Somatropin - Biologic Drug Details

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Summary for somatropin

Tradenames:	11
High Confidence Patents:	17
Applicants:	9
BLAs:	10
Suppliers: see list	7
Recent Clinical Trials:	See clinical trials for somatropin
Drug Prices:	Drug price information for somatropin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for somatropin

Recent Clinical Trials for somatropin

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Northwell Health	Phase 3
Beni-Suef University	Phase 2/Phase 3
Ascendis Pharma Endocrinology Division A/S	Phase 2

See all somatropin clinical trials

Recent Litigation for somatropin

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC.	2024-02-05
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
Novo Nordisk, Inc. v. Mylan Pharmaceuticals, Inc.	2022-08-08

See all somatropin litigation

PTAB Litigation

Petitioner	Date
	2017-05-19

See all somatropin litigation

Pharmacology for somatropin

Established Pharmacologic Class	Recombinant Human Growth Hormone
Chemical Structure	Human Growth Hormone

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for somatropin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for somatropin Derived from Company Disclosures

These patents were obtained from company disclosures

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	⤷ Sign Up		Company disclosures
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	⤷ Sign Up		Company disclosures
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	⤷ Sign Up	2013-03-15	Company disclosures
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	⤷ Sign Up		Company disclosures
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	⤷ Sign Up	2014-05-06	Company disclosures
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	⤷ Sign Up		Company disclosures
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	⤷ Sign Up		Company disclosures
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Patent No.	>Estimated Patent Expiration	>Source

3) Low Certainty: US Patents for somatropin Derived from Patent Text Search

These patents were obtained by searching patent claims