When will the NORTREL 0.5/35-21 patents expire, and when will generic NORTREL 0.5/35-21 be available?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Barr	NORTREL 0.5/35-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	072692-001	Feb 28, 1992		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: May 28, 2026

Executive summary

Asset: NORTREL 0.5/35-21 is an oral contraceptive (21 active tablets per 28-day cycle) containing norethindrone acetate 0.5 mg and ethinyl estradiol 35 mcg.
Market economics: This is a mature, low-to-mid priced generic/“shared brand” category where value is driven by NDC breadth, payer contracting, distribution depth, and product defensibility via labeling/formulation/packaging rather than new molecular exclusivity.
IP reality: For a decades-old oral contraceptive combination, the investment risk is dominated by expiration of composition-of-matter and most use/formulation patents, plus high generic interchangeability. The practical investment question is not “will generics exist,” but “how fast and how many.”
Commercial path: Winning strategy is typically low COGS manufacturing, continuous product supply, and switch-resistance via package/patient compliance (e.g., “21/28 day” cycle consistency, manufacturing robustness, and supply reliability).

What is NORTREL 0.5/35-21 and how does it map to the oral contraceptive market?

Direct answer: NORTREL 0.5/35-21 is a combined oral contraceptive (COC) regimen with norethindrone acetate (progestin) and ethinyl estradiol (estrogen). It is marketed in a 21 active tablet cycle, typically followed by 7 inert tablets.

How COC fundamentals shape investment returns

Demand is persistent but commoditized: contraception usage is stable, but brands compete on contracting and availability.
Channel power: pharmacy benefit managers and large chains drive outcomes through preferred formularies and substitution.
Switching friction is limited: clinical switching is routine for many patients, so share gains often hinge on pricing and coverage more than differentiated product attributes.

Competitive landscape: “therapeutic but not differentiated”

Within COCs, multiple branded and generic equivalents exist across:

progestin variants (including norethindrone acetate and others),
ethinyl estradiol dose levels,
dosing cycle patterns (21/7, 24/4, continuous regimens).

For investors, the implication is clear: NORTREL’s value is mostly distribution and procurement, not moat.

What patents protect NORTREL 0.5/35-21 and how many are likely still enforceable?

Direct answer: For an established norethindrone acetate/ethinyl estradiol combination at standard dose levels, the composition-of-matter and core use coverage typically expires long before the present day. Any remaining enforceability usually comes from minor formulation, packaging, or manufacturing process patents, if they exist and are timely listed.

Practical IP framework investors should apply

Because the product is a classic COC combination, an investment-grade patent estate evaluation should be structured around:

Orange Book listings (if any) for the exact strength and dosage form.
Patent types still active at the investment horizon:
- use patents tied to specific indications or dosing instructions,
- method patents tied to manufacturing or formulation parameters,
- formulation patents (release, dissolution, particle size) only if they meet novelty.
Family-level status: if a family contains old priority dates, most members are usually expired or near-expiry.

What this usually means for commercialization

If no currently active patents cover the specific marketed drug product, a generic entrant can compete on price and availability.
If there are late-cycle formulation or process patents, the economic effect can be limited unless:
- the claimed change is necessary for generic bioequivalence, or
- the patent imposes a design-around barrier that delays ANDA approval or launch.

When does NORTREL 0.5/35-21 lose exclusivity?

Direct answer: For mature COCs, “exclusivity loss” is usually driven by patent expiration of listed Orange Book patents and any granted regulatory exclusivities at the NDA/labeling level. In practice, most products in this class have already passed key exclusivity milestones.

Exclusivity timeline investors should use for scenario modeling

For oral contraceptive products, the model typically treats the following as the exclusivity/entry gates:

Brand NDA exclusivity (if any remnants exist due to life-cycle changes).
Listed patent expiration for the specific drug/strength.
180-day generic exclusivity: a key driver of near-term price compression if a Paragraph IV filer wins first-to-market.

What generic entry risks exist for NORTREL 0.5/35-21 and how fast does pricing fall?

Direct answer: The entry risk is structurally high due to the category’s generic maturity. Once a generic is launched on the market, price erosion is typically rapid and sustained through PBM contracting.

Entry vectors that matter economically

ANDA approvals aligned with the listed product definition (strength, dosage form, dosing regimen).
Switching and substitution: if the formulation is substitutable and therapeutically equivalent, the brand’s share depends on contractual placement.
Multiple generic launches: each additional supplier accelerates price compression and increases volume bargaining power.

Scenario structure for investors

A common model uses three states:

Pre-major generic competitive wave: brand holds more stable revenue.
First wave launch: measurable loss of share and margin.
Second wave / multiple generics: further erosion and ongoing discounting until the market stabilizes at a low net price level.

How strong is the patent estate for norethindrone acetate/ethinyl estradiol COCs specifically?

Direct answer: Patent estates in older COC combinations generally have weak incremental protection beyond the early period after origin. Remaining protection, if any, tends to be narrow and can be bypassed.

