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ELSPAR

BLA

ASPARAGINASE | B101063 | MERCK

1 product0 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

Oct. 9, 20457038 days remaining

Based on latest discovered patent 12441992(composition) · relevance 92/100

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

Discovered Patents

View all 23 patents →

23 AI-discovered patents, sorted by relevance.

Composition

(15)

95/1009353366Grant: 2016-05-31 | Exp: 2036-05-26

92/10012441992Grant: 2025-10-14 | Exp: 2045-10-09

92/10011046946Grant: 2021-06-29 | Exp: 2041-06-24

92/10011504418Grant: 2022-11-22 | Exp: 2042-11-17

92/1006251388Grant: 2001-06-26 | Exp: 2021-06-21

90/1008980843Grant: 2015-03-17 | Exp: 2035-03-12

89/10012121571Grant: 2024-10-22 | Exp: 2044-10-17

88/10010174302Grant: 2019-01-08 | Exp: 2039-01-03

85/10011802279Grant: 2023-10-31 | Exp: 2043-10-26

85/1009051561Grant: 2015-06-09 | Exp: 2035-06-04

85/1009920311Grant: 2018-03-20 | Exp: 2038-03-15

72/1009333268Grant: 2016-05-10 | Exp: 2036-05-05

70/1007160693Grant: 2007-01-09 | Exp: 2027-01-04

68/1009789170Grant: 2017-10-17 | Exp: 2037-10-12

68/1007498029Grant: 2009-03-03 | Exp: 2029-02-26

Formulation

(1)

95/10012343387Grant: 2025-07-01 | Exp: 2045-06-26

Method of Use

(5)

92/1009181552Grant: 2015-11-10 | Exp: 2035-11-05

90/10011141468Grant: 2021-10-12 | Exp: 2041-10-07

90/1007985548Grant: 2011-07-26 | Exp: 2031-07-21

78/1009731028Grant: 2017-08-15 | Exp: 2037-08-10

60/1006719977Grant: 2004-04-13 | Exp: 2024-04-08

Manufacturing

(2)

88/1006991788Grant: 2006-01-31 | Exp: 2026-01-26

88/1007807436Grant: 2010-10-05 | Exp: 2030-09-30

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 101063

351(a) ReferenceLicensedCDERFor Injection

Proper Name

asparaginase

Applicant

Recordati Rare Diseases, Inc.

Approval Date

10-Jan-78

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jul 18, 2013	SUPPL -5169	View Letter (PDF)
Apr 20, 2007	SUPPL -5081	View Letter (PDF)
Jul 25, 2006	SUPPL -5071	View Letter (PDF)
Jul 7, 2004	SUPPL -5036	View Letter (PDF)
Mar 12, 2004	SUPPL -5012	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10,000IU/VIAL

▴

VIAL | Approved: 1978-01-10 00:00:00

No patent or exclusivity listings for this strength.