Viewing data from:

ACTIVASE

BLA

ALTEPLASE | B103172 | GENENTECH

3 products0 Purple Book patents

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jul. 24, 20456961 days remaining

Based on latest discovered patent 12371728(manufacturing) · relevance 50/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Discovered Patents

View all 62 patents →

Top 50 of 62 AI-discovered patents by relevance.

Composition

(9)

78/1009999679Grant: 2018-06-19 | Exp: 2038-06-14

75/1007271143Grant: 2007-09-18 | Exp: 2027-09-13

72/1008071091Grant: 2011-12-06 | Exp: 2031-12-01

68/1007098003Grant: 2006-08-29 | Exp: 2026-08-24

65/1007157556Grant: 2007-01-02 | Exp: 2026-12-28

60/1009878018Grant: 2018-01-30 | Exp: 2038-01-25

55/1006210667Grant: 2001-04-03 | Exp: 2021-03-29

52/1007005504Grant: 2006-02-28 | Exp: 2026-02-23

50/10011440971Grant: 2022-09-13 | Exp: 2042-09-08

Formulation

(5)

88/1007084118Grant: 2006-08-01 | Exp: 2026-07-27

82/1007829082Grant: 2010-11-09 | Exp: 2030-11-04

55/1008945543Grant: 2015-02-03 | Exp: 2035-01-29

55/10011865177Grant: 2024-01-09 | Exp: 2044-01-04

50/1007611709Grant: 2009-11-03 | Exp: 2029-10-29

Method of Use

(6)

89/10011692037Grant: 2023-07-04 | Exp: 2043-06-29

88/1009023346Grant: 2015-05-05 | Exp: 2035-04-30

78/10012036384Grant: 2024-07-16 | Exp: 2044-07-11

72/1009381166Grant: 2016-07-05 | Exp: 2036-06-30

65/1006787135Grant: 2004-09-07 | Exp: 2024-09-02

60/1006503947Grant: 2003-01-07 | Exp: 2023-01-02

Manufacturing

(26)

93/1006284247Grant: 2001-09-04 | Exp: 2021-08-30

90/1006274335Grant: 2001-08-14 | Exp: 2021-08-09

90/1006261837Grant: 2001-07-17 | Exp: 2021-07-12

88/1006955910Grant: 2005-10-18 | Exp: 2025-10-13

86/1007462476Grant: 2008-12-09 | Exp: 2028-12-04

82/1006828118Grant: 2004-12-07 | Exp: 2024-12-02

60/10010421950Grant: 2019-09-24 | Exp: 2039-09-19

58/1006846673Grant: 2005-01-25 | Exp: 2025-01-20

55/1007651848Grant: 2010-01-26 | Exp: 2030-01-21

55/1007087412Grant: 2006-08-08 | Exp: 2026-08-03

55/10010723762Grant: 2020-07-28 | Exp: 2040-07-23

55/10010155970Grant: 2018-12-18 | Exp: 2038-12-13

55/1007049131Grant: 2006-05-23 | Exp: 2026-05-18

55/1006528286Grant: 2003-03-04 | Exp: 2023-02-27

55/1009994612Grant: 2018-06-12 | Exp: 2038-06-07

55/10010377793Grant: 2019-08-13 | Exp: 2039-08-08

52/10012274960Grant: 2025-04-15 | Exp: 2045-04-10

50/1008372959Grant: 2013-02-12 | Exp: 2033-02-07

50/10010501491Grant: 2019-12-10 | Exp: 2039-12-05

50/1006270988Grant: 2001-08-07 | Exp: 2021-08-02

50/1006333175Grant: 2001-12-25 | Exp: 2021-12-20

50/1008349615Grant: 2013-01-08 | Exp: 2033-01-03

50/10012344859Grant: 2025-07-01 | Exp: 2045-06-26

50/10012371728Grant: 2025-07-29 | Exp: 2045-07-24

50/1009683252Grant: 2017-06-20 | Exp: 2037-06-15

50/1009284347Grant: 2016-03-15 | Exp: 2036-03-10

Diagnostic

(4)

75/1006593097Grant: 2003-07-15 | Exp: 2023-07-10

70/1009599625Grant: 2017-03-21 | Exp: 2037-03-16

60/10010254295Grant: 2019-04-09 | Exp: 2039-04-04

52/1008227195Grant: 2012-07-24 | Exp: 2032-07-19

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 103172 | 3 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

alteplase

Applicant

Genentech, Inc.

Approval Date

13-Nov-87

Presentations

50MG — Single-Dose Vial (Intravenous)

100MG — Single-Dose Vial (Intravenous)

2MG — Single-Dose Vial (Intravenous)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Sep 2, 2022	SUPPL -5268	View Letter (PDF)
Oct 9, 2020	SUPPL -5267	View Letter (PDF)
Mar 2, 2018	SUPPL -5259	View Letter (PDF)
Mar 2, 2018	SUPPL -5260	View Letter (PDF)
Jul 6, 2017	SUPPL -1055	View Letter (PDF)
Jul 5, 2017	SUPPL -5253	View Letter (PDF)
Feb 17, 2015	SUPPL -5203	View Letter (PDF)
Mar 12, 2004	SUPPL -5003	View Letter (PDF)
Mar 10, 2004	SUPPL -5009	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MG/VIAL

▴

VIAL; SINGLE-USE | Approved: 1987-11-13 00:00:00

No patent or exclusivity listings for this strength.

#002 — 50MG/VIAL

▾

VIAL; SINGLE-USE | Approved: 1987-11-13 00:00:00

#003 — 2MG/VIAL

▾

VIAL | Approved: 1987-11-13 00:00:00