How to assess estate strength without narrative

Investors should quantify:

Number of active Orange Book patents per listed NDA (exact product/strength).
Claims coverage overlap with likely generic designs.
Time to expiration for each active patent.
Litigation or regulatory history: repeated Paragraph IV challenges often indicate predictable generic entry.

What formulations are protected: tablets, dosing regimen, and product presentation?

Direct answer: For COCs, key “formulation” protection targets are usually limited to:

tablet composition or excipient changes,
dissolution/release specifications,
stability-driven formulation revisions,
packaging or labeling-driven life-cycle changes.

What typically is not protectable at scale

Basic combination identity (progestin + ethinyl estradiol) is usually too old for meaningful current protection.
Generic bioequivalence standards reduce the room for differentiation if the product must remain therapeutically equivalent.

What Orange Book status does NORTREL 0.5/35-21 have?

Direct answer: This requires Orange Book listing data for the exact branded drug product. Without a verified Orange Book record for NORTREL 0.5/35-21 (NDA number, active ingredient entries, dosage form, strength, and listed patents), no defensible status call can be made.

What patent litigation affects NORTREL 0.5/35-21 and similar COCs?

Direct answer: Liability and timing for generics are driven by active litigation, not category-level expectation. Without case-level data for the exact branded product and its relevant Orange Book patents, a litigation impact assessment cannot be produced.

What FDA regulatory pathway governs NORTREL 0.5/35-21 and its generics/biosimilars?

Direct answer: NORTREL is an NDA-type small-molecule drug product. Its generic competitors typically file ANDAs with bioequivalence to the reference listed drug.

Why biosimilar analysis is irrelevant here

This is not a biologic product. Biosimilar pathways do not apply.

Which companies are positioned to compete with NORTREL 0.5/35-21?

Direct answer: Generic competition for COCs is usually dominated by multi-product generic manufacturers and authorized generic programs, but company identification requires:

Orange Book ANDA/ANDA filer history for the exact reference product,
ANDA applicant names, approval status, and launch dates.

Without verified filer data tied to NORTREL 0.5/35-21, competitor ranking would be speculative.

How does NORTREL 0.5/35-21 compare with other norethindrone acetate/ethinyl estradiol COC strengths?

Direct answer: Economic performance is usually determined by:

payer preference among strength variants,
relative price,
availability and contract terms,
patient adherence driven by cycle pattern.

What drives switching among COCs in practice

formulary positioning for equivalent COCs,
copay tiers,
supply continuity,
minor label differences such as dosing instructions and contraindication language (which can still be therapeutically equivalent for many users).

Commercial revenue exposure: what share and pricing dynamics should investors expect?

Direct answer: Without verified current sales and distribution metrics for NORTREL 0.5/35-21 (brand net sales by NDC, unit volume, channel mix), no quantified revenue exposure can be responsibly stated.

What is still actionable for fundamentals under commoditization

Investors should treat the investment case as a function of:

gross margin resilience (COGS and rebates),
contract discipline (PBM placement and rebate structures),
supply risk (manufacturing continuity, recall history, capacity constraints),
NDC portfolio strength (if brand is offered in multiple pack sizes/strengths).

Key Takeaways

NORTREL 0.5/35-21 is a mature combined oral contraceptive where investment performance is driven by pricing, contracting, and supply reliability more than by enduring molecular IP.
For older norethindrone acetate/ethinyl estradiol combinations, current patent exclusivity is usually limited to narrow, late-cycle protection that often does not stop generics.
The decisive investment risks are generic entry speed, number of launch competitors, and PBM-driven price erosion.
A patent- and litigation-led forecast for this specific branded product requires verified Orange Book/NDA listing and case data for NORTREL 0.5/35-21; without that, no defensible exclusivity, expiration, or Paragraph IV conclusions can be produced.

FAQs

Does NORTREL 0.5/35-21 have Orange Book listed patents that block generic substitution?
How do Paragraph IV ANDA challenges typically affect oral contraceptive pricing and brand share?
What is the typical timeline from ANDA approval to market price erosion for mature COCs?
Do tablet formulation or stability patents meaningfully delay generic launches for older COCs?
What commercial KPIs matter most for sustaining profitability of an oral contraceptive brand amid generic competition?

References

FDA, Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations (accessed via FDA Orange Book database).
FDA, Approved Drug Products and Therapeutic Equivalence Evaluations (Orange Book) guidance and related regulatory resources.

NORTREL 0.5/35-21 Drug Patent Profile

Which patents cover Nortrel 0.5/35-21, and what generic alternatives are available?

AI Deep Research

Questions you can ask:

Summary for NORTREL 0.5/35-21

US Patents and Regulatory Information for NORTREL 0.5/35-21

Nortrel 0.5/35-21 (Norethindrone Acetate/Ethinyl Estradiol) Investment Scenario and Patent-Led Fundamentals Analysis