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BLA

SOMAPACITAN-BECO | B761156 | NOVO NORDISK INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

August 28, 2032(2248 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 28, 2032	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Mar. 2, 20436086 days remaining

Based on latest discovered patent 11596747(device) · 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 30 patents →

30 AI-discovered patents, sorted by relevance.

Composition

(7)

82/1009242011Grant: 2016-01-26 | Exp: 2036-01-21

75/1009187546Grant: 2015-11-17 | Exp: 2035-11-12

65/1007235638Grant: 2007-06-26 | Exp: 2027-06-21

65/1009067977Grant: 2015-06-30 | Exp: 2035-06-25

60/1009708383Grant: 2017-07-18 | Exp: 2037-07-13

55/1008916360Grant: 2014-12-23 | Exp: 2034-12-18

50/10010919949Grant: 2021-02-16 | Exp: 2041-02-11

Formulation

(1)

50/1009387176Grant: 2016-07-12 | Exp: 2036-07-07

Method of Use

(2)

75/1008586532Grant: 2013-11-19 | Exp: 2033-11-14

65/1007141548Grant: 2006-11-28 | Exp: 2026-11-23

Manufacturing

(9)

60/1006933136Grant: 2005-08-23 | Exp: 2025-08-18

55/1007276590Grant: 2007-10-02 | Exp: 2027-09-27

55/1006566490Grant: 2003-05-20 | Exp: 2023-05-15

55/1006183989Grant: 2001-02-06 | Exp: 2021-02-01

55/1007521210Grant: 2009-04-21 | Exp: 2029-04-16

50/1006451987Grant: 2002-09-17 | Exp: 2022-09-12

50/1007595172Grant: 2009-09-29 | Exp: 2029-09-24

50/1008637647Grant: 2014-01-28 | Exp: 2034-01-23

50/1007402565Grant: 2008-07-22 | Exp: 2028-07-17

Device

(11)

65/1006755810Grant: 2004-06-29 | Exp: 2024-06-24

55/10010376652Grant: 2019-08-13 | Exp: 2039-08-08

55/1008348905Grant: 2013-01-08 | Exp: 2033-01-03

55/10011311679Grant: 2022-04-26 | Exp: 2042-04-21

55/1006461334Grant: 2002-10-08 | Exp: 2022-10-03

55/1008617125Grant: 2013-12-31 | Exp: 2033-12-26

50/10010245383Grant: 2019-04-02 | Exp: 2039-03-28

50/1009861755Grant: 2018-01-09 | Exp: 2038-01-04

50/1009144647Grant: 2015-09-29 | Exp: 2035-09-24

50/10011596747Grant: 2023-03-07 | Exp: 2043-03-02

50/1006716198Grant: 2004-04-06 | Exp: 2024-04-01

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 761156 | 3 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

somapacitan-beco

Applicant

Novo Nordisk Inc.

Approval Date

28-Aug-20

Presentations

10MG/1.5ML (6.7MG/ML) — Autoinjector (Subcutaneous)

5MG/1.5ML (3.3MG/ML) — Autoinjector (Subcutaneous)

15MG/1.5ML (10MG/ML) — Autoinjector (Subcutaneous)

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Mar 3, 2026	SUPPL -15	View Letter (PDF)
Mar 3, 2026	SUPPL -14	View Letter (PDF)
Mar 3, 2026	SUPPL -12	View Letter (PDF)
Jul 11, 2025	SUPPL -13	View Letter (PDF)
Feb 6, 2025	SUPPL -6	View Letter (PDF)
May 1, 2023	SUPPL -5	View Letter (PDF)
Oct 5, 2021	SUPPL -2	View Letter (PDF)
Oct 5, 2021	SUPPL -1	View Letter (PDF)
Sep 1, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/1.5ML

▴

SOLUTION;SUBCUTANEOUS | Approved: 2020-08-28 00:00:00

No patent or exclusivity listings for this strength.