date of License:

September-27-2018

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


EMGALITY (galcanezumab-gnlm) is a calcitonin-gene related peptide antagonist indicated for the preventive treatment of migraine in adults.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
9,340,614 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Formulation

IPR Status
Institution Decision Pending

U.S. Patent No.
9,266,951 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Formulation

IPR Status
Institution Decision Pending

U.S. Patent No.
9,346,881 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Formulation

IPR Status
Institution Decision Pending

U.S. Patent No.
9,890,210 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter

IPR Status
Institution Decision Pending

U.S. Patent No.
9,890,211 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter

IPR Status
Institution Decision Pending

U.S. Patent No.
8,597,649 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Formulation

IPR Status
Institution Decision Pending

U.S. Patent No.
8,586,045 (Methods of Using Anti-CGRP Antagonist Antibodies)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

IPR Status
Institution Decision Pending

U.S. Patent No.
9,884,907 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

IPR Status
Institution Decision Pending

U.S. Patent No.
9,884,908 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

IPR Status
Institution Decision Pending

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
8,586,045 (Methods of Using Anti-CGRP Antagonist Antibodies) 8,597,649 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,266,951 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,340,614 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,346,881 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same)

Plaintiffs
Teva Pharmaceuticals International GmbH, Teva Pharmaceuticals USA, Inc.

Defendants
Eli Lilly & Co.

Status
Dismissed

BPCIA
N

U.S. Patent Nos.
9,884,907 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,884,908 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,210 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,211 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Plaintiffs
Teva Pharmaceuticals International GmbH; Teva Pharmaceuticals USA, Inc.

Defendants
Eli Lilly & Co.

Status
Dismissed

BPCIA
N

U.S. Patent Nos.
8,586,045 (Methods of Using Anti-CGRP Antagonist Antibodies) 8,597,649 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,266,951 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,340,614 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,346,881 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,884,907 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,884,908 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,210 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,211 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Plaintiffs
Teva Pharmaceuticals International GmbH, Teva Pharmaceuticals USA, Inc.

Defendants
Eli Lilly & Co.

Status
Case Ongoing

BPCIA
N

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Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